Commitment to CDISC and
Open industry standards are key to true interoperability across clinical systems. Medidata has long been committed to incorporating the use of standards such as those provided by the Clinical Data Interchange Standards Consortium (CDISC) through application capabilities, implementation and support services.
Medidata is a CDISC Corporate Sponsor and Registered Solutions Provider, and our professionals have been formally recognized by CDISC for their individual contributions. Through ongoing participation in CDISC and other standards bodies, Medidata ensures that its existing and future product capabilities and services will continue to address the interoperability requirements that industry standard support enables.
CDISC Operational Data Model (ODM)
Medidata is CDISC ODM certified and a recipient of the Outstanding Contribution Award for activity in the ODM group. Our products communicate with each other and other clinical systems using ODM-compliant XML files and messages, and Medidata Rave EDC/CDM leads the industry as the first product certified on all eight of CDISC’s ODM use cases:
- ODM Metadata Snapshot—Import and Export
- ODM Data Snapshot—Import and Export
- ODM Metadata Transactional—Import and Export
- ODM Data Transactional—Import and Export
Additionally, Medidata Designer®, an innovative, eClinical design solution designed to allow sponsors focus resources on the science of study design, is the only ODM-certified application capable of generating structured protocol information.
Our customers can rest assured that their operational data and metadata, including audit trail, will be accessible using standards-based protocols, and that Medidata products will be interoperable with all other components in their clinical IT ecosystem that adhere to these standards. This interoperability can be directly translated to saved time and money and reduced risk in deploying and using clinical trial systems.
CDISC Study Data Tabulation Model (SDTM)
Beyond its importance as the FDA’s recommended format for electronic submission of CRF data, SDTM has emerged as an important standard for the warehousing of clinical data. To address this critical customer need, Medidata now offers Medidata Standards Accelerator, which provides end-to-end support for SDTM-compliant outputs in an optimized and repeatable fashion, enabling sponsors to satisfy FDA submission guidelines in less time and at a lower cost. Leveraging Medidata services expertise in standards support, the solution includes multiple pre-built components, including CDASH forms for 17 standard SDTM domains, Medidata Rave dictionaries using CDISC controlled terminology, and Rave edit checks and custom functions that help to enforce the SDTM standard.
CDISC Clinical Data Acquisition Standards Harmonization (CDASH) Standard
Medidata offers preconfigured, QC-tested, CDASH-compliant eCRF metadata mapped to STDM extracts as the basis for internal standards or as a starting point for study builds. They enable sponsors to jumpstart EDC set-up, tailor studies to their specific needs quickly and efficiently, and reduce the risk and complexity involved in adopting a standards-based approach to study-builds.
ICH Clinical Safety Data Management E2B Standard
By integrating electronic clinical data capture, SAE collection and communication processes, Rave Safety Gateway streamlines the workflow between sites, safety and data management teams. All safety-related data directly captured in Rave can be extracted into E2B files and transmitted to any E2B-compatible safety system. Reconciliation efforts to resolve discrepancies between safety and clinical databases are greatly minimized.
CDISC Protocol Representation Model (PRM)
Medidata is the co-lead of CDISC Protocol Representation Group (PRG). Additionally, Medidata Designer is the only product certified on PRM, which is based on the BRIDG Release 3.0 Protocol Representation sub-domain.