Austin, TX – 20 June 2013 – The Clinical Data Interchange Standards Consortium (CDISC) announced plans today to implement CDISC SHARE. After a comprehensive proposal and evaluation process, SOA Software’s Semantic Manager product was chosen as the SHARE technology platform by a selection committee consisting of CDISC leaders and volunteers, with substantial support from TransCelerate BioPharma Inc. (TransCelerate). “SHARE has been a long-standing strategic priority of CDISC, and is fundamental to our ability to develop and enhance CDISC standards for clinical research and especially for therapeutic areas,” said Wayne Kubick, CDISC CTO. “We at CDISC owe a great deal to TransCelerate, the CDISC Board of Directors and the many individuals who helped make this happen, and we would like to thank all the technology providers who participated in the proposal process.”
SHARE, or Shared Health And Research Electronic Library, a cornerstone of the CDISC technical roadmap, will be a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format. SHARE is expected to dramatically improve integration among CDISC foundational standards and controlled terminologies, and support greater interoperability with healthcare.
Because SHARE is so essential for developing therapeutic area data standards, it has received substantial support from TransCelerate BioPharma, which has provided significant financial and personnel resources. “TransCelerate is happy to support the SHARE effort by CDISC and its connection to the Clinical Data Standards initiative on which we partner through CFAST,” said Dalvir Gill, PhD, Chief Executive Officer of TransCelerate. “SHARE is aligned with our own goal of collaborating to improve data flow, quality, speed, efficiency and capabilities in clinical trials – ultimately bringing new therapeutics to patients.”
With the continued help and support of the CDISC member community, partners such as TransCelerate, NCI’s Enterprise Vocabulary Services and now SOA Software, CDISC can now move forward even more rapidly to facilitate the development and expanded use of consistent, high quality, comprehensive clinical data standards to improve medical research and related areas of healthcare.
Development of content for SHARE has been in progress for quite some time. SHARE technology implementation has now commenced with a goal of providing an initial production release for use by the CDISC community by early 2014. SHARE electronic metadata will be made available in formats including Excel, ODM, Define-xml and RDF to the world of medical research once the system implementation is complete. CDISC will be providing additional details on its website in coming months and through CDISC webinars and various meetings, including the DIA annual meeting this month.
CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 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. was formed in 2012 and is a non-profit organization focused on advancing innovation in research and development (R&D), identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. TransCelerate evolved from discussions at various forums for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. Founding members include Abbott/AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi, and all have representation on the Board of Directors. Additional members include Astellas Pharma Inc., Biogen Idec, Braeburn Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.) and Onyx Pharmaceuticals.
Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.