Medidata Solutions, a provider of SaaS clinical development solutions to biopharma, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, has introduced Medidata Standards Accelerator to enable sponsors to satisfy the US Food and Drug Administration (FDA) submission guidelines.
Medidata Standards Accelerator offers support for the Clinical Data Interchange Standards Consortium (CDISC) study data tabulation model (SDTM) – the FDA approved format for electronic submission of case report form data.
The Standards Accelerator includes multiple tools such as Pre-built CDASH forms for 17 standard SDTM domains; Rave dictionaries using CDISC-controlled terminology; and Edit checks for SDTM validation rules to minimize data errors to streamline the preparation of SDTM-compliant data sets.
Medidata Solutions president Glen de Vries said from Operational Data Model (ODM) to SDTM and others, they will continue to incorporate standards across the development process in platform capabilities and service offerings.