Navigation Links
CareLex Builds Support for Developing Interoperability Standard for Clinical Trial Data Exchange
Date:9/4/2013

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.

About CareLex

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/.

Read the full story at http://www.prweb.com/releases/2013/9/prweb11088154.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. UK nanodevice builds electricity from tiny pieces
2. Rice builds nanotube photodetector
3. Core Facility Management Software Company Builds API to Extend Complex Workflows in Research
4. Synteract and MediciNova Partner in "Fight For Air Walk" to Support the American Lung Association in California
5. inVentiv Health Selected to Provide Sales Operations Support for Santarus
6. Elsevier Supports International Crisis Aid Through Pillars of Hope Campaign
7. Elsevier Foundation Awards 2011 Grants to Advance Women in Science and Support Libraries in Developing Countries
8. ERT Launches New Website to Support Significant Commercial Growth
9. NSF CAREER grants support ocean energy, microforming, computer planning
10. Discovery in Nature elucidates immune cells in skin and supports novel vaccine approach
11. Interim Clinical Trial Results Confirm Safety of Renadyl™, a Probiotic Dietary Supplement for the Support of Healthy Kidney Function
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/16/2017)... and OXFORD, England , Aug. ... -based consortium for biotech executive search and leadership development, and ... Healthcare sectors, have created an exclusive alliance that enables clients ... "For our clients here in ... provides unparalleled access to a diverse population of leadership talent ...
(Date:8/15/2017)... Diego, CA (PRWEB) , ... August 15, 2017 ... ... company pioneering graphene biosensors that accelerate pharmaceutical and biotherapeutics development, announces the launch ... the number of steps needed to gain kinetic binding data for a wide ...
(Date:8/15/2017)... ... August 15, 2017 , ... Kenall, a leader in ... to stay tightly sealed and perform efficiently for years. The downlights are ideal ... just aren't enough, such as: hospitals; behavioral health facilities; cleanrooms; containment areas; food ...
(Date:8/15/2017)... ... August 15, 2017 , ... ... Now mobile responsive, the new website makes it easy to navigate through the ... Users can now find detailed product information, educational industry content and visit the ...
Breaking Biology Technology:
(Date:6/30/2017)... ARLINGTON, Va. , June 30, 2017 /PRNewswire-USNewswire/ ... a leading developer and supplier of face and ... the ATA Featured Product provider program. ... created an innovative way to monitor a driver,s ... benefit greatly from being able to detect fatigue ...
(Date:5/16/2017)... TEANECK, N.J. , May 16, 2017  Veratad ... leading provider of online age and identity verification solutions, ... the K(NO)W Identity Conference 2017, May 15 thru May ... Ronald Regan Building and International Trade Center. ... across the globe and in today,s quickly evolving digital ...
(Date:4/19/2017)... April 19, 2017 The global ... landscape is marked by the presence of several large ... held by five major players - 3M Cogent, NEC ... accounted for nearly 61% of the global military biometric ... in the global military biometrics market boast global presence, ...
Breaking Biology News(10 mins):