CDISC and TransCelerate BioPharma Inc. Announce Plans to Implement CDISC SHARE

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.