Clinical Trial Centre

The Clinical Trial Centre has been established with the primary objective of conducting high-quality clinical research to support the development of new drugs on 11 October 2022. This initiative aims to contribute significantly to medical advancements by ensuring the safety and efficacy of new treatments before they reach the market. The inauguration ceremony was marked by a formal ribbon-cutting and Nariyal Fodne ritual, symbolizing new beginnings and success. The event was graced by the Honourable Vice Chancellor of SRHU, Dr Vijay Dhasmana, along with Dr Rajendra Dobhal, Director, Strategies Planning, Research & Development, SRHU, emphasizing the institution’s commitment to fostering research excellence in clinical trials. Clinical trials in India involve systematic testing of new drugs, therapies, and medical interventions on human participants to evaluate their safety, efficacy, and potential side effects. These trials are conducted under strict regulatory frameworks, including the New Drugs and Clinical Trials Rules (NDCTR) 2019, Indian Council of Medical Research (ICMR) Guidelines, and Drugs Controller General of India (DCGI) regulations. As per government mandates, all clinical trials must be registered in the Clinical Trials Registry - India (CTRI) before initiation, ensuring transparency and adherence to ethical research standards. Dr Nikku Yadav assured that all clinical trials conducted at the center will strictly comply with national and international regulatory requirements. No study will proceed without obtaining necessary approvals from DCGI and oversight from an independent Institutional Ethics Committee (IEC) to uphold ethical standards. To enhance the efficiency of clinical trial operations, the center has partnered with Somaya Research and Health Services (SRHS) LLP, a distinguished Site Management Organization (SMO), as well as KV Clinical Research, Chhattisgarh, to expand research capabilities and ensure streamlined operations. These partnerships will facilitate patient recruitment, regulatory compliance, and data management while strengthening multi-center clinical trials across different locations. The center will conduct clinical trials for multiple therapeutic indications, including cardiovascular diseases, metabolic disorders such as diabetes and PCOS, neurological disorders like Alzheimer’s and epilepsy, infectious diseases, oncology, and rare/orphan diseases. Our team of experienced clinicians and researchers will actively contribute to drug development, bringing new treatments closer to clinical application.

A key focus of the center is to provide hands-on training to students enrolled in the Clinical Research program, equipping them with practical experience in clinical trial management. Under expert supervision, students will be trained in protocol development, regulatory submissions, patient recruitment, informed consent processes, data collection, monitoring, adverse event reporting, and pharmacovigilance. This real-world exposure will enhance their skills and prepare them for careers in the pharmaceutical, biotechnology, and healthcare industries.

Before initiating any clinical trial, the center will obtain approvals from DCGI, IEC, and other regulatory authorities to ensure compliance with ethical guidelines. Patient rights, confidentiality, and informed consent will be strictly upheld throughout the research process. The establishment of this clinical trial center marks a significant step in advancing medical research and drug development in India. Through regulatory compliance, collaboration, and a commitment to ethical research, the center aims to contribute to the discovery of innovative treatments that improve patient care. Furthermore, by integrating research with education, the center will provide invaluable training opportunities for students, strengthening the future workforce in clinical research.