Clinical Study Report (CSR), SYNOPSIS AND ADDENDUM

Clinical study reports serve as the primary instrument through which regulatory bodies evaluate the results of clinical trials. In ICH E3, their structure and content are detailed. 

Clinical trial reports are a different title given to clinical study reports that pertain to an interventional clinical trial as opposed to a non-interventional one. This is the terminology used by the European Union for such reports. 

Our extensive background in composing clinical study reports for hundreds of clients spanning all stages of clinical development and the majority of indications enables D L Global Services to assist our clients in demonstrating the crucial findings that regulators require. 

Our clinical study reports facilitate and optimize the process of generating subsequent clinical trial dossiers.