Medidata Solutions Further Extends Support for Industry Standards with Medidata Standards Accelerator

Company News Release

Medidata Solutions announced its latest services offering, Medidata Standards AcceleratorTM, which provides end-to-end support for the Clinical Data Interchange Standards Consortium (CDISC) study data tabulation model (SDTM)–the FDA’s recommended format for electronic submission of case report form data. With this offering, Medidata enables sponsors to satisfy FDA submission guidelines in a repeatable fashion, while reducing time and costs.

Medidata’s services team works with sponsors using the Medidata Rave® electronic data capture (EDC) and clinical data management (CDM) platform throughout the study lifecycle to streamline the preparation of SDTM-ready data and the export of SDTM-compliant datasets. In addition to the best practices utilized by Medidata services professionals, Standards Accelerator includes multiple tools aimed at streamlining the preparation of SDTM-compliant data sets:

  • Pre-built CDASH forms for 17 standard SDTM domains;

  • Rave dictionaries using CDISC-controlled terminology;

  • Edit checks for SDTM validation rules to minimize data errors.

A longtime CDISC Corporate Sponsor and Registered Solution Provider, Medidata has had a number of its executives formally recognized by CDISC for their individual contributions to standard definitions and ongoing participation in standard groups. Additionally, Rave was the first to be software product certified on all eight Operational Data Model (ODM) use-cases for full interoperability and sharing of clinical data. Rave also was the first EDC solution to provide clinical data acquisition standards harmonization (CDASH) metadata. Medidata Designer®, a study protocol and design solution, has contributed its model to CDISC’s protocol representation model.