There is an urgent need for a globally available, open eTMF standard that will accelerate automated information exchange and interoperability" --Zack Schmidt, CareLex Executive Director
Silicon Valley, California (PRWEB) September 04, 2013
CareLex, a non-profit organization for BioInformatics research, today announced plans to develop an Electronic Trial Master File (eTMF) standard that will modernize traditional paper-based clinical trial data by enabling the use of interoperable information systems. The work, which will build on the recently published eTMF Reference Model for BioPharma, is intended to be advanced as an activity of the OASIS international open standards consortium.
The new eTMF standards initiative will engage global pharmaceutical regulatory agencies, clinical trial sponsors, research organizations, consultants, industry groups and others in the BioPharma industry. These organizations will collaborate to evaluate current technologies, identify content classification models, and define an open, internationally recognized standard that will assure information interoperability among clinical trial stakeholders.
"We are excited to see increased interest and adoption of eTMF systems in clinical trials; however, without an open, standards-based eTMF content model, document and record sharing will continue to be inefficient and subject to human data entry errors," said Zachariah Schmidt, Executive Director and Founder of CareLex. "There is an urgent need for a globally available, open eTMF standard that will accelerate automated information exchange and interoperability, and that will facilitate regulatory agency compliance. The eTMF standard is essential for ensuring delivery of safe therapies to patients."
Schmidt is gathering support from key healthcare organizations, government agencies, and industry experts and expects to convene an eTMF Technical Committee at OASIS in the coming weeks.
"At OASIS, we are committed to coordinating our efforts with BioPharma stakeholders and regulatory agencies worldwide to advance the development of specifications that leverage interoperable standards for the clinical trials area," said Laurent Liscia, executive director and CEO of OASIS. "We look forward to advancing the eTMF work."
Individuals with demonstrated expertise in domain areas related to clinical trial content classification, regulatory compliance, content management or software information modeling are invited to take a leadership role in the eTMF standardization initiative. Participation will be open to all interested parties. Details are available by contacting Zack Schmidt via the CareLex website at http://www.CareLex.org or email at admin(at)CareLex(dot)org, OASIS, or email at join(at)oasis-open(dot)org. Join the new LinkedIn eTMF Standards discussion group at http://www.linkedin.com/groups/eTMF-Standards-5161997/about.
CareLex™ is a non-profit public benefit organization for BioInformatics research and development. Organized in 2012 by a core group of clinical trial domain and bioinformatics experts, CareLex provides open source technology for BioPharma content classification and management. CareLex is open to anyone worldwide. For more information, visit http://www.CareLex.org/.