AUSTIN, TX and TUCSON, AZ – 02 May 2019 — CDISC and The Critical Path Institute (C-Path) are pleased to announce the release of a global Therapeutic Area Standard, which describes how to use CDISC standards to represent data in research studies pertaining to Clostridium difficile associated diarrhea (CDAD).
AUSTIN, TX and TUCSON, AZ – 16 Apr 2019 – CDISC and the Critical Path Institute (C-Path) are pleased to announce the release of a global Therapeutic Area Standard that specifies how to structure commonly collected data and outcome measurements in clinical trials for HIV. The standard, released in the form of User Guide for data managers, statisticians, programmers and study managers, covers the areas of prevention, vaccines and treatment and is freely available on the CDISC website.
Austin, TX and New York, NY – 02 Apr 2019 – CDISC will develop the first global, non-proprietary clinical data standards for Crohn’s disease with a grant award of $1 million from The Leona M. and Harry B. Helmsley Charitable Trust. CDISC Standards specify how to structure data to expedite approval of new therapeutics and enable data sharing, cross-study comparisons, and meta-analyses. Consistent data structure supports the automated flow and meaningful exchange of data between all stakeholders including clinicians, researchers, pharmaceutical companies and regulatory authorities.
Austin, TX – 17 January 2019 – CDISC today announced three new members have joined its Board of Directors. Dr. Pandu Kulkarni, Dr. Hiroshi Masumoto, and Dr. Zhengqing Li each began serving a three-year term at the beginning of the year.
AUSTIN, Texas – 12 Dec 2018 – CDISC and Cohen Veterans Bioscience are pleased to announce the publication of a new Therapeutic Area (TA) Standard for Post Traumatic Stress Disorder released in the form of a User Guide for data managers, statisticians, programmers and study managers.
Austin, TX – 20 November 2018 – CDISC is pleased to announce the release of a Therapeutic Area (TA) Standard that specifies how to structure data in clinical research studies for Colorectal Cancer. The standard, released in the form of User Guide for data managers, statisticians, programmers and study managers, is freely available on the CDISC website. CDISC Therapeutic Area User Guides (TAUG) provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.
Austin, TX – 12 OCTOBER 2018 – CDISC wrapped up its 15th annual U.S. conference in Bethesda, MD, where attendees were the first to hear about a number of new initiatives as well as participate in active discussions with regulators including representatives of U.S. FDA and Japan PMDA. CDISC Interchanges are global events held annually on three continents with hundreds of attendees gathering to network, share their expertise, best practices, and lessons learned about implementing CDISC standards to bring clarity to clinical research data.