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 conv
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