Interest in the OASIS eTMF Standard Grows

The good news continues here at CareLex, as we continue to see widespread interest and adoption of the proposed OASIS eTMF Standard.     After CareLex contributed its published Content Classification model,  specification and eTMF Reference Model database to the OASIS eTMF Standard initiative, a growing group of of industry leaders have expressed interest in joining forces to move a global eTMF standard forward.

We’re delighted to see growing participation by BioPharma industry stakeholders in the new OASIS eTMF Standards initiative.  With a mutual interest in moving toward interoperable clinical trial content data exchange, the following organizations have joined or expressed interest in joining the OASIS eTMF Standard initiative:

  • SafeBiopharma Association
  • SureClinical

These organizations clearly see the time saving and cost advantages of moving clinical trials operations from manual paper-based processes to automated electronic business processes.

Our goal here at CareLex is to develop new open source technologies that will accelerate the safe delivery of new drug therapies to patients.  Technologies that eliminate or reduce the use of manual paper-based processes in clinical trials hold the promise of getting new drugs to patients faster at a lower cost.   We’re excited that we have been able to help move new technologies forward as potential standards that are valuable resources for use by industry, vendors and clinical trial stakeholders.

The online CareLex eTMF content model is available for free download from NCBO BioPortal.  The National Center for Biomedical Ontology is one of the National Centers for Biomedical Computing supported by the NHGRI, the NHLBI, and the NIH.

To view the CareLex content classification model for the eTMF domain, just go to the following link:

For information on how to use the CareLex content classification model to organize electronic documents and content, visit:

Join the new LinkedIn eTMF Standards group discussion today at:

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