Training and Development  
Preclinical Study Center  
 Bioequivalence Study Centre  
Regulatory Affairs
Investigator Registration  
PHASE II-IV CLINICAL TRIALS
 

KPSCS staff comprise 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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