EMS News – Trial Master File Reference Model

eTMF Exchange Mechanism Standard: Publication of New Release

Release 19.3.2 of the eTMF Exchange Mechanism Standard (eTMF-EMS) has been published, effective October 25. This is a minor release related to changes and updates to the specification for the eTMF-EMS.

You may access the Release Notes, as well as the specification for the eTMF-EMS, version 1.0.1 on the Resources web page.

FREE Webinar: Embracing the TMF Exchange Mechanism Standard

Final reminder that our next free Exchange Mechanism Standard (EMS) webinar is on Thursday December 13 at 7am PT, 10am ET, 3pm UTC, 4pm CET, kindly hosted by Wingspan Technology (an IQVIA company). Learn about the key success factors facing life sciences professionals in embracing the emerging TMF Exchange Mechanism Standard.
Register directly by clicking HERE.

Webinar Reminder: October 11, 2018

Register today for the FREE webinar: TMF Reference Model: eTMF Exchange Mechanism Standard (eTMF-EMS) – A Technical Perspective
DATE: October 11 @ 10:00am EDT
In our upcoming webinar, we will cover technical perspectives of the Exchange Mechanism Standard. We will start by going over a recap of the standard and how it can help your current systems and processes.
This webinar will cover:

What is the TMF EMS?
How does the standard work and how it could be used?
How can sponsors, CROs and vendors implement the standard in their eTMF?
Insights into the practicalities of implementing the standard technically

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

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.