Clinical Study Reports (phases I to IV), compliant with ICH E3 standards
• CSRs are the key means by which regulators can assess the outcome of clinical studies.
• ClinScript’s long experience in writing many 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 CTD/eCTDs.