Cranford, NJ – January 21, 2014 – Paragon Solutions, an advisory consulting and systems integration firm, announced today that it has been invited to participate in the OASIS open standards consortium’s Electronic Trial Master File (eTMF) Standard Technical Committee. The committee has been established to define an international standard for the interoperable exchange of clinical trial content (i.e., documents, images, record data) via electronic content management systems (CMS).
As a member of the committee, Paragon Solutions will help influence the development of a machine-readable content classification model that will be comprised of a standards-based vocabulary and content classification ontology. Paragon will also assist the group as they establish the format for exchanging clinical trial master file content through clinical portals and cloud computing in compliance with government agency requirements.
“We are honored to bring Paragon’s years of eTMF experience to the committee in an effort to help the industry progress toward achieving an eTMF standard for the benefit of all clinical trial stakeholders,” said Associate Director for Paragon’s Clinical and Regulatory Optimization practice Fran Ross, an eTMF subject matter expert and frequent industry speaker on eTMF best practices. “Successful development and alignment in this initiative will enable a new level of interoperability and coherence in eTMF management,” said Ross.
The work of the OASIS eTMF Committee will build on the TMF Reference Model established by the DIA Electronic Document Management community, an initiative Ross and other members of Paragon’s Clinical & Regulatory Optimization practice have been instrumental in driving. The Paragon team will leverage the knowledge and expertise gained by providing numerous life sciences organizations with eTMF strategy and implementation services that ensured a holistic, compliant eTMF deployment in their membership role.
About Paragon Solutions
Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability and regulatory compliance.
Paragon works with businesses that are focused in a few key industries — communications, financial services, healthcare, insurance and life sciences. The industry-focused practices work with Paragon’s competency groups to address today’s client concerns in process optimization, information management and information insight.
For more information, please visit the Paragon website at www.consultparagon.com, or call 1.800.462.5582.