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.