Keep up to date with the latest developments at CDISC and follow our news feeds!

Austin, Texas, USA and Geneva, Switzerland - The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a clinical protocol template and technical specification to ensure clinical study protocols are prepared in a consistent manner and provided to users in a harmonised data exchange format acceptable to all regulatory authorities of the ICH regions.  This protocol and electronic exchange format will facilitate the streamlining and exchange of protocol information and support fu

Austin, TX, USA and Uppsala, Sweden – 22 January 2024 – A new collaboration between two leading organizations in global medical data has been announced to bring greater efficiency and certainty to regulatory bodies, industry, and the healthcare community, ultimately aiming to improve patient safety worldwide.

Austin, TX – January 16, 2024 – CDISC is proud to announce a research collaboration with the U.S. Food and Drug Administration’s Office of Translational Sciences in the Center for Drug Evaluation and Research and Office of Regulatory Operations in the Center for Biologics Evaluation and Research to incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE).

Austin, TX – January 2, 2024 – CDISC announces industry veteran Chris Decker is joining the organization as its new President and Chief Executive Officer effective January 2, 2024, succeeding Dave Evans who will be transitioning into retirement after decades of outstanding service to CDISC. 

The European Organisation for Research and Treatment of Cancer (EORTC) is pleased to announce a new collaboration with CDISC, a leading provider of data standards in clinical research.

With its Quality of Life measures, EORTC provides the wide research community with questionnaires through which health-related quality of life of cancer patients and survivors can be assessed and their experience put at the forefront. 

Austin, TX and Boston – 10 October 2023 – Clinical Data Interchange Standards Consortium (CDISC) and Digital Medicine Society (DiMe) are proud to announce a groundbreaking partnership aimed at enhancing the standardization of digital health technologies (DHTs) data.

Philadelphia, PA and Austin, TX - 21 June 2023 - Myota, a prominent data protection platform provider, is excited to announce its newest customer, CDISC, a global standards development organization that serves the clinical research industry.
Ann Arbor, MI. and Austin, TX — 6 June 2023 —A structured, harmonized, digitized protocol accessible to the biopharmaceutical industry and to researchers in the care setting will enable transformations to improve clinical research. The project announced by HL7 Vulcan and CDISC will build on work products of ICH M11 to accelerate this vision.

CDISC invites you to an FDA-hosted public broadcast during the SEND Team’s fall virtual meetings. The broadcast is an opportunity for stakeholders to stay informed on what’s going on with the development of SEND and its use in regulatory submissions, as well as hear from our global SEND user community.

18 October 2023 10:00 – 11:30 am EDT