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TMF Reference Model Exchange Mechanism Standard Bridges Disparate Clinical Data Silos

by Sujay Jadhav

goBalto spearheads initiative to bring standardization to the eClinical stack

TMF Reference Model Exchange Mechanism Standard Bridges Disparate Clinical Data Silos

goBalto announced today its fully integrated framework, compliant with the TMF reference model (version 3.0) XML-based exchange mechanism, is also pending compliance with the new Exchange Mechanism Standard, a first for any non-TMF vendor.

The TMF (Trial Master File) Reference Model provides an opportunity for standardization across the clinical trials industry by providing standardized taxonomy and metadata and outlining a reference definition of TMF content using standard nomenclature. As such, the model is a valuable tool for any organization engaged in clinical trials, including technology providers. The new Exchange Mechanism Standard enables vendors to build an exchange component, which standardizes all TMF related content and metadata exchanged, ensuring focus on the business value of the exchange rather than API calls and vendor management.

The vendor community is invited to participate in a review and discussion at the launch of the standard (, held in conjunction with the DIA Annual Meeting. Elvin Thalund, goBalto's Senior Director of Industry Strategy and co-chair of the TMF Reference Model Exchange Group will be presenting, "Bridging Regulatory Quality and Operational Efficiency with the Exchange Standard."

Elvin Thalund
Co-chair of TMF Reference Model Exchange Group
"Previously, eClinical system integration was left to sponsors and CROs to figure out with multiple vendors. What the TMF exchange mechanism offers is a real opportunity for vendors to get together to proactively solve the integration needs of their customers."

Existing systems (CTMS, eTMF, Study/Investigator Portals, etc.) only support clinical trial functions in silos. The ability to bring together the collective institutional memory and the facilitation between systems and team members is critical, representing an unmet need. The challenges in integration of eClinical systems stems from the lack of standards, it's simply not enough to have APIs available.

Eldin Rammell
Member of TMF Reference Model, Exchange Subgroup
"The TMF exchange format is pivotal and sets the stage for integrations across the whole eClinical stack. The TMF exchange (e.g., standard conventions for file naming and long-term TMF storage formats) has far reaching consequences."
Paul Fenton
Co-chair of TMF Reference Model Exchange Group
"Establishing a TMF exchange format is about creating a platform and process open enough so it can be used by all eClinical vendors."

Eliminating inefficiencies and bottlenecks associated with disparate data silos is critical to the goal of reducing cycle times in clinical trials. Each tool – eTMF, CTMS, and Study Startup – plays a distinct role in optimizing the full clinical trials process; each performs separate functions but serves overlapping user groups.

Sujay Jadhav
goBalto's CEO
"True integration is critical to plug and play coexistence in the eClinical stack. What's required is a deep understanding of the right type of integration at the right time for the different integration points. The TMF exchange format will facilitate these integrations by providing a common language amongst all eClinical vendors. We strongly support this initiative."

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