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.
New York, NY – 28 Aug 2018 – The Leona M. and Harry B. Helmsley Charitable Trust announced today $5.4 million in funding to the Clinical Data Interchange Standards Consortium (CDISC), supporting its work to standardize clinical data to ease data sharing among research scientists and to improve medical research around the globe.
Austin, TX – 30 MAY 2018 – CDISC is pleased to announce long-time standards advocate, skilled instructor and current European Liaison, Peter Van Reusel, as the organization’s Chief Standards Officer.
With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC kicked off our program to develop Type 1 Diabetes-related Data Standards. The program's goal is to facilitate data sharing by standardizing the data to lead to innovation in research.
CDISC invites you to attend a public broadcast of SEND topics during the CDISC SEND Team's spring face-to-face meeting at the FDA CDER facility. The broadcast is an opportunity for stakeholders to stay informed on what's going on with the development of SEND as well as ask any questions you may have to FDA reviewers. FDA reviewers will also have the opportunity to ask questions to Sponsors.
PUBLIC BROADCAST, April 25, 2018 1:00 - 4:30PM EDT
