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.