CDISC Announces Launch of CDISC eSHARE

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CDISC standards now electronically accessible by computer applications

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The availability of published CDISC standards in a machine-readable format is an important step along the path to achieving the future vision of end-to-end data flow and interoperability.

The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the official launch of CDISC eSHARE. For the first time, CDISC metadata standards in multiple formats are now electronically accessible by computer applications through an integrated system. eSHARE enables standards-based automation, which is key to increasing ROI from standards implementation.

CDISC SHARE (Shared Health And Research Electronic Library), comprised of both eSHARE (SHARE Exports) and iSHARE (SHARE Interactive), is a global electronic repository for developing, integrating and accessing CDISC standards metadata in electronic format. SHARE should dramatically improve the quality, reusability and integration across CDISC standards and controlled terminologies, and improve interoperability with healthcare. It is anticipated that SHARE will assist in aligning research concepts with external healthcare concepts, and will help CDISC realize the promise of defining data standards once so that data can be reused many times for multiple research purposes.

The launch of eSHARE is a major milestone in standards development at CDISC, which would not have been possible without the support and participation of a large number of volunteers and benefactors, especially TransCelerate BioPharma, Inc. “TransCelerate is happy to support the SHARE effort by CDISC and its connection to the Therapeutic Area Clinical Data Standards initiative on which we partner with CFAST,” said David Jordan, PhD, Clinical Data Standards Leader for TransCelerate. “The availability of published CDISC standards in a machine-readable format is an important step along the path to achieving the future vision of end-to-end data flow and interoperability.”

As a complement to CDISC eSHARE, CDISC iSHARE provides the standards development and governance functions of the SHARE metadata repository. “iSHARE is the metadata management and repository tool for standards developer and curators. You can think of iSHARE as the factory and the warehouse where the standards are developed and maintained, then we export that content into eSHARE, which is the outlet where consumers can easily download that content for use,” stated Sam Hume, CDISC VP of SHARE Technology & Services.

eSHARE, which can be accessed from the new CDISC website, is a webpage that provides a simple-to-use means of accessing this machine-readable metadata, and its interface requires no training to use. Access to CDISC eSHARE is currently free for CDISC Platinum Members and can be found through the Members Only Area of the CDISC website under "eSHARE Downloads."

For more information about CDISC SHARE, including SHARE FAQs, please visit the SHARE webpage on the CDISC website. Interested in gaining access to CDISC SHARE? Please consider CDISC Membership! For inquiries regarding membership in CDISC, please contact Sheila Leaman, Director of Global CDISC Relations (sleaman@cdisc.org).

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 350 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

ABOUT TransCelerate BioPharma Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization's mission is to collaborate across the global R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of medicines. TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research and Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.

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