Clinical Trial

The Clinical Trials Department at (MDRF) is led by Dr S. Poongothai, who brings over 33 years of distinguished experience in clinical research. With specialised expertise in the design, conduct, and oversight of global Phase II–IV clinical trials, she has supervised 168 international studies while ensuring the highest standards of ethical conduct, regulatory compliance, and scientific rigour. Dr Poongothai has collaborated with leading multinational pharmaceutical companies—including Novo Nordisk, Novartis, Pfizer, GSK, Boehringer Ingelheim, Takeda, Eli Lilly, Bristol Myers Squibb, Roche, PPD, Bayer, and Sanofi-Aventis—and has served as Study Manager for landmark trials such as SOUL, DREAM, ADVANCE, ORIGIN, and EPI-DREAM. Her extensive training includes advanced GCP certification in Singapore, clinical research training at the University of Alabama, translational research at the CDC in Atlanta, and regulatory training at CMC, Vellore.

Vision

World-class infrastructure supporting ICH-GCP compliant clinical research. Nationally recognized resource center with globally acknowledged expertise. Proven excellence in clinical trial design, execution, data analysis, and reporting. Unwavering commitment to ethical, high-quality, and impactful research.

Mission

Our mission is to generate reliable, ethical, and scientifically robust evidence to improve patient outcomes. We are dedicated to evaluating the safety, efficacy, and real-world impact of novel treatments, diagnostics, and interventions. Our goal is to ensure that medical advancements are not only innovative but also rigorously tested, trustworthy, and accessible. At our core, we are committed to safeguarding patient well-being, advancing medical innovation, and enabling informed, evidence-based decision-making in healthcare.

As Head of the Department, Dr Poongothai has played a pivotal role in strengthening MDRF’s clinical trial infrastructure by ensuring protocol adherence, regulatory readiness, and operational excellence. She has successfully guided the organisation through audits by EMEA, DCGI, and numerous international sponsors. A respected speaker at national and international conferences, she is widely recognised for her expertise in research ethics, protocol development, informed consent, safety reporting, and participant retention. With over 50 peer-reviewed publications exploring depression, impaired glucose tolerance, diabetes, and its complications, she has made significant academic contributions. Her achievements include the Best Poster Presentation Award for participant retention and the Ahuja Award for her work on depression and diabetes. Her invited lectures at institutions such as Duke University, Sanofi-Aventis, and Novo Nordisk further highlight her leadership in advancing India’s clinical trial landscape, while her record of achieving 100% follow-up across more than 168 trials underscores her exceptional professional commitment.

Dr. S. Poongothai

Activities of the Department

Our department has successfully completed 168 national and international clinical trials, all in full compliance with Good Clinical Practice (GCP) guidelines. With a screen failure rate of less than 5%, we take pride in our meticulous approach to trial conduct, reflecting our strong adherence to protocols and thorough understanding of GCP principles.
Our exceptionally low dropout rate highlights the dedication and commitment of our clinical trial team. We ensure consistent patient follow-up through to the completion of each study, achieving a 100% follow-up rate in over 165 trials. Our staff are extensively trained in effective patient engagement, facilitating smooth trial execution and fostering strong rapport with participants. These strengths have positioned MDRF as a recognized nodal center for several pharmaceutical companies.
The team ensures consistent patient follow-ups until the completion of each study. Staff are trained in effective patient engagement, facilitating smooth trial processes and rapport-building. We have track record of 100% follow-up in more than 165 studies. These strengths have helped MDRF gain recognition as a nodal centre by many pharmaceutical companies.
Our department has undergone over 28 external audits which includes EMA, DCGI and assess GCP compliance and protocol adherence, reinforcing our confidence in maintaining high standards

Key Responsibilities in Clinical Study Execution

Clinical Study Execution

Ensure rigorous adherence to approved study protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements throughout the trial lifecycle.

Audio-Visual Informed Consent

Obtain valid, voluntary, and informed consent—including audio-visual documentation where required—ensuring full compliance with ethical, legal, and regulatory standards.

Participant Safety & Medical Oversight

Oversee the medical care, safety, and well-being of all study participants, ensuring timely clinical assessments and interventions as needed

Regulatory & Ethics Communication

Secure all necessary regulatory and ethics approvals. Maintain proactive, ongoing communication with Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory authorities

Adverse Event Reporting

Identify, document, and report Adverse Events (AEs) and Serious Adverse Events (SAEs) within regulatory timelines and as per sponsor requirements, ensuring thorough documentation and follow-up.

Protocol & Process Compliance

Develop and implement systems to ensure consistent compliance with study protocols, standard operating procedures (SOPs), and trial-related administrative requirements

Trial Monitoring & Issue Resolution

Conduct regular monitoring of study progress. Identify and address protocol deviations, operational challenges, and quality issues in a timely and effective manner.

Financial Management

Oversee trial budgeting, expenditure tracking, and financial reporting to ensure accurate and responsible use of funds in alignment with sponsor agreements.

Data Management & Reporting

Collaborate with data management teams to ensure accurate data collection, validation, and analysis. Support timely reporting, publication, and regulatory submission of study results in compliance with ethical standards

AWARD

Certificate of appreciation received from NOVO NORDISK during “Clinical Research Coordinator” meeting held on 14th & 15th December 2025

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