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Clinical trial design & documentation

We offer clinical trial design services from concept to report.Our experts take up preparation of all types of documents pertaining to a clinical study,pre-submission proposal to post-clinical research reports and appendices according to the ICH guidelines.

Pre-submission
  • Clinical study protocol
  • Investigator brochures
  • Patient informed consent forms

Post-submission
  • Clinical study report(CSR)
  • Summary of safety and efficacy
  • Phase integrated clinical statistical reports