Safety Clinical Development
Clinical group is involved in conducting Clinical Trials of candidate drugs developed at CDRI, Lucknow. This includes undertaking responsibilities of a Sponsor i.e.
➤ Plan and Protocol for Phase I, II and III Clinical Trials
➤ Case record forms (CRF)
➤ IND applications
➤ Clinical study/trial reports
➤ New drug application (NDA)
➤ Investigators Brochures (IB)
➤ Informed consent forms
➤ Ethics Committee document preparation
➤ ADR/AE reports
Interaction with Pharmaceutical Industries for
Joint Collaboration
Commercialization of approved products
ADR and Pharmacovigilance
➤ Selection of Clinical Trial Centers/Investigators
➤ Conduct/organize Investigator meetings
➤ Clinical Trial Monitoring
➤ Setting up to DSMB
Interaction with Regulatory Agencies
Drugs Controller General (India)
Institutional Ethics Committees
Independent Drug Monitoring Committees (IDMCs)
Clinical Trials being multi-Institutional activities, the Clinical Trial group has been collaborating with various Institutions/Organizations for conducting Clinical Trials as per Schedule “Y” (Drugs and Cosmetics (IInd Amendment) Rules, 2005) and GCP guidelines. CDRI has been collaborating with Clinical Pharmacology Unit at Seth G.S. Medical College & KEM Hospitals Mumbai and Clinical Pharmacology Unit, PGIMER, Chandigarh for Phase I Clinical Trials of CDRI candidate drugs. Phase II and III Clinical Trials involve collaboration with various Medical Institutions of India like CSM Medical University (erstwhile K.G’s Medical College), Lucknow; SGPGI, Lucknow; PGIMER, Chandigarh; AIIMS, New Delhi; Seth G.S. Medical College, Mumbai; IMS BHU, Varanasi; Gandhi Medical College Bhopal; Army Hospital, New Delhi and Srinagar; SMS Medical College, Jaipur to name a few.
Clinical group has made major contribution in the various drugs marketed by CDRI and presently a number of promising candidate drugs are in various phases of clinical developed.