Clinical trials have become the established modality for understanding the efficacy and safety of novel drugs, vaccines and devices. In order to perform robust clinical trials, it is imperative that suitable infrastructure and platform is created for the same. The Clinical Trials & Research Unit was established at SRM Medical College Hospital in 2012. The purpose of the unit was to develop a Centre of Excellence for conducting academic and regulatory clinical trials. These facilities conform to international standards and regulations such as guidelines and the Drugs & Cosmetic Act, New Drugs and Clinical Trial Rules applicable to clinical research practice.
Clinical Trials and Research Unit (CTRU) offers sponsors and investigators the support they need to conduct clinical trials and research.
The Clinical trial unit consists of a space of approximately 7500 square feet that is exclusively devoted for trial activities. The unit consists of a reception, counseling room, sample collection room, sample processing and storage room, data documentation room, a ward which can accommodate 10 beds, IP storage room, investigators room and archival room. The entire unit is centrally air conditioned and has 24 X 7 UPS back up. In addition, essential equipment for performing clinical trials such as computers with internet connection, printer, scanner, copier, centrifuge, cooling centrifuge, thermohygrometer, deep freezer, refrigerator, pipettes and autoclave are in place. The intensive care unit isclosely located to the clinical trial unit.
The CTRU of SRM MCH & RC is a centralized, shared research resources which provide access to instruments, technologies, testing and services. The unit provide expert technical and consultative services to investigators engaged in basic science research and clinical trials.
There is dedicated man power for managing the clinical trial unit which includes Pharmacologist, Clinical Pharmacologist, Research Associate, Clinical Research Coordinators, Research Nurses, Pharmacists, Lab Technicians, Data entry Operators, Office Assistants and Patient Attenders. Besides this, there are also investigators from various clinical departments closely working with the trial unit for different indications. All of the staffs are well trained in Good Clinical Practice in clinical research on an annual basis and are experienced in managing several regulatory/academicclinical trials. All the staffs are uniquely trained to carry out research protocols with an emphasis on patient safety and research quality.
Since 2012, the department has been involved in several regulatory and academic clinical trials which span various disciplines such as general medicine, surgery, obstetrics & gynecology, pediatrics, pulmonary medicine, cardiology, critical care. Several trials have been performed in vaccines including the prestigious COVAXIN trials in all 3 phases, Rotavirus vaccine, pentavalent vaccine, meningococcal vaccine as well as long term cardiovascular outcome studies such as ODYSSEY and TIPS3. There is also a CDSCO registered ethics committee that supervises and reviews all clinical trials that are performed by the trial unit. The trial unit has also faced regulatory inspection from CDSCO authorities successfully. The trial unit was constructed by SRMIST in collaboration with a research grant received by IIISM Dept from DST, Govt of India amounting to 14 crores. The unit has received several grants from both Govt agencies such as ICMR, BIRAC and several other pharmaceutical industry sponsors.