Medidata Rave®

Capturing Data | Managing Data | Reporting Data | Building Studies |  Safety

Building Studies

Enable research teams to independently build studies

Medidata Rave's study build tool, Architect, features a complete set of capabilities designed to allow study teams with research and data management backgrounds, not programming expertise build and deploy studies without the need to hand off to programming professionals. Architect's powerful capabilities help reduce the time and effort spent turning a protocol into a full electronic study. And, as always with Rave, accessing Architect simply requires access to an Internet browser and a secure login.

Study teams can easily configure CRFs, sophisticated workflows, data blinding, source document verification and review requirements, dictionary coding and even complex edit checks via a point-and-click interface and design specifications are created and updated automatically.

Leverage existing study assets for streamlined study builds

Medidata Rave Architect's Global Library provides a powerful means of streamlining the process of building multiple studies, extending the benefits of electronic clinical trials by creating reusable assets. Along with reusability, the Global Library offers built-in security through sponsor-defined permissible viewing and borrowing privileges. Study designers can select entire previously-designed studies or their individual forms or components, including fields, pick lists and edits checks, as cataloged in a sponsor-defined volume structure based on therapeutic area, trial phase or other grouping.

Because of the power and security of Global Library, it can also be used to develop and control a validated set of standards for a company or institution. Reused forms or components from the library maintain a flag indicating their origin, with any further alteration marked as a change which is immediately visible.

Architect Loader, a tool that can simplify study validation and documentation, allows a study to be moved, edited and archived in an offline spreadsheet format. It can move a study across environments: from a development to training or production environment at a sponsor; from one production system to another at a sponsor; or from a sponsor to a contract research organization for study design sharing.