Montrium, industry leading provider of cloud-based collaborative and compliant document and quality management system, announced recently this month it will be fully compliant with the TMF Reference Model Version 1.0 of the eTMF-EMS (eTMF Exchange Mechanism Standard).
This month, TMF Reference Model is about to release version 1.0 of the eTMF-EMS (eTMF Exchange Mechanism Standard). This standard is a major milestone as it will help resolve one of the top issues that the industry faces when trying to transfer eTMF content electronically either during the study or at the end of the study. This standard will significantly facilitate eTMF artefact interchange between organizations and systems. The ability to bridge the systems gap and facilitate interchange of eTMF content, metadata and audit trail information through the use of the eTMF-EMS will be a big win in the clinical trial industry.
This new standard was developed over a 3-year period with input from sponsors, CROs and vendors. Montrium will be one of the first to implement and become fully compliant. Montrium will be developing functionality within their eTMF Connect product to support the new standard and allow both the export and import of EMS transfers.
Paul Fenton, co-chair of the eTMF – EMS group and President and CEO of Montrium said “The eTMF-EMS group of volunteers worked very hard to come up with a standard that would be flexible and easy to implement within the vendor community. The first version of the standard will already allow us to start to integrate across systems much more seamlessly and the EMS group will continue to work to improve the standard and add more capabilities as the eTMF environment evolves and changes.”
Paul Fenton will be presenting the new standard alongside co-chair Elvin Thalund of GoBalto and Ken Keefer at the DIA Annual Meeting on Tuesday, June 26 at 17:30 at the Westin Boston Waterfront Hotel. A meeting space is being provided by DIA and the vendor community is welcomed and encouraged to participate. You do not need to register in advance, look out for the room number at the event.
About The TMF Reference Model eTMF-EMS
The TMF reference model eTMF-EMS subgroup was founded in 2015 and has been developing a standard which is aligned with the main TMF Reference Model to facilitate interchange of TMF content between organizations and systems.
Montrium is a knowledge based company that focuses on leveraging its deep understanding of GxP processes and technologies to provide cost-effective solutions to life science organizations. Montrium’s industry leading cloud-based solution, Montrium Connect, offers a collaborative and compliant document and quality management environment. Montrium is based on a subscription model that allows access the applications for an easy-to-manage per user monthly fee. For more information, visit www.montrium.com.