Clinical Study Report (CSR)

  • CSRs are the key means by which regulators can assess the outcome of clinical studies. Their format and content are defined in ICH E3.
  • CSRs also include Clinical Trial Reports – the new EU terminology for CSRs when the study report pertains to an interventional (rather than non-interventional) clinical trial.
  • Trilogy’s long experience in writing hundreds of CSRs for all phases of clinical development and across most indications helps our clients to crystallize the essential results that regulators need to know.
  • We work closely with clients to meet the challenge of the large numbers of complex subject narratives often required for CSRs.
  • The CSRs we prepare optimize and streamline the preparation of ensuing CTDs.
Trilogy Services