Clinical Study Report (CSR) is lengthy and manually written document which discusses about the Clinical Trial methods and results. Authoring this document consumes more manual effort. The source documents such as Protocol, Statistical Analysis Plan (SAP), Case Report Form (CRF), Safety Narratives, In-text tables, Tables, Listings and Figures (TLFs) contribute considerable amount of information to the CSR.
The tool automatically extract and collates information from sources document such as protocol, SAP, In-text etc., in the appropriate sections as per ICH E3 guidelines for CSR. The tool automates significant effort of the medical writers. The tool also has the workflow & dashboard module which can be configured as per the sponsor needs.
The system is designed to generate pre-filled CSR with information from Protocol, SAP and other sources as per ICH-E3 guidelines in the respective and system well interpret some of the study resortes sections which could save medical writers 60%-70% of time.
Medical writers can focus more on interpretation of study results and their discussion points.
In workflow integration, system can be configure as per the sponsor's needs.