Site Experience

While paper processes have plagued the workflow of site coordinators and investigators for years, study teams have not been quick to adopt early electronic data capture (EDC) technologies, in part because those early EDC systems had not been designed to bring value to the sites themselves. Medidata Rave, however, has been designed by investigators and clinical coordinators to provide research efficiencies to study teams without disrupting daily clinical activities.

The simplicity of Medidata Rave makes it easy for investigators and clinical coordinators to adopt Medidata Solutions' tools for the capture of clinical data—a critical factor for the success of any clinical trial. Medidata Rave's intuitive user interface allows for the tracking of subjects, case report forms and time-based tasks, allowing sites to both manage data entry and query resolution, as well as their own visit workflows.

As a truly thin-client solution, Medidata Rave enables investigator sites to use computer systems already in place without having to involve IT departments to make server or firewall adjustments. The technology also simplifies maintenance of regulatory responsibilities for investigator sites through comprehensive easy-to-use audit trails and compliance with 21 CFR Part 11 requirements.

Medidata has also created an eLearning capability that allows sites to receive instruction from their computers, at their own pace. Once training is completed satisfactorily, the site can enter the study and begin to enter data.