A CUSTOM OF INNOVATION IN CLINICAL RESEARCH
Will always have a high moral values towards the Commitment of work like Documentation and Maintenance and will always Concentrate on Safety & Efficacy of all Research Participants.
Will help to get new protocols from Clinical trial vendors of Phase studies, Instrumentation studies, ICMR based studies, BABE studies etc., and will support with proper consultation and Legal opinion in confirmation of Clinical Trial Agreement with the sponsor.
Institution staffs like Principal Investigator, Co- Investigator, Sub – Investigator, Study Coordinator & other study team members will be given GCP training adequately along
Will coordinate with the Site Team for activities like Study Feasibility, Site Selection, Study Initiation, Recruitment Status, Safety & Follow-up, Study Completion and Study Close Out and will guide the INSTITUTION for timely preparation of documents in case of Audits from USFDI, DCGI, IEC, Sponsor & CRO.
Will ensure and focus on Quality of Data , Recruitment strategy, Patient Screening, Patient assessment, EDC Entry, Protocol Compliance and Patient Safety.