TRAINING ON CLINICAL RESEARCH,CDM,SDTM,SAS WITH PROJECTS IN IN INDIA

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.