Analysis and Reporting
The culmination of a clinical trial is the analysis of the data that will determine whether the safety and efficacy of the treatment has been proven. Technologies that ensure analyzable data is available soon after input data is verified have direct impact on a trial's length—and are a key determinant of overall drug development time.
Medidata Rave®, a single EDC/CDMS system with user-friendly electronic data collection and robust data management capabilities, is today powering shorter development times and earlier visibility to clean, analyzable data for cutting edge life science companies. SAS data sets can be produced directly from Rave on demand. Development time can also be shortened by having the initial protocol document, which contains the data set's structural elements that will be required by the biostatistics department, inform the final analytic database through Medidata Designer®.
Medidata Rave reporting solutions span the key requirements during a trial for both clinical and trial performance data, as used by data managers, sites, monitors and trial executives. Clinical data reports allow study teams and investigator sites to track subject and site compliance and validate data query and follow-ups. Trial performance reports help identify bottlenecks and track performance issues throughout a trial's duration. Standard reports, custom reports and ad hoc reporting tools meet various requirements of users, and the ability to provide a variety of reporting tools is key to meeting individual sponsor requirements.
Medidata Rave functionality also addresses the submission process, with automated preparation of the documentation from the EDC system through tools such as the PDF generator.