Data management functions in clinical trials—extensive data cleaning, full query management, protocol deviation management, batch processing, as examples—have traditionally been served by stand-alone clinical data management systems (CDMS), whose input is from paper forms or from separate electronic data capture systems. Distinct electronic data capture and data management systems require data integration, with resulting timing and reconciliation issues.
A new type of EDC system has emerged that handles not only data collection functions but robust functionality in data management, once only the province of stand-alone CDMS. The development of this modern EDC/CDMS system reduces error-prone data reconciliation issues and allows faster, real-time access to clean clinical data.
Medidata Rave®, a single system EDC/CDMS, not only provides the full range of data collection and robust data management tools sponsors expect, but, because it is a single system, can offer new capabilities: local, instantaneous translation into multiple languages, including double byte character sets such as Japanese and Chinese; paper data collection directly into the EDC system; protocol deviation identification and management; source data verification integrated with data management, and more.