Clinical Trial Documentation

High Quality Documentation is an important and integral part of clinical research, especially essential for the successful launch of new drug/molecule formulation. Very often, companies have failed to get approvals for their clinical trials because of poor or faulty documentation.

Right from pre-clinical studies to post marketing periodic safety update reports, accurate documentation is involved in every step, and helps to facilitate the planning, execution and tracking of relevant clinical trial activities.

We can provide documentation services to develop key documents that are critical in clinical trial management, as follows

  • Study protocol
  • Case Report Form (CRF)
  • Statistical Analysis Plan (SAP)
  • Report and Analysis Plan (RAP)
  • Clinical Study Report (CSR)

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