Newsroom

CDISC invites you to an FDA-hosted public broadcast during the SEND Team’s spring virtual meetings. The broadcast is an opportunity for stakeholders to stay informed on what’s going on with the development of SEND and it’s use in regulatory submissions.

14 April, 2021 9:00 am – 12:30pm EDT

Agenda

9:00am – 9:45am CDER OCS Presentation - Jesse Anderson

9:45am – 10:00am Break

10:00am – 10:45am OBI/eData Team Update – Ethan Chen

Austin, TX and Copenhagen, DK – 31 Mar 2021 – CDISC announced a collaboration with A3 Informatics to create industry-standard Biomedical Concepts with the goal of supporting their awareness and encouraging their adoption in clinical research. CDISC Biomedical Concepts form a reference information model that standardizes clinical research concepts and their representation in underlying data models.

Austin, TX – 17 December 2020 – CDISC announced that industry veteran David A. Evans will join the organization as its new President and Chief Executive Officer effective January 1, 2021. Dave brings over 35 years’ experience serving in various executive-level positions in software development, clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions and as an expert in the areas of information standards, regulatory compliance and quality governance. The architect and developer of the first electronic drug submission to the US FDA in 1985, Dave has been responsible for more than 100 electronic regulatory submissions and complex

AUSTIN, TX – 23 Sep 2020 – CDISC is pleased to announce Dr. Maria Im Hee Shin of Daegu Catholic University Medical Center in South Korea has been named Chair of the Korea CDISC Coordinating Committee (K3C). CDISC Coordinating Committees (3Cs) support global CDISC initiatives within specific regions of the world and provide regional feedback to the central CDISC organization.

Austin, TX – 10 September 2020 – Today CDISC and Microsoft co-hosted a virtual workshop to shape the future of standards and technology by planning the next generation CDISC Library. The CDISC Library metadata repository serves as the single, trusted, authoritative source of CDISC standards metadata for the clinical research community.

Austin, TX – 15 June 2020 – CDISC has entered into a partnership with the Japan Agency for Medical Research and Development (AMED) to train leading academic researchers in Japan on standardizing data using CDISC standards.

Austin, TX – 05 May 2020 – CDISC has launched a project that will facilitate the use of electronic health record (EHR) data in clinical research to achieve efficiencies that expedite global regulatory reviews, contribute to the evaluation of new treatments for patients and drive next generation discovery.