clinical research organization pune

• 501/514, Crossroad Building, Bhumkar square, Wakad, Pune 411057
• Mon - Sat 10.00 - 06.00

A leading global contract research organisation in Asia

NUTRACEUTICAL

Clinical research, make clinically, proven product.

Global Reach of MPREX

Claim validation of nutraceutical through clinical research.

Claim validation for nutraceuticals involves rigorous scientific investigation to substantiate the health-related assertions associated with these products. It is important to validate nutraceuticals to guarantee that the products are of the highest caliber, fulfill all requirements, and are produced with the right procedures. Validation of the nutraceuticals helps to reduce the risks related to the products and processes. It is well accepted by the patients and clients if the product is validated.

Your benefits

• Regulatory compliance
• ASCI support
• Dosage performance assessment
• Proof for safety and efficacy
• Market Differentiation
• E-Com Support
• Consumer Confidence
• FSSAI Claim

Years Of Experience

About mprex, our infrastructure – reach and credibility, studies completed, investigators & sites, publications, countries presence, we offer services, we provide assistance in various directions, clinical trials.

Our clinical trial services range from Pilot studies, Proof of concept studies to large Multicentric clinical studies for evaluating efficacy and safety in humans. We offer customized study designs to validate all product-related health and marketing claims.

PHARMACOKINETIC STUDIES

We conduct bioavailability and pharmacokinetic (PK) studies for herbal actives, natural ingredients, protein supplements, etc. These studies can substantiate product claims and differentiate products from the non-standardized competition.

PRECLINICAL SERVICES

We are conducting preclinical and toxicity studies in GLP and non-GLP preclinical laboratories. We conduct proof of concept to establish the product’s mechanism of action. We assess pharmacokinetics and pharmacodynamics to validate efficacy and evaluate safety parameters to ensure regulatory compliance.

PROJECT MANAGEMENT

Our team offer services to ensure efficient planning, execution and completion of research projects. It involves coordinating timelines, managing budgets, maintaining communication to meet client objectives, regulatory requirement and quality standards.

IN VITRO STUDIES

In our laboratory, the products efficacy and safety is tested with outmost accuracy to provide better results. Our rigorous protocols and state-of-the-art equipment guarantee precise data collection for reliable analysis.

COSMETIC & DERMATOLOGY STUDIES

We conduct clinical studies in dermatology for dermatitis, psoriasis, acne, skin allergies, rashes, baby products, etc. We conduct clinical trials in anti-aging and other claim-substantiating studies for skin and hair care products.

Golden Journey Of MPREX

The inception of MPREX GROUP offering Site Management Services for clinical trials.

Added product development services, pathology labs and began specializing in Nutraceutical research.

We unfolded our wings and introduced preclinical, toxicity, in-vitro study services

The Mprex Foundation was registered and clinical trial sites expanded in variety of therapeutic areas.

Began conducting clinical trials for overseas clients as part of global expansion strategy for development.

Marked footprint in cosmetic clinical trials, and developed a skin and hair lab. Started Mprex Biotech, delivering research in the agriculture industry.

Developed Bioanalytical research facility and services for Nutraceuticals. Mprex is expanding at an exponential pace.

Operations Began started Mprex-USA Mpres-Biotech

What to write?

Specialized Clinical Research Needs.

Unveiling the science of clinical research in your nutraceuticals, whatsapp - 8554912644.

TESTIMONIALS

Happy clients of mprex.

“Explore our testimonials to uncover the success stories behind our innovative clinical trials, as shared by our valued partners.”

Third Testimonial

Mprex Healthcare provided exceptional care and tailored attention to my requirements, with consistently friendly and supportive staff who ensured my comfort and value as a client. Their profound expertise in healthcare services significantly contributed to my journey towards improved health. I am sincerely appreciative of the positive experience I encountered with Mprex Healthcare.

Ashley Foster

Mprex Healthcare Pvt. Ltd consistently delivers exceptional service, exceeding our expectations every time. Their dedication to excellence, timely delivery, and proactive communication have significantly contributed to our success. We highly recommend Mprex for their unparalleled commitment to customer satisfaction and quality healthcare solutions.

Mprex consistently offers outstanding service, presenting inventive solutions with the highest level of professionalism. Their commitment to ensuring client satisfaction shines through in every encounter. I wholeheartedly endorse them for their dependability and mastery in the field of Clinical Research.

Happy associates & clients of Mprex

Product transformation

Transform Your Product Potential with Mprex’s Clinical Trial Services

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• Nyati Unitree, Yerwada, Pune
• Mon - Fri : 9:00 AM - 6:00 PM

Company Achievements and Recognition's

Our audits and vendor qualifications, our publications.

About Ardent Clinical Research Services Pvt Ltd.

Ardent Clinical Research Services Pvt Ltd is one of India’s leading providers of integrated clinical research services having operational facilities in Pune, MH, India. We have been successfully serving to a wide range of clientele comprising of biopharmaceutical, Herbal, Neutraceutical, Device companies and generic drug industry. Our broad spectrum of superior quality services are designed to meet our customers’ specific needs. The team of experts at Ardent offers management and leadership solutions to clinical researchers to ensure that their project starts on the right foot. Apart from a timely start, an efficient execution and delivery of clinical trial projects is ascertained. We’re equipped with ICH GCP, Standard Operating Procedures (SOPs) and all our clinical trial activities strictly comply with the regulatory principles and guidelines. As we conform to the highest standards of ethics, the patients under investigation can rest assured about their safety and confidentiality. With our exhaustive investigator database and technical expertise in diverse areas of therapeutic research, we enable faster patient recruitment, cost-effective trials and a world-class clinical support. But what really sets us apart from our peers is our quick turnaround times and the personal attention, we pay to our customers.

Ardent Health Values

Our mission is encapsulated in providing a conducive system for clinical trials, experiments & observational studies, tailored to specific requirements, to respond to rising burden of diseases & growing demand for innovation in drugs and medical devices.

We envision ourselves going beyond the development of new drugs, diagnostic tools & treatments, to contributing in planning of healthcare services, facilitating continuous evaluation & progress of medical care, with a thorough investigation of risk-factors.

Welcome To Ardent Clinical Research Services

Providing the best and quality services of clinical trials in the industry..

Ardent Clinical Research Services is western India’s one of the top-notch full-service clinical research organizations, operating from Pune, Maharashtra and Hyderabad India 

• A - Attention to Detail

We at Ardent Clinical Research Services ensure that we carefully review and understand the client requirement.

• R - Responsibility

Concern for the Society and the people living in it is a Responsibility of a good organization

• D - Diversity

We at Ardent come from different backgrounds and different regions of India.

• E - Excellence

Striving for excellence is not doing different things its just doing things differently.

• N - Nobility

Nobility and Ethics are the values which we are proud to follow as an Organization.

• T - Teamwork

We believes in absolute teamwork. We support and encourage the participation of employees at all levels to give any kind of feedback.

Founder and Managing Director – Ardent Clinical Research Services

• Founder of the Company is Mr. Chandu Gangadhar Devanpally who holds Post Graduation in Bio-chemistry and Diploma in Clinical Research from Nagpur.
• He has started his career in the Department of Clinical Trials at Sushrut Hospital and Research Center, Nagpur in the year 2007.
• He is an experienced entrepreneur and has successfully launched various organizations for different industries.
• He is meticulous, goal-oriented entrepreneurial seasoned professional with hands-on real-time experience of End-to-End Clinical Trial Project Management, Data Management and Business Development for Clinical trials.
• A keen strategist with the ability to understand and articulate key opportunities in ever changing research industry.
• He has proficiency in planning, organizing, executing and training subordinates on protocol-based management and conduct of clinical trials.
• He had worked on various designations like CRC, CRA, Quality Manager and Operational Manager on various global and domestic trials.
• He is an effective communicator with excellent relationship management skills, problem solving and organizational abilities.
• His expertise is in Clinical Trial and Team Management, Business development, Project Management, Monitoring and Communications with various sponsors/vendors.

Different Types Of Departments

Medical writing.

Our medical writers compile new facts, ideas, thoughts & perceptions on drug & device-discoveries, which are nothing but a well-structured information to different audiences, including patients, consumers, physicians, drug regulators and other healthcare experts.

Regulatory Services

Our ability to assist sponsors obtaining regulatory approvals is supported by a deep understanding of, and experience in dealing with the Indian drug control regulations. We have the ability to provide services as a complete study management and/or as customized services.

Clinical Operations

Ardent Clinical Research Services (ACRS) Contract Research Organization’s Clinical Operation Department Helping You Design, Start-Up and Manage your entire Clinical Trials To Successful Completion, submission, and Regulatory Approvals.

Project Management

In our mechanism ensures that collaboration is maintained on each function of a project to manage all its operational aspects and quality, in terms of minimized risks & clean data, is delivered efficiently & timely, as per the GCP guidelines.

Safety Management

Through a team of dedicated and experienced Medical Monitors, we provide- highly credible inputs for the design of comprehensive study specific safety management plans, to ensure AE’s & SAEs are reported and processed accurately as per the regulatory guidelines.

Data Management

Ardent Clinical Research Services provides end to end comprehensive clinical data management services to the clients from Data Management Plan to Database Lock. The team works on a robust portfolio and strives to ensure the highest quality.Clinical Data Management Services Include :

Clinical trial monitoring

Clinical trial monitoring is a crucial part of trial conduct, improving the safety of the participants, the quality of the data and the trial integrity. Clinical trial monitoring is conducted by monitors, quality assurance teams and by trial managers

Medical monitoring

Medical monitoring is an essential component of the clinical research process. Medical monitors provide medical expertise and oversight for the entire clinical trial, from initial study design through final study close-out.

Site management

Site management in clinical research involves effective site monitoring and constant communication between the various stakeholders throughout all phases of the clinical study – study start-up, study conduct, and study closure.

Quality management

At ACRS, we understand the critical importance of quality in every aspect of the clinical trial we do. Our commitment to excellence is reflected in our comprehensive in-house Quality Management System (QMS),

Meet Our Team

Group of qualified and experienced team..

We are a team of qualified people who are having highly experience in clinical research and its management and have been working since last 10 years now.

Each one of our services is designed to meet our customers’ specific needs.

Ardent Clinical Research Services is western India’s one of the top-notch full-service clinical research organizations.

Deep technical expertise in diverse areas of therapeutic research.Access to ethnically diverse patient-population

OUR COLLABORATION

Ardent Clinical Research Services is one of India’s leading providers of personalized solutions in clinical development and consulting domain.

Actions (what is to be completed) Responsible person for each task Excellent training source for new employees and/or fellows.

OUR STRENGTHS

Our customers contribute to making us one of India’s most eminent providers of clinical development and consulting services.

OUR WORKING PRINCIPLES

The working procedures at Ardent Clinical Research Services are based on two-fold tenets but at the heart of these tenets, lie ethics, quality

OUR MEETING

it is a very positive sign when a potential sponsor agrees to meet with you. The situation is usually that you have sent your proposal to a potential sponsor.

Make An Appointment

Our Clients

Inspired Research

Better life needs better care, promising and advancing health care, company overview, purpose-built for biopharmaceutical acceleration.

Synergen Bio Private Limited is a DCGI(CDSCO) approved new age CRO with all necessary infrastructure to cater to the Pharmaceutical and Biotech industry, established by a group of enthusiastic professionalswith a vision to set-up a premium Clinical Research Organization known for its Quality, Knowledge and Expertise. Synergen Bio understands the importance of quality clinical research services and our significantly experienced team strives to provide the same to our sponsors at significant cost advantages. Representing a vertically integrated CRO, we offer customised solutions to suit sponsor requirements for the full spectrum of clinical research.

Full service Contract Research Organization

Synergen Bio is an Independent CRO which offers full spectrum clinical trial solutions to the biopharmaceutical and generic industry. Our mission is to become the preferred research partner in drug development process for our clients

• Nasal and Oral Inhalation drug BE study (MDI, DPI and nasal spray)
• Injectable Biosimilar drug BE studies
• Topical transdermal patch studies
• Intravenous Anesthetic drug BE study (e.g. Propofol)
• Topical Transdermal gel and cream based BE studies
• Patient PK studies
• Special population BE studies
• Population bio-equivalence

Our Services

Bioavailability & Bioequivalence

Bioanalytical

Clinical trials

Protocol Development & Medical Writing

Medical Services

Regulatory Affairs

Project Management

Quality Assurance

Pharmacokinetics & Biostatistics

Pharmacovigilance

• Company Insights
• New Registration
• Update Registration
• Phase 1 to 4 Clinical Trials
• Medical Monitoring
• Project Management
• Regulatory Affairs
• Site Selection
• Vendor Management
• Clinical Safety Services
• Clinical Operations
• Investigator Site Selection
• Site Selection and Management
• Patient Recruitment & Retention
• Data Management & Statistics
• Medical Writing
• Literature Services
• Signal detection and Report management
• Adverse Event Intake
• Case Processing
• Development and Implementation

Phase 1 to 4 Clinical Trial

Medical device clinical evaluation, software as a medical device clinical evaluation, bioequivalence clinical trials, biological clinical trials, herbal and nutraceutical clinical trials, in vitro diagnostics clinical evaluation, new drug and repurposed drug clinical trials, personalized medicine clinical trials, drug safety and pharmacovigilance services for us fda, drug safety and pharmacovigilance services for ema, drug safety and pharmacovigilance services for cdsco.

• CNS – Including Pain & Psychiatry
• Autoimmune / Inflammation
• Cardiovascular
• Opthalmology
• Endocrinology / Diabetology

Clinical Research Organization in US & India

Welcome to prorelix research cro, your drug development arm.

ProRelix Research is a Clinical Research Organization (CRO) with offices in the USA and India along with site networks in Australia, Thailand, Africa, and Europe supporting the clinical development of innovative new healthcare inventions and innovations to improve the health of patients. Every project is equally important to us. We first listen to you and strategize, aiming to a long-term partnership. We understand each project is unique on its own, and conscious clinical development, where efficiency is utmost and accuracy is supreme, is valuable and demanding to long-term success.

We provide services to help pharmaceutical, medical device, biopharmaceutical and nutraceutical/ herbal companies to transform scientific discoveries into new treatments. From clinical trial services, clinical data management services, pharmacovigilance services, medical writing services, drug regulatory affairs services, decentralized clinical trial services to leveraging real world insights, our therapeutic, technical, & operational ability is underpinned by a great conviction in what we do.

ProRelix Research has a global network of distinguished scientific leaders who are experts in a diverse range of therapeutic areas. We specialize in chronic diseases clinical trial services including oncology, respiratory, ophthalmology, endocrinology, immunology, dermatology, etc. Our reputation in clinical research services differentiates us from conventional clinical research organizations (CRO). We leverage our scientific leadership to establish and maintain the engagement of unique investigator networks for clinical research services.

Our Portfolio

Clinical trials play a pivotal role in the approval of new drugs as they most accurately reflect the effect of the drug in the human body. Since drug development is a costly and laborious process with the clinical trial phase...

Medical devices are an integral part of our lives from a simple thermometer to a life-saving pacemaker. Devising medical device clinical studies is complex and requires knowledge and experience-our experts at ProRelix Research can help you design studies depending upon...

The use of software to inform healthcare decisions is ubiquitous and is being utilized by patients, clinicians, and healthcare providers. Proper understanding, planning, and design of SaMD is essential for approval. ProRelix Research provides customized solutions and helps you adapt...

The success of a generic drug or biosimilar often hinges on the results of bioequivalence studies making it essential to partner with an experienced and reliable CRO to design and conduct bioequivalence studies. ProRelix Research offers full range service for...

ProRelix Research offers customized, end-to-end services for clinical trials of a broad range of biological products to help bring both innovator biologics and biosimilars to the market in a timely and cost-effective manner. We ensure compliance with regulatory requirements in...

The exponential growth in the natural product and dietary supplements field requires clinical trials to support safety and efficacy. ProRelix Research lends support at every step of your clinical trial journey to help you carve a niche in the dietary...

Diagnosis of diseases by clinicians using suitable tests guides treatment decisions and is necessary for improving and prolonging the health and well-being of patients. ProRelix Research partners with you to provide clinical trial support and ensure your device meets regulatory,...

ProRelix Research provides tailored end-to-end management of clinical trials keeping cost and patient safety at the forefront. We help you navigate the complex path of clinical trials by offering study support from patient recruitment to statistical interpretation to help you...

At ProRelix Research we understand that realization of the full potential of the emerging field of personalized medicine is dependent on the design and execution of clinical trials. We can help you circumvent the unique challenges associated with conducting precision...

ProRelix Research understands the utmost importance of protecting patient safety from clinical trials to real-world use of a new drug, biological or medical device. We help you develop appropriate pharmacovigilance plans and adverse event reporting systems in compliance with US...

Our experts at ProRelix research provide customized and comprehensive pharmacovigilance and safety monitoring programs in accordance with European Union (EU) regulations with an emphasis on patient well-being from research and development to post-market authorisation.

Patient safety and well-being lie at the heart of all our pharmacovigilance operations at ProRelix Research. We are with you every step of the way-from development of a pharmacovigilance system to regular reporting of safety and adverse events to regulatory...

How ProRelix Research can help you?

The successful execution and completion of a clinical trial are determined by several interconnected cross-functional expertise teams, including Medical Writing, Regulatory Affairs, Clinical Project Management, Clinical Data Management, Site Management, and Patient Recruitment,  Faster Ethics Committee Approval,  Pharmacovigilance, and much more.

A Quality driven Global Clinical Research Organization (CRO) that can truly understand your needs and help you to achieve your goals by minimizing the complexity across functional teams.  We at ProRelix Research strive to bring forth the best clinical research services managed by therapeutically sound experts and professionals who are having over a decade of international regulatory experience in conducting complex clinical trials into simple ones.

Also, our extensive knowledge, quality work, and global recognition make us an ideal choice for the rising demand for conducting holistic clinical trials which include New/ Repurposed  Pharmaceutical Products, Biological, Herbal, Nutraceutical, In Vitro Diagnostic Devices, Therapeutic Medical Devices, and more.

We are dedicated to follow the best ethical and clinical practices when conducting clinical studies while keeping the safety of all of our participant at core. Our motto is to provide our clients with prompt clinical study management, reliable clinical data with integrity, and ethical conduction of the clinical trials. The uniqueness of our services and functionality is that we not only design the ideal mechanism for better functionality of your trials but we also provide you a lending hand in all those processes and take you through them from the start till the end to reach your goal.

Our service portfolio includes Clinical Trial Project management, Phase 1 to 4 Clinical Trials, Drug Regulatory Affairs, Medical Writing, Clinical Data Management, Pharmacovigilance, Clinical Operations, etc . We are open to clients from all over the world and have a strong presence in USA and India and strategic partners in Europe, Australia. Let’s commit ourselves to better healthcare systems all around the world by ethical, prompt, and reliable clinical research studies!

Our  Highlights

• Clinical Research Organization with Global Services Capability in USA, India, Europe, and Australia
• Phase 1, 2, 3, and 4 clinical trial services for (i) Pharmaceutical (ii) Medical Device (iii) Herbal/ Neutraceutical
• Organized Structure and Reputation
• Experienced and  Best Service Portfolio
• Adaptability and Flexibility with Sponsor/Study Requirements
• Quality Assurance and Transparency

CRO Services

Clinical research services.

Our clinical research service focuses on the Quality, Ethics, and Well-being of the clinical trial subject… Read More

Data Management & Statistics Services

At ProRelix Research we are a team of experienced people who are well aware… Read More

Medical Writing Services

ProRelix Research’s medical writing service capabilities range from Clinical Research, Regulatory… Read More

Regulatory Affairs Services

ProRelix Research’s Regulatory Affairs services provide expert support in drug development programs. Read More

Recent Posts

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Clinical trials are undergoing a paradigm shift from a site-centric or traditional approach wherein the patients are required to go to central sites for consent processes, assessments, and safety monitoring […]

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Testimonials

I would highly recommend Prorelix Research as a client‐focused company with a strong patient database that delivers on its promise to deal with patient recruitment.

Global Pharma Company

We selected the Prorelix Research because of its comprehensive nature, flexibility and reliability. We were happy as ProRelix Research proved to be a best solution to our clinical trial operations .

Indian Pharma Company

We are very happy to have found Prorelix Research, during our relationship, ProRelix Research has delivered best services for our medical device study project..

Global Medical Device Company

The quality of the service provided by ProRelix Research matches the sophistication of their services platform. Their services have helped us thoroughly and promptly.

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The Leading Clinical Research Institute in Pune & India

Life -long partners in drug development.

Lifepoint is well known as the Best Clinical Research Institute in Pune & India . It has the best-in-the-class infrastructure for conducting clinical trials and a large and diverse therapy-naive patient pool to tap as well. We have well established research setup in 4500 square feet, which includes reception area, working station, Separate & access controlled pharmacy to meet all temperature needs (2 to 8 degree C, 15 to 25 degree C, -24 to -80 degree C), Monitoring rooms / Auditor Room/ Conference room. Research oriented qualified & experienced research Staff of 28 Study Coordinators, Site manager, quality manager, phlebotomists, Research Nurses & Other supporting staff.

Site has been inspected by:

• Local regulatory agency (DCGI) in May 2018 with no observations
• US FDA in June 2018 & July 2021 with no form 483
• WHO & AIFA in Dec 2019 with no major finding (we are now qualified site for WHO studies)
• In the last 7 years we have conducted 38 patient based bioequivalence studies, 90+ phase studies & 6 investigator initiated studies at this center in various indications.
• The Institutional Ethics Committee is Registered in CDSCO (ECR/751/INST/MH/2015/RR-21), also EC has been inspected for NABH.
• Site is registered with USFDA with FEI number- (3012051676) & (DUNS No. 650960482)
• Clinical laboratory is NABH & CAP certified & in the near vicinity with the turnaround time for getting reports 4 hours for Hematology & Biochemistry and within 24 hours for other tests.
• Management team having total domain experience of 13 Years and have successfully completed 400 plus trials with a variety of indications along with vaccine trials. We have closely worked with all the major domestic & Global Pharmaceutical companies .

Our Clinical Partners

We are ISO 9001:2015 Certified

Full Service SITE with phase 1, 2, 3, and 4 clinical trial services

Study Feasibility & Investigator Selection Site Qualification & Site Initiation visits Monitoring & Audit visits Correspondence with Ethics committee

Central/Local Lab logistics ICH GCP Trainings Site Closeouts

AE, SAE Reporting Completion of Paper/ e-CRFs and resolving Data Queries Document Maintenance, Updating & Retention

Assistance in ICF process Screening & Randomization of the subjects Subjects follow-up visits

Serving 15 Major Therapeutic Areas in Clinical Research

Gyn. & Obs.

Ophthalmology

Expert-Backed PG Diploma Program

The future of clinical research is bright and limitless. A PG Diploma Clinical Research Courses in Pune prepares students for careers in the healthcare field. In other words, this course provides the necessary skills and qualifications needed for the professional practice of Clinical Research Services in Pune. Students pursuing this course can make their career in the following:

• Healthcare and pharmaceuticals
• Nutrition and public health
• Bioinformatics, and drug designing
• Biomedical engineering
• Analytics,forensic sciences
• Food and beverages

Hear It From Our Students

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About Noble Hospital Research Center

We will provide you with the highest level of treatment!

Noble Hospital provides clinical research services for pharmaceutical and biotechnology product development from Phase I to Phase IV. Clinical trials must be scientifically conducted using appropriate methods based on strict observance of Good Clinical Practice and ethical considerations. This requirement places an increasingly heavy administrative burden on the medical institutions that perform clinical trials. A separate dedicated clinical research facility compliments the work of the investigators by providing them vital administrative and infrastructural support. Noble Hospital started its clinical research services in 2009. We have completed over 50 trials in various specialties and phases to date. Our team comprises Site Start-up specialists, QA manager and Clinical Research Coordinators (CRCs), headed by Dr. S. K. Raut, Director, Clinical Research.

Noble has the advantage of having efficient PI group Specialties in all major therapeutic areas like Oncology , Gynaecology, Cardiology, ENT, Ophthalmology, Orthopaedics, Dermatology, Gastroenterology, Urology & Nephrology.

The scope of our services includes

• Patient Screening and Recruitment : Our project management and study coordinators provide support to the investigators in the speedy recruitment of patients. A database of all patients admitted in the hospital and those availing out-patient facilities across the therapeutic area is maintained to aid in recruitment. This ensures that patients from various ethnic backgrounds and demographics are considered for the trial.
• Clinical Operations and Project Management : Our full-time staff of study co-ordinators ensures that the planning and execution of the clinical trials are smoothly managed from start to finish.

Clinical Research Facilities

• Dedicated space for clinical trials : Noble Hospital Clinical Research Department has a dedicated Space with 1200 sqft space within the hospital premises exclusively for conducting clinical trials. This includes clinics for consultants to see patients, sample collection room, data entry room, drug storage, conference hall and training hall facilities.
• State of the art drug storage : A separate fully automated temperature-controlled drug storage area for storage of the investigational product.
• Separate area for archival : A separate fire and water-resistant area has been made for archival of study documents.
• IT Infrastructure : Noble Hospital Clinical Research Department has a full-scale IT infrastructure with computers connected by LAN with a broadband connection to enable study coordinators to handle the data entry and data management requirements.
• Research Laboratory : We provide laboratory services for those sponsors who are interested in local labs instead of central labs.

Noble Hospital Institutional Ethics committee

Noble Hospital Institutional Ethics Committee (IEC) is approved by the Central Drugs Standard Control Organization (DCGI), under the Drugs and Cosmetics (Third Amendment) Rules 2013. Institutional Ethics Committee constituted as per ICH – GCP guidelines & Schedule – Y, has 11 members from various walks of life, with gender balance as per local statutory requirements. IEC meets every once in three months or whenever required and ensures that universal ethical values and international scientific standards are expressed in terms of local community values and customs. It especially has a focus to protect the safety, dignity, rights, and well-being of research participants.

The IEC attempts to ensure the protection of subjects by reviewing research protocols and related materials. The purpose of the IEC is to assure, both in advance and by periodic review, those appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. It promotes fully informed and voluntary participation by prospective subjects and seeks to maximize the safety of subjects. If required we seek expert opinion from various specialty and super specialty from our Hospital.

(DCGI Reg. NO. – ECR/259/Inst/MH/2013)

The Ethics committee is setup to ensure that the research protocols carried out:

• Are conducted according to the parameters of ICH–GCP as well as local regulatory requirements.
• Do not compromise the safety, rights and well being of the patients participating in the research study.
• Are conducted under the supervision of medical persons with the required experience/ expertise.
• Include solely patients who, through their legally acceptable representative have given informed consent for participation in the research study.
• The Committee can also be called upon to solve the ethical issues of the Noble Hospital on request.
• All Ethics Committee Members undergo a training program to update themselves about the current scenario in Clinical Research Also we send our Principal Investigators for ICH GCP Training programs.

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raptim research pvt. ltd.

Operating with the latest COVID-19 guidelines

Raptim Research Private Limited (formerly known as Raptim Research Limited), is a global independent and internationally accredited Contract Research Organization (CRO), established in 2005 with state-of-the-art clinical research facilities in Mumbai and Gandhinagar (India).

Our Services

• Healthy Subject (Bioequivalence & Bioavailability) Studies
• Patient Based Studies

In-Vitro Studies

• In-vitro Release Rate Test (IVRT) & In-vitro Permeability Test (IVPT)
• In-vitro binding Studies
• BCS Biowaiver Studies
• In-vitro Feeding Tube Studies

Special Studies

• In Vivo Tape Stripping
• In Vivo Dermal Microdialysis
• Skin Blanching studies
• Skin Irritation and sensitization test
• Glucose clamp Studies

Clinical Trials

• Early Phase Clinical Trials
• Phase II-IV Clinical Trial & Post marketing studies

We apply innovative tools and processes to our clinical development and support end-to-end services under the Clinical Research domain for all Global Pharmaceutical companies. With our experience and enhanced capabilities, we are in a unique position to assist our Sponsors with unparalleled support and provide them a single, global research network.

ASSAY LIBRARY

Your Trusted Partner in Bioanalytical Method Development and Validation

With a proven track record of excellence, Raptim Research Lab stands as a premier provider of bioanalytical method development and validation services. Having served leading pharmaceutical companies both in India and abroad, we take pride in our portfolio of over 500 validated methods.

Our expertise lies in delivering tailored solutions to meet the unique needs of our clients, ensuring accuracy, reliability, and regulatory compliance every step of the way. Whether it’s method development for new compounds or optimization of existing protocols, our team of experienced scientists is dedicated to delivering results that exceed expectations.

Partner with Raptim Research Lab and unlock the full potential of your pharmaceutical research endeavours.

At Raptim Research Pvt. Ltd., we are committed to ensuring patient safety while minimizing disruption and keeping studies on track during this evolving time.

Our sites in Navi Mumbai and Gandhinagar are following the protocols necessary to conduct studies with highest standards of care and safety:

• Social Distancing Protocols have been applied throughout our sites
• Volunteer Areas such as bedding facilities are kept at a distance
• Across the facilities, hand wash zones are marked, and sanitizers are available
• Training has been conducted on new anti Covid-19 measures implemented
• In association with clients and partners, modifications are being made to studies to reduce volunteer visits, avoid exposure to immunosuppressive drugs and monitoring safety of the patients at different time during the study
• Enhanced screening for all studies are being carried out
• Procured kits to conduct testing for Covid-19 at the diagnostic laboratory
• All subjects to be oriented for social distancing measures at the facility along with being given protective gear
• Minimum contact is practiced
• An isolation area is created to separate any subject with influenza like symptoms immediately

We are complying with the FDA guidance for conducting clinical trials.

read fda guidelines here

Standing in the gap between what is and what can be… Siro can help navigate and find answers that empowers lifesavers.

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Rediscover efficiency with our accurate solutioning and customer-focused approach.

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Since decades, Siro continues to deliver in the global healthcare industry. See the highlights of our journey here.

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World class therapeutic experts specializing across all niche therapeutic areas and indications.

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IVAAN is a Clinical Research Organization focussing on providing data parts of Submission package to FDA, Consulting Service of Data Standards from FDA, Data Standardization in CDISC (SDTM/ADAM) format, Data Management, Biostatistics and SAS programming services to pharmaceutical, health care, biotech and medical device industries.

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Associations.

On This Page

• The Genesis
• Competitive Advantage
• Mission & Vision
• USPs and Achievements
• Clinical Trials
• Investigator Initiated Research 
• Our Research Team

The Genesis:

• Sahyadri Hospitals are the largest chain of hospitals in Maharashtra. It is the brainchild of Dr. Charudutt Apte, one of India’s most renowned Neurosurgeons and more importantly an ardent practitioner of ethical medical practices.
• Sahyadri Clinical Research and Development Center was established in 2006.
• Sahyadri Clinical Research and Development Center & excels in coordinating a research driven team which has a well designed infrastructure with all modern amenities providing a milieu conducive to the advancement of professional and personal excellence.
• Experience of more than 500+ Clinical Research Trials in various therapeutic areas like Haematology, Oncology, Cardiology, Endocrinology, Infectious disease, Vaccines, Rheumatology, Gastroenterology etc.
• Well defined SOPs.
• Qualified and research oriented investigators of all specialties in Sahyadri Super Speciality Hospitals across Pune.

What Makes Sahyadri Clinical Research And Development Center Have A Competitive Advantage

• Sahyadri Clinical Research and Development Center (SCRDC) is a vertical of Sahyadri Hospitals Pvt. Ltd which is the largest chain of hospitals in Maharashtra.
• It is a renowned chain of secondary tertiary and quaternary care hospitals.
• SCRDC has dedicated, experienced, proactive Investigators with subject expertise.
• SCRDC has received NABH accreditation for Ethics Committee.
• Sahyadri Super Speciality hospital is NABH accredited.
• Sahyadri Hospital has a well equipped NABL accredited laboratory.
• SCRDC has successfully completed two USFDA & DCGI inspections.
• Sahyadri group offers a unique proposition for clinical research by its network that consists of 08 hospitals, 900 beds including 200 ICU beds, 2000 clinicians, 2600 supporting staff and over 27 years of experience. 50 lacs lives touched.

Certificates Of Accreditation

Our Mission Vision

• To safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected.
• To provide timely and high quality education, review and monitoring of human research studies.
• Medical care made available through accountable research.

Sahyadri Clinical Research and Development Center -USPs and Achievements:

• Institutional Ethics Committee has full accreditation of NABH.
• Previously accredited with international AAHRPP accreditation (Association for accreditation of Human Research protection program). We were the 4th site in India to receive this accreditation .
• Highest recruiting site for many studies.
• Sahyadri Hospitals Pvt. Ltd. Ethics Committee, Pune is registered under CDSCO with Reg. No. ECR/493/Inst/MH/2013/RR-19 valid upto Nov 2024 and it is accredited with NABH.
• Ethics Committee consisting of experienced members having passion for clinical research and ethics in general.
• Ethics Committee works as per The New Drugs and Clinical Trials Rules 2019, ICH-GCP, Schedule Y and ICMR guidelines & strictly adheres to approved Site SOP’s.
• Ethics Committee reviews and approves research activities with proper considerations of risks and anticipated benefits involving human participants.
• Ethics Committee has reviewed more than 500+ protocols.
• Ethics Committee committed to the safety of patients who take part in our trials, and uphold the highest ethical standards in all of our research initiatives.

Our Team of Ethics committee

Dr. ravindra ghooi.

Designation – Chairperson; Basic Scientist. Qualification – Phd. Medicine,M.Sc. Pharmacology.

Vast experience and expertise in Clinical Research for last 5 decades. Eminent member of various local, national and international research bodies.

Has wide knowledge and experience in teaching and training ethics in Clinical Research.

Dr. Deepa Divekar

Designation – Member Secretary; Clinician. Qualification – MD (Paediatric) Fellowship in Paediatric Neurology (London).

She is a Clinician and Pediatric Neurologist for more than 4 decades. Has a vast knowledge and expertise in research and ethics. She is associated with the hospital since its inception. She motivates and encourages her team members to be impartial and unbiased while making decision. She devotes adequate time to research and contribute largely to the quality of Ethics Committee decisions.

Dr. Mohini Barde

Designation – Clinical Pharmacologist. Qualification – MD Pharmacology.

Competent and knowledgeable Clinical Pharmacologist. Also provide consultancy to Biotech and Pharma companies. Very Resourceful with problem solving skills giving value addition in EC meetings.

Dr. Swati Sirsikar

Adv. Alka Patwardhan

Designation – Legal Expert. Qualification – LLM,LLB.

A school teacher and a advocate by profession for last 4 decades. Is very meticulous about the rights and safety of trial subjects. Takes a proactive approach when reviewing the clinical trial agreement, so that all the clauses pertaining to subjects’ rights are inclusive.

Dr. Swati Jadhav

Designation –  Basic Scientist / Ethicist. Qualification –  M Pharm, Phd Ethicist.

Has a Ph D in Bioethics in Clinical Research. Creative, enthusiastic health professional with 20 years’ experience pharma industry, academics, Clinical Research and Bioethics. Is very proactive with constructive participation in decision making a during EC meeting.

Mr. Trevor Martin

Mrs. Jayashree Jog

Designation – Lay Person. Qualification – Graduate in Nutrition.

Was actively involved in daily operation of family-initiated business. Nature lover, runs her own native plant nursery. Is a true representative of the community and always thinks and acts in a favor of research subjects. Contributor constructively to patient’s safety.

Adv. Dr. Deepa Paturkar

Designation – Legal Expert. Qualification – L.L.B, L.L.M. Ph D.

Vice principal and professor of law at ILS, Law college, Pune. Astute scholar, guide, researcher and academician with a rich experience of 3 decades in field of law spanning across college of repute. Advisor to corporates and hospitals on issues of ethics. Doctoral research in law relative to Human Organ Transplant. Her rich experience and expertise, contributes constructively to legal issues in Clinical Research.

Dr. Vaijayanti Kale

Collaborations

• Announcing alliance between Sahyadri Clinical Research and Development Center & Pfizer Ltd to push forward the research for future clinical trial developments.
• Sahyadri Clinical Research and Development Center has partnership with Sanofi Healthcare India Private Limited as preferred site in India.

Sponsors & CROs Associated with us 

• Sanofi Health care India Private limited 
• Paraxel International Clinical Research Pvt. Ltd.
• Boehringer Ingelheim
• JSS Research
• Dr. Reddy’s
• Reliance Life Sciences Pvt. Ltd.
• Celldex Therapeutics Pvt. Ltd.
• Sun Pharma Advanced Research Ltd.
• Cadila Healthcare Ltd.
• Glaxo Smithkline
• Johnson & Johnson
• Novonordisk
• Siro Clinpharm
• Manipal Accunova
• Semlar Research & Pvt. Ltd.
• Bristol Meyers Squibb
• Diagnosearch Life Sciences
• Lambda Therapeutics Ltd.
• Cangene Corporation
• Novartis Healthcare Pvt. Ltd.
• Novotech Clinical Research Pvt. LTd.
• Zydus Cadila
• Bharat Serum Pvt Ltd.
• Veeda Healthcare Pvt. Ltd.

Clinical Trials in Sahyadri Clinical Research and Development Center

Hematology trials.

• Haemophilia A & B
• Acute / Chronic myeloid leukaemia
• Invasive aspergillosis
• Multiple myeloma
• Patient with Factor VIII Inhibitor
• Hodgkin’s Lymphoma
• Myelodysplastic syndrome
• Afibrinogenemia
• Von Willebrand Disease

Oncology trials

• Ca Pancreas
• Ca Head & Neck
• Renal Cell carcinoma
• Glioblastoma Multiform
• Ca Colon /Rectum
• Urothelial Cancer

Neurology trials

• Multiple sclerosis
• Parkinson’s disease
• Fibromyalgia
• Paediatric Epilepsy
• Deep Vein Thrombosis
• Bariatric Surgery
• Stem Cell Transplant
• Hysterectomy
• Intra abdominal infections

Nephrology trials

• Chronic kidney disease
• IgA Nephropathy (IgAN)
• Erythropoiesis

Sahyadri Clinical Research And Development Center also conduct trial in different indication including Nephrology, Cardiology, Psychiatry, Internal Medicine, Gynecology, Dermatology, Urology, Orthopedic, Endocrinology, Paediatrics, Fertility Medicine etc.

Investigator Initiated Research

• Beside clinical trials Sahyadri Hospital Private limited conduct many in house trial, Research projects. 
• SHPL has an established Scientific Committee for valuable assistance in new R & D projects.
• Additional Biomedical and Health Research Committee (BHRC) to review Investigator Initiated Research. 
• This has added credibility and enhanced the research driven team of the institution.

You can contact us through

Our team of renowned principal investigator.

Dr. Shashikant Apte

Hematology & Bone Marrow

20 yrs in clinical research

Dr. Tushar Patil

10 yrs in clinical research

Dr. Shona Nag

20yrs of clinical experience

Dr. Uday Phadke

Endocrinology

15yrs of clinical research experience

Dr. Atul Sajgure

Dr. Suhas Hardas

Dr. Atul Joshi

Intensive Care and Medicine

Dr. Sheetal Mahajani

Gastroenterology

10 years in clinical research

Deccan , Pune

Plot No. 30-C, Erandvane, Karve Rd, Deccan Gymkhana, Pune – 411004

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Hadapsar, Pune

SN 163, Bhosale Garden Rd, beside Bhosale Nagar, Hadapsar, Pune 411028

Nagar Road, Pune

Near Hermes Heritage, Nagar Rd, Shastrinagar, Yerawada, Pune – 411006

Kothrud, Pune

Neena Co-op. Housing Society, Plot No. 9-B, Lokmanya Colony, Kothrud, Pune – 411038

Contact us:

Sahyadri Clinical Research and Development Center,

A Unit of Sahyadri Hospitals Private Ltd.

33/34B, Makarand Bhave Path, Erandwane, Pune-411004, Maharashtra, India.

Tel : +9120 6721 3120

E-mail id: [email protected]

c 2021, All Rights Reserved with Sahyadri Hospitals, Pune

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Life-changing therapies without a lifetime of development

No one who is working to help patients in need should be subjected to unnecessary delays during clinical development and commercialization. Precision’s integrated capabilities, responsive operations and deep scientific expertise are helping life science innovators accelerate research, development and manufacturing while reducing cost and increasing the probability of approval.

Specialized capabilities for every stage of clinical development

Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision brings a holistic view to your program's unique needs.

Global CRO Services

Award-winning CRO with deep oncology and rare disease expertise

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Exceptional translational and biomarker sciences with global central lab services

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Pioneers in planning, building and maintaining complex manufacturing facilities for biotech and pharma

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Precision for Medicine is a name and a movement

When our unusual name was chosen in 2012, it signaled our commitment to a new movement shaping medical innovation, a movement to bring precision to the development of novel treatments. Since our inception, we’ve brought precision to medicine with advanced biomarker capabilities, worldwide CRO services, technical manufacturing solutions and more. Unlike traditional approaches with scattered services, siloed expertise and ponderous processes, Precision has been purpose built to propel innovations to patients in need.

Optimize early phase development

How can you successfully navigate the complexities of early phase development? Integrated clinical and laboratory sciences capabilities are vital. Over 25 years of experience in early oncology development helps anticipate and mitigate a diverse set of risks, including complicated kitting and sample management.

Maximize late phase development

Congratulations if you are entering late phase development. Now you’ll need a partner that can recruit patients most likely to respond to treatment, manage complex protocols, anticipate global regulatory requirements, enable manufacturing, support commercial viability and more. Let us drive your innovation to market and empower access for patients.

Trusted partner to leading innovators in oncology and rare disease

Clinical development is growing more complicated. Progress can hinge on the ability to navigate a shifting pathway to approval. Your path may be unique from those who have gone before, but our experience will help inform success. Precision is a leader in oncology and rare disease research. Our deep experience in complex indications accelerates the ability to reach key milestones, drive positive outcomes and most importantly, help patients get access to innovative treatments.

Deep experience with debilitating disease and unique modalities

Like you, we understand that there’s a patient throughout the development pathway. Supporting our partners to bring innovative treatments to patients is our purpose. Leverage our experience in these therapeutic areas.

People first and patient-focused

One of our core values is service. Not just to our clients but to our communities. Volunteering at hospitals, supporting healthcare-related fund raisers and partnering with nonprofit organizations is an integral part of our culture. In doing so, we raise awareness of many life-altering diseases and our team gets closer to the actual patients that can be impacted by our work. 

Precision for Medicine has been a wonderful partner in trying to identify the right doctors, the right patients, and collect all the data that will be necessary to analyze, to be able to unequivocally answer the question of safety and dose

Their experienced and qualified staff displayed resiliency, creativity and innovation to keep things moving in the face of huge obstacles.

The conversion of manual Excel sample tracking to automated QuartzBio reporting resulted in 70% resource saving and shortened study and site close timeline by weeks.

I recognize that relations between Sponsors and CRO vendors can be strained and difficult, often a blaming game; this has never been my experience with this group as it truly felt like a partnership.

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We feel privileged to work in an industry that can change lives. When knowledge is shared, it is amplified. Expanding our collective intelligence can bring remedies to market faster. 

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Top 15 Contract Research Organizations (CROs) in 2024

Post-pandemic, as drug development businesses recover and grow, CROs around the world continue to undergo profound transformation. As in previous years, 2023 will be all about mergers and acquisitions, with big players getting even bigger and smaller companies surviving thanks to niche advantages such as technological know-how or brilliant scientists among their employees.

The top 15 CROs globally would be in the following order based on 2023 revenue :

• LabCorp (Covance) , with 15.05 billion USD (2023) and 75000 employees ( Labcorp , 2024).  In February 2015, Labcorp completes its $6 billion purchase of Covance, Inc., creating the world’s leading health care diagnostics company. The combination of Covance’s drug development leadership and Labcorp’s medical testing expertise builds the market leader in central laboratory and bioanalysis services. Labcorp’s clinical trials companies, Labcorp Clinical Trials and Tandem Laboratories, align under the Covance brand.  
• IQVIA , with 14.85 billion USD  (2023) and 86000 employees (IQVIA, 2022). IQVIA, formerly Quintiles and IMS Health, Inc., is an American Fortune 500 and S&P 500 multinational company serving the combined industries of health information technology and clinical research.  IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.  
• ICON (PRA) , with 7.74 billion USD (2022) and 41160 employees (ICON, 2023). From a small team of 5 people in 1990, ICON now employs over 41,100 people.  ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile  industry awards .  
• Thermo Fisher Scientific (PPD) , with 7.02 billion USD (2023) and 35000 employees (Businesswire, 2023). Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.  
• Lonza - 6.5 billion USD,   17896 employees. Though being a contract development and manufacturing organization (CDMO), rather than a CRO, takes the 10th position with the 5.9 billion USD in sales and over 17500 employees worldwide (2023), offering “proprietary line of in silico and in vitro services for manufacturability, immunogenicity, potency assessment, humanization and protein engineering” ( https://pharma.lonza.com , 2022). Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 17,500 full-time employees, it comprises high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The business benefits from global supply chains, but we have worked to maintain the agility to address marketplace needs on a local level. CDMOs become reliable partners for Pharma companies as their “services reduce R&D costs while improving productivity and are essential to providing safe and effective treatment to patients” ( https://pharma.lonza.com , 2022.  
• Wuxi AppTec with 5.8 billion USD revenue in 2021 and 44360 employees (Companiesmarketcap, 2022). As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."  

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.  

Cell and Gene Therapy CDMO Solutions has supported the development of 11 FDA approved cell and gene therapies and have conducted more than 900 studies in this field over the past year. Unsurpassed end-to-end offering results in enhanced access to scientific and regulatory expertise via multidisciplinary bench of experts to help you problem solve.   

Parexel (EQT Private Equity and Goldman Sachs Asset Management) with 3.8 billion USD in 2022 and 21000 employees (Parexel, 2023). Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.  

• Medpace Holdings, Inc. with 1.135 billion USD revenue in 2021 and 5400 employees (Medpace, 2023). Integrating core clinical trial services delivers efficient and streamlined execution and higher quality results. Through its wholly-owned subsidiaries, Medpace offers clinical pharmacology, as well as supporting laboratory services including central labs, bioanalytical lab, ECG core lab, and imaging core labs.  

Worldwide Clinical Trials – 0.6 billion USD , 3000 employees, 60 countries.

Worldwide Clinical Trials started out more than 30 years ago as a small science team with a big goal: To always provide authentic, personalized attention to our partners. And as the industry has grown, CROs have merged, and trials have grown increasingly complex, we haven’t forgotten what truly matters: People.

With more than 3,000 employees in more than 60 countries around the world, we’re still staying true to those roots. Our team is dedicated to staying accessible, flexible, and solution-focused to ensure our partners not only have the best possible outcomes – but they also know their Worldwide team is only a call away.  

Allucent (CATO SMS and Pharm-Olam) – 0.36 billion USD, 1200+ employees .

Allucent originated with CATO SMS, itself created by the merger of Cato Research and SMS-oncology in 2019. Cato Research, founded in 1988, was known for its ability to design and execute successful development strategies and guide creative new products through the regulatory process.

Previous acquisitions by CATO SMS included Array Biostatistics, a full-service biostatistical and statistical programming CRO, and Nuventra Pharma Sciences, one of the industry’s leading providers of clinical pharmacology science and services. With these acquisitions, CATO SMS expanded its services to offer biostatistical consulting, analysis, programming, and cutting-edge modeling and simulation techniques to inform clinical trial designs and predict trial outcomes.

In early 2022, CATO SMS merged with Pharm-Olam, a global clinical research organization delivering clinical trial services to organizations around the world.  

KCR – 0.15 billion USD, 700 employees  

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations.

Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting, and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, and Warsaw, Poland.

Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people.  

Advanced Clinical – 0.1 billion USD , 1100+ employees

Today, Advanced Clinical has grown organically, with coverage across North America, Eastern Europe, Western Europe and Asia-Pacific, providing contract research organization (CRO), FSP and strategic resourcing solutions. A research services and strategic resourcing organization committed to providing a better clinical experience by delivering comprehensive Contract Research Organization (CRO), Functional Service Provider (FSP) and Strategic Resourcing services that optimize effectiveness for both patients and sponsors throughout the clinical research journey.

Using our decades of experience, we strive to improve the lives of everyone touched by clinical research and help our clients achieve better outcomes through candid conversations, foresight, resilience and innovative solutions.  

CTI Clinical Trial and Consulting Services – 0.08 billion USD, 750 employees . CTI has grown consistently and significantly, becoming a global organization with associates in more than 60 countries across the world. We have worked on more than 10,000 projects, worked on every continent except Antarctica, and have contributed to more than 150 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Currently, we work with approximately 250 pharmaceutical and emerging biotechnology and medical device companies.

Among recent reasons for mergers and the whole new approach to conducting clinical research, apart from pursuit of new clients, talents, expertise, products, and markets, there have been notorious coronavirus crisis and military conflicts worldwide. We faced the advent of globalization, decentralization, remote monitoring, and personalized approach to drugs R&D. But we are now looking into the era of technology in clinical research. Processes that allow remote audits and monitoring, previously considered too risky, are now risk mitigators (Bahls, Christine, 2021), at least from that point of view. Clinical trial participants enrollment, and even participation itself, constantly moves into tech dimension.

Only few among the leading CROs escaped M&As for now, but this seems to be the matter of time. Savlovschi – Wicks, Theodora (2022) estimated that “in 2021, the global CRO market is expected to reach an impressive US$88 billion by 2028”. According to IQVIA , only in biopharma sector the total transaction value grew by 70% to reach 152 billion USD by the end of 2023, featuring prominent $43Bn Pfizer-Seagen deal, and other considerable M&As for BMS-Karuna ($14Bn), Merck-Prometheus ($10.2Bn), AbbVie-Immunogen ($10.1Bn), AbbVie-Cerevel ($8.7Bn), Biogen-Reata ($7.3Bn) and Roche-Telavant ($7.1Bn).

Among the CRO businesses the following M&As took place lately:

• Charles River Labs acquires  MPI Research (2018), Citoxlab (2019), HemaCare (2020) and Cognate BioServices (2021)
• IQVIA (formerly Quintiles and IMS Health) acquired Clintec and 40% of Q2 Solutions (2021)
• ICON purchased PRA Health Services (2021)
• Thermo Fisher Scientific bought PPD (2021)
• Labcorp purchased Covance and Chiltern
• Inotiv acquired Envigo (2021)
• INC Research and inVentiv Health merged to later become Syneos Health
• Parexel become the property of EQT Private Equity and Goldman Sachs Asset Management
• CATO SMS and Pharm-Olam merged in 2022
• Triley Bidco acquired Clinigen (2022)

The article by Nataliia Vietchinkina, MS in Clinical Research Administration

University of Liverpool. 

References:

• Christine Bahls (2021) ‘The Post-Pandemic CRO Landscape’, Applied Clinical Trials, Applied Clinical Trials-09-01-2021, Volume 30, Issue 9 [online] Available from: https://www.appliedclinicaltrialsonline.com/view/the-post-pandemic-cro-landscape
• Savlovschi – Wicks, Theodora (2022) ‘Top 10 CROs to watch in 2022’ [online]. Available from: https://www.proclinical.com/blogs/2022-3/top-10-cros-to-watch-in-2022
• Labcorp (2022) Labcorp Announces 2021 Fourth Quarter and Full-Year Results, 10 February 2022 [online]. Available from” https://ir.labcorp.com/news-releases/news-release-details/labcorp-announces-2021-fourth-quarter-and-full-year-results#:~:text=Revenue%20was%20%2416.12%20billion%20%2C%20an,by%20divestitures%20of%20(0.1%25)
• IQVIA (2022) IQVIA Reports Fourth-Quarter and Full-Year 2021 Results; Raises Full-Year 2022 Profit Guidance, 15 February 2022 [online]. Available from: https://ir.iqvia.com/press-releases/press-release-details/2022/IQVIA-Reports-Fourth-Quarter-and-Full-Year-2021-Results-Raises-Full-Year-2022-Profit-Guidance/default.aspx#:~:text=Revenue%20of%20%2413%2C874%20million%20for,12.4%20percent%20at%20constant%20currency
• ICON (2022) ICON Reports Fourth Quarter and Full Year 2021 Results, 2022 [online]. Available from: https://www.iconplc.com/news-events/press-releases/icon-reports-fourth-quarter-and-full-year-2021-results/
• Businesswire (2021) ‘PPD Reports Fourth Quarter and Full Year 2020 Results’, 23 February 2021 [online]. Available from: https://www.businesswire.com/news/home/20210223006094/en/PPD-Reports-Fourth-Quarter-and-Full-Year-2020-Results
• Macrotrends (2022) ‘Syneos Health Revenue 2012-2021 | SYNH’ [online]. Available from: https://www.macrotrends.net/stocks/charts/SYNH/syneos-health/revenue
• https://companiesmarketcap.com/ (2022) ‘Revenue for Charles River Laboratories (CRL)’ [online]. Available from: https://companiesmarketcap.com/charles-river-laboratories/revenue/
• Vinluan, Frank (2021) ‘CRO Parexel changes private equity hands again, this time for $8.5B’ [online]. Available from: https://medcitynews.com/2021/07/cro-parexel-changes-private-equity-hands-again-this-time-for-8-5b/
• Medpace (2021) ‘Medpace Holdings, Inc. Reports Third Quarter 2021 Results’ [online]. Available from: https://investor.medpace.com/news-releases/news-release-details/medpace-holdings-inc-reports-third-quarter-2021-results#:~:text=The%20Company%20forecasts%202021%20revenue,%24176.0%20million%20to%20%24180.0%20million%20 .
• Companiesmarketcap (2022) ‘Revenue for WuXi AppTec (2359.HK) Revenue in 2021 (TTM)’ [online]. Available from: https://companiesmarketcap.com/wuxi-apptec/revenue/
• https://pharma.lonza.com (2022) ‘Design, assess and optimize for clinical success’ [online]. Available from: https://pharma.lonza.com/offerings/early-development-services .

Clinical Research News

Upcoming clinical trials.

• Center for Innovative Public Health Research University of Miami; Ann and Robert H Lurie Childrens Hospital of Chicago Recruiting Testing a Gender-inclusive HIV Prevention Program HIV Prevention United States
• Takeda Not yet recruiting A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People (SPEAKUP) Hereditary Angioedema (HAE)
• Abbott Medical Devices Recruiting Abbott Structural Heart Device Registry (SH-Registry) Heart Diseases | Valvular Heart Disease | PFO - Patent Foramen Ovale | VSD - Muscular Ventricular Septal Defect | PIVSD - Post Infarct Muscular Ventricular Septal Defect | ASD - Atrial Septal Defect France, Germany
• Lisata Therapeutics, Inc. Not yet recruiting LSTA1 Phase 1b/2a Continuous Infusion Trial in mPDAC (FORTIFIDE) Pancreas Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | Pancreas Cancer | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Unresectable Pancreatic Cancer | PDAC | PDAC - Pancreatic Ductal Adenocarcinoma
• Yonsei University Recruiting ATezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma (ATBEST) Chemotherapy | Advanced Hepatocellular Carcinoma | Stereotactic Body Radiotherapy Korea, Republic of
• The First Affiliated Hospital with Nanjing Medical... Chinese Medical Association Not yet recruiting Effects of an Information-Based Discharge Service on Preterm Infants, Parents, and Hospitals Infant, Premature | Patient Discharge
• The First Affiliated Hospital with Nanjing Medical... Not yet recruiting Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer. Rectal Cancer
• Guangzhou Medical University Recruiting Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept Trial Pulmonary Nodule China
• The General Hospital of Western Theater Command Recruiting Clinical Study of Combined Platelet Transfusion Hematologic Diseases China
• Gerd Care Medical Ltd Recruiting Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms GERD (Gastroesophageal Reflux Disease) Israel
• Gazi University The Scientific and Technological Research Council of Turkey Recruiting The Effect of Mobile Application Use on Drug Administration Knowledge and Skill Level of Pediatric Nursing Students Nursing Caries | Nurse's Role Turkey
• Duke University Medical University of South Carolina; Eunice Kennedy Shriver National Institute... and other collaborators Not yet recruiting PK/PD of Digoxin in Infants With SVHD Infant, Newborn, Diseases | Infant, Premature, Diseases | Infant Conditions | Single-ventricle United States

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• QUALITY ASSURANCE UNIT (QAU)

QAU at PRADO works as “A defined system, including personnel who are independent of studies being conducted and are committed to assure test facility management for maintenance of compliance with the principles of Good Laboratory Practice”.

Welcome To PRADO, Preclinical Research and Development Organization Private Limited

Where We Are Dedicated To Providing Notch Services That Cater To Your Research Needs

What Is PRADO

PRADO, Preclinical Research and Development Organization Private Limited is one of the emerging, global, independent market leaders in providing preclinical services. Following services are provided by PRADO – Toxicity Testing ( In-Vitro and In-Vivo ), Development of Animal Models for Human Diseases, Pharmacokinetic Studies, Biocompatibility Studies and Pathology Services. Determination of the Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) of chemicals in compliance with EMA guidelines. Based at Pune India, PRADO is developing an outstanding reputation for providing excellent services and superior values. Our scientific data is of highest quality and our reports have excellent acceptance record with regulatory agencies, facilitating quick product registration and approval.

PRADO supports Pharmaceutical, Biopharma, Biotech, Medical Device, Pesticides and Agrochemicals, Food,Vaccine and Animal Health Industries by providing quality and cost effective preclinical services to meet their regulatory requirements. PRADO has all required technical expertise, research and development skills to provide excellent services. At PRADO, we understand how important in the on-time delivery for meeting the goals for regulatory submissions. We aim to work closely with our clients to understand their preclinical needs and develop program to meet their goals in timely manner. Thus, PRADO can be a strategic and scientific, yet responsive, flexible and trust worthy partner for your pre-clinical support.

Quality Policy

PRADO, Preclinical Research and Development Organization Private Limited is one of the emerging, global, independent market leaders in providing preclinical services. The following services are provided by PRADO – Toxicity Testing ( In-Vitro and In-Vivo ), Development of Animal Models for Human Diseases, Pharmacokinetic Studies, Biocompatibility Studies and Pathology Services. Determination of the Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) of chemicals in compliance with EMA guidelines. Based in Pune India, PRADO is developing an outstanding reputation for providing excellent services and superior values. Our scientific data is of the highest quality and our reports have excellent acceptance records with regulatory agencies, facilitating quick product registration and approval.   

PRADO supports Pharmaceutical, Biopharma, Biotech, Medical Devices, Pesticides and Agrochemicals, Food, Vaccine, and Animal Health Industries by providing quality and cost-effective preclinical services to meet their regulatory requirements. PRADO has all required technical expertise, research, and development skills to provide excellent services. At PRADO, we understand how important in the on-time delivery for meeting the goals for regulatory submissions. We aim to work closely with our clients to understand their preclinical needs and develop programs to meet their goals in a timely manner. Thus, PRADO can be a strategic and scientific, yet responsive, flexible, and trustworthy partner for your pre-clinical support.

Mission Statement

It is both our aspiration and commitment to place our values in everything we do to deliver the high quality integrated preclinical services building positive environment and sponsor satisfaction with achievement of safe and economic healthcare product development for mankind.

Our primary purpose and mission is to become a destination where all product development and registration for preclinical services available under one umbrella with international compliance to meet all our sponsor’s requirements.

We Build our reputation in preclinical excellence and wide scope speciality services at PRADO, we combine high quality research services at affordable cost. This is the reason why our sponsor’s have been entrusting values with us for their product development and registration work with confidence.

We are committed toquality as an internal part of our operations with the goal of achieving preclinical excellence and sponsor's satisfaction with consideration of safety by continuous improvement of our capabilities to identify, develop and provide services that adds value to our sponsors in Good Laboratory Practice in Preclinical Services.

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Services We Provide

Discovery and GLP Toxicity Studies. Acute, Subacute, Sub-chronic and Chronic Toxicity, Inhalation Toxicity, Genotoxicity Developmental and Reproductive Toxicity.

Clinical Pathology (Haematology, Clinical chemistry, Urine Analysis), Histopathology slide preparation and evaluation. Special Staining and Immunohistochemistry.

Pharmacokinetic

Pharmacokinetic and Tissue Distribution studies with single, multiple and cassette Dosing. Species- Rats, Mice, Rabbits, Pigs and Dogs (3 rd  party collaboration).

Genotoxicity

Reverse Mutation Assay (Ames Assay, Mini Ames), Micronucleus Test (MNT), Chromosomal Aberration Assay, Cytotoxicity Tests, Hemocompatibility,…

Development of animal model of human diseases. E.g. Inflammation and Pain, Metabolic Disorders, Antipsychotic Activity, Osteoporosis, Wound Healing…

Biocompatibility

The interaction between a medical device and the human body need to remain effective and safe over the lifetime of both the device as well as its recipient.

Service we provide

Pharmacokinetic and Tissue Distribution studies with single, multiple and cassette Dosing. Species- Rats, Mice, Rabbits, Pigs and Dogs (3rd party collaboration).

Reverse Mutation Assay (Ames Assay, Mini Ames), Micronucleus Test (MNT), Chromosomal Aberration Assay, Cytotoxicity Tests, Hemocompatibility,...

Development of animal model of human diseases. E.g. Inflammation and Pain, Metabolic Disorders, Antipsychotic Activity, Osteoporosis, Wound Healing...

Clinical Pathology (Haematology, Clinical chemistry, Urine Analysis), Histopathology slide preparation and evaluation. Special Staining and Immunohistochemistry

Development of animal model of human diseases. E.g. Inflammation and Pain, Metabolic Disorders, Antipsychotic Activity, Osteoporosis, Wound Healing or any other model as per sponsor requirement.

Reverse Mutation Assay (Ames Assay, Mini Ames), Micronucleus Test (MNT), Chromosomal Aberration Assay, Cytotoxicity Tests, Hemocompatibility, Device Implantation, Irritation studies.

Industries We Serve

PHARMACUETICAL

The pharmaceutical industry discovers, develops and market the pharmaceutical drugs for use as medications to be administered to patients.

Biopharmaceuticals and Biotechnology are becoming increasingly importantas novel and less toxic therapeutics for human disease.

The determination of the safety or biocompatibility of a device in a biological host environment is critical step in the development of an entire...

AGROCHEMICAL

At PRADO, we understand the need for accurate and reliable data for regulatory submissions such as those of the Central Insecticide Board.

Biopharmaceuticals and Biotechnology are becoming increasingly important in the development of novel and less toxic

Infectious diseases cause an overwhelming number of deaths around the world and their clinical management is often hampered by the emergence...

Stem cell therapy, also known as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using...

Risk Assessment

Setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities...

Food Biopharmaceuticals and Biotechnology are becoming increasingly important in the development of novel and less toxic Vaccine Infectious diseases cause an overwhelming number of deaths around the world and their clinical management is often hampered by the emergence... Stem Cell Stem cell therapy, also known as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using... Risk Assessment Setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities... PHARMACUETICAL The pharmaceutical industry discovers, develops and market the pharmaceutical drugs for use as medications to be administered to patients. BIO-PHARMA Biopharmaceuticals and Biotechnology are becoming increasingly importantas novel and less toxic therapeutics for human disease. Medical Devices The determination of the safety or biocompatibility of a device in a biological host environment is critical step in the development of an entire... AGROCHEMICAL At PRADO, we understand the need for accurate and reliable data for regulatory submissions such as those of the Central Insecticide Board. Facilities

Quality assurance unit, test item control office, in vitro facility, prado’s animal research facility (arf) has been designed to meet the global standards of conducting experiments on small laboratory animals. the arf has approvals from cpcsea, ministry of environment and forests, government of india. know more, the pathology department at prado, have specially designed laboratory areas for histopathology and clinical pathology. a spacious necropsy room is available for blood collection, plasma separation, conduct of gross pathology examination, organ weights and organ collection. know more, at prado, quality assurance unit (qau) is separate department, established in accordance with the requirements of oecd principles of glp. qau conducts, study based, facility based and process-based inspections, as per the standard operating procedures (sops). know more, at prado, a designated, glp compliant test item control office (tico) is present. the tico area is separated based on different types of test items such as pharmaceutical, biopharmaceutical, stem cells, medical devices and agrochemical etc. know more, prado understands its corporate- social responsibility, towards this prado has established solar system to save the electricity and making use of natural renewable energy. for processing of facility waste, bio-digester system has been in place. know more, the safe and secure storage of the facility and study related data and material is required for oecd principles of glp. prado has suitably designed and constructed separate wet and dry archives. availability of ample space within the archives to accommodate archived records and material. archiving procedure are ensured through strict compliance with sops. know more, the in-vitro laboratories at prado are spread over 600 sqft and are designed for carrying out genotoxicity and biocompatibility studies, including cytotoxicity studies. know more.

PRADO’s Animal Research Facility (ARF) has been designed to meet the global standards of conducting experiments on small laboratory animals. The ARF has approvals from CPCSEA, Ministry of Environment and Forests, Government of India

The Pathology department at PRADO, have specially designed laboratory areas for histopathology and clinical pathology. A spacious necropsy room is available for blood collection, plasma separation, conduct of gross pathology examination, organ weights and organ collection.

At PRADO, Quality Assurance Unit (QAU) is separate department, established in accordance with the requirements of OECD principles of GLP. QAU conducts, study based, facility based and process-based inspections, as per the standard operating procedures (SOPs).

At PRADO, a designated, GLP compliant Test Item Control Office (TICO) is present. The TICO area is separated based on different types of test items such as pharmaceutical, biopharmaceutical, stem cells, medical devices and agrochemical etc.

PRADO understands its Corporate- social responsibility, towards this PRADO has established solar system to save the electricity and making use of natural renewable energy. For processing of facility waste, bio-digester system has been in place. 

The safe and secure storage of the facility and study related data and material is required for OECD principles of GLP. PRADO has suitably designed and constructed separate Wet and Dry Archives. Availability of ample space within the archives to accommodate archived records and material. Archiving procedure are ensured through strict compliance with SOPs.

The in-vitro laboratories at PRADO are spread over 600 sqft and are designed for carrying out genotoxicity and biocompatibility studies, including cytotoxicity studies.

Certification & Awards

• PRADO received recognition by DSIR (Department Of Scientific & Industrial Research,Govt. Of India).
• PRADO has successfully received GLP certificate at our new location. Certificate No:GLP/C-168/2021
• We have successfully completed the relocation inspection of our Test Facility by NGCMA.
• PRADO received GLP certification at previous location - Certificate No: GLP/C-127/2018. We have relocated our test facility, awaiting renewal of GLP certificate.
• PRADO Received 'Fastest Growing Indian Company Excellence Award 2017' by International Achievers Conference at Bangkok, Thailand.
• Our CEO and Director received 'Indian Leadership Award for Industrial Development' from All India Achievers Foundation in 2017.
• Received CPCSEA certificate (1723/PO/RcBiBt/13/CPCSEA). Our new facility has also been inspected and approved by CPCSEA.

Certification & Awards

Our team members.

Dr. Pralhad Wangikar

Director and CEO

Ms. Ila Wangikar

Managing Director

Dr. Pradeep Deshmukh

Deputy Test Facility Management

• Phone: +1 (859) 254-6589
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Awarded as “ best institute for clinical research in india ” in asia education summit & awards in 2017, certified as iso 9001:2015 company in 2016, “ certificate of commitment ” issued by central vigilance commission of india in 2016, agreements signed with multiple companies in uk, south africa, usa and malaysia for clinical research development segment in 2015-17, sister concern brand of prorelix research since 2017.

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