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eTMF.org - Defining how BioPharma and Health Science regulatory documents can be shared and exchanged on the internet and in clinical trials

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eTMF.org - Defining how BioPharma and Health Science regulatory documents can be shared and exchanged on the internet and in clinical trials

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FAQs About eTMF.org

http://www.etmf.org/index.php/about/faqs-about-etmf

FAQs About eTMF.org. Created on 07 May 2013. Last Updated on 07 May 2013. Written by Zack Schmidt. Want to know more? Here are some questions/answers about eTMF.org:. Q: Why was eTMF.org started? Answer: eTMF.org was started to solve a common problem that many BioPharma organizations face - how to organize and classify electronic documents, content and related records using a methodical, standards-based approach that enables seamless content model sharing and record exchange with others.

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Welcome to eTMF.org

http://www.etmf.org/index.php/34-about-etmf/organization/45-welcome-to-etmf?tmpl=component&amp;print=1&amp;page=

Welcome to eTMF.org. Last Updated on 17 July 2014. What is an eTMF? Electronic Trial Master File systems, or eTMFs, are specialized enterprise content management systems that are used to manage clinical trial content. To enable productivity in eTMF content management area through interoperability, eTMF.org worked with CareLex.org. To publish a specification for eTMF content management. The resulting CareLex eTMF Reference model. Is published at CareLex. For use in eTMF content management applications&#46...

3

Experts

http://www.etmf.org/index.php/experts

Created on 20 February 2012. Last Updated on 07 May 2013. ETMForg Expert Panel Members. The eTMF.org Expert Panel members have deep domain area expertise in one or more of the following domain areas:. BioPharma Research and Development. Clinical Trial Regulatory Document Management. Document Management Systems for Clinical Trials. Content Management Systems for Clinical Trials. Enterprise Application Design and Development. Database Design and Development. Employment: Wyeth, Peking University.

4

Publications

http://www.etmf.org/index.php/publications

CareLex Specification V1.0 for eTMF. Created on 08 May 2013. Last Updated on 08 May 2013. CareLex Specification V1.0 has been released. View it at http:/ www.CareLex.org/publications. What is an eTMF system and why do you need one? Created on 20 February 2012. Last Updated on 17 July 2014. Written by Zack Schmidt, MBA Exec Dir, CareLex http:/ www.CareLex.org. July 2014 eTMF.org update:. Keys to Success in Moving from Paper-based TMF Archives to Electronic TMF Archives. While the paper-based TMF reference...

5

Resources

http://www.etmf.org/index.php/resources

What is an eTMF system and why do you need one? Created on 20 February 2012. Last Updated on 17 July 2014. Written by Zack Schmidt, MBA Exec Dir, CareLex http:/ www.CareLex.org. July 2014 eTMF.org update:. The global standards group OASIS open has published the OASIS eTMF Standard draft specification. Visit http:/ oasis-open.org/committees/etmf. Keys to Success in Moving from Paper-based TMF Archives to Electronic TMF Archives. That would make it suitable for use as a schema for an eTMF:. An effective eT...

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eTMF Consulting | | SterlingBio

http://www.sterlingbio.com/etmf-consulting

Press Releases and Articles. Press Releases and Articles. Leading the Industry in standards-based eTMF development. SterlingBio has been involved in eTMF development since 2008, and is a recognized industry leader in the eTMF area, having designed, developed and deployed multiple eTMF solutions successfully on studies that have received FDA approvals. Get involved in industry eTMF developments at The Haig, a non-profit group for BioPharma and Healthcare industry content model and taxonomy development.

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Welcome to eTMF.org. Last Updated on 17 July 2014. What is an eTMF? Electronic Trial Master File systems, or eTMFs, are specialized enterprise content management systems that are used to manage clinical trial content. To enable productivity in eTMF content management area through interoperability, eTMF.org worked with CareLex.org. To publish a specification for eTMF content management. The resulting CareLex eTMF Reference model. Is published at CareLex. For use in eTMF content management applications&#46...

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