KPSCS staff composed of highly qualified and experienced professionals who manage all aspects of Phase II-IV Clinical trials including: Project management, Study conduct and monitoring, Volunteer screening, Medical writing, Bio-analytical evaluation, Data Management & Statistics, Quality Assurance through following activities given below.
- Development of Protocol, ICD, CRF and Investigator brochure.
- Investigator selection and finalization.
- Getting ethics committee’s approval.
- Coding, and dispensing of samples to investigators.
- Co-ordination with the investigators for patient enrollment.
- Responsibility for successful completion of clinical trials.
- Analysing and preparation of clinical study reports.
- Responding to regulatory agency’s request for information pertaining to product safety.
|