Bridging Regulatory Quality and Operational Efficiency with Open Standards

Save your seat for the upcoming webinar!
Accelerating clinical trials with open standards
Central to the elimination of bottlenecks and unnecessary rework in the clinical trial continuum is automation and integration between eClinical applications based on open standards.
Existing systems (CTMS, eTMF, etc.) only support clinical trial functions in silos. The challenges in integration of eClinical systems stems from the lack of standards, it’s simply not enough to have APIs available.
Standards provide stakeholders with a basis for mutual understanding and are critical tools to facilitate communications. Open standards help fuel compatibility, interoperability, simplify trial executions and speed time-to-market.
The new eTMF Exchange Mechanism provides the cornerstone in collaboration between all study startup and executive stakeholders, including sponsors, CROs, investigative sites and regulatory and ethical committees.
Date/Time:  August 28, 2018 @ 3:00 pm BST, 10 am ET, 7 am PT
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EMS Charter Published

Following review by the TMF Reference Model Steering Committee, the Charter of the Exchange Mechanism Standard (EMS) subgroup has been finalized and published. The Charter can be downloaded here.

Industry Feedback on Draft Standard Now Under Review

Following a consultation period in which industry representatives were provided with an opportunity to review the draft TMF Exchange Mechanism Standard, their feedback is now being reviewed by the Exchange Mechanism business and vendor teams. Feedback has been provided by a wide range of stakeholders, including trial sponsors, CROs, consultants, eTMF vendors and other service and system providers.

Completion of the feedback review is expected around March/April, following which the revised standard will go through a road-test. Any willing vendor or business users who would like to participate in the road-test should contact the exchange team.