Clinical trials are more complex and global in nature. This makes it challenging for sponsors and CROs to ensure that all sites in the trial have completed the required training modules (including new staff who join the trial mid-stream).
A proper training on GCP Clinical Trial Management Systems (CTMS) is necessary for successful trials. The current trend is moving towards a worldwide harmonization of Quality and Safety with Customer and Business requirements. Whether its a manufacturer or a supplier to the Pharmaceutical/Medical Device/Biotechnology Industry, a business expansion, continual Improvements and customer satisfaction rests principally on it.
Regulatory consultants provides general, targeted, and individually-designed approach and step-by-step instructions for a project initiation and high-quality implementation from Feasibility to Clinical Study Report Development; from Drug Safety Monitoring System establishment to Individual Case Safety Report (ICSR) Forms completion.
Contract Research organization (CRO’s), providing various services to pharmaceutical Industry are well established all over the world and are on a expansion mode in India. CRO’s are specialized in fields such as: Pre-Clinical ( Toxicology& Pharmacology), bioequivalence, Clinical and Pharmacokinetics, Clinical Trials ( Phase I-IV), Data Management, Formulation Development, Analytical Development and Regulatory Support .
Training is essential to ensure the competence of the platform for quality research, and for that reason it is structured in two levels: Internal training: To ensure that every member of personnel in company is properly trained, by means of the corresponding training plan. External training: To assist in the training of health professionals in the methodological, ethical and legal aspects of clinical research.
Most of the trainings provided by regulatory consultancies offer Scientific and technical advice, Development advice for study proposals, Advice for study fund-finding, Advice in the planning and, implementation of pharmacovigilance plans, Advice on scientific/medical writing of protocols.