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PHASE II-IV CLINICAL TRIALS
 

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.


 
 
 
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