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CDISC Founder to Lead ISO/TC215 Genomics Sub-Committee

28 Aug 2019

Austin, TX – 28 Aug 2019 – CDISC congratulates Bron Kisler, a founder of CDISC and long-time executive, on being elected Chair of the ISO/TC 215 Genomics Sub-Committee. Kisler was unanimously elected by 30 member countries from across Asia, Australia, Europe and the Americas. This newly launched Sub-Committee (SC) will standardize genomics data globally across ISO-member nations and beyond. The scope of the Genomics SC is “Standardization of computable data, information, and knowledge, including their representation and metadata, for the application of omics, including but not limited to genomics, transcriptomics and proteomics, to support human health and clinical research.”

Pancreatic Cancer Action Network and CDISC Partner to Develop First Therapeutic Area Data Standards for Pancreatic Cancer

27 Aug 2019

MANHATTAN BEACH, CA and AUSTIN, TX – 27 Aug 2019 – The Pancreatic Cancer Action Network (PanCAN), the leading pancreatic cancer patient advocacy organization, and CDISC, the global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, announced today a collaboration to establish the first-ever data standards specifically for pancreatic cancer.  

CDER Plots Pilot Project to Test CDISC Standard

20 Aug 2019 | Zachary Brennan | RAPS Regulatory Focus

CDISC, C-Path Release Therapeutic Area Standard to Drive Research Forward for Clostridium Difficile Associated Diarrhea

2 May 2019

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).

CDISC, C-Path Develop Therapeutic Area Standard to Foster More Efficient and Meaningful Research for HIV

16 Apr 2019

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.

CDISC to Develop Data Standards for Crohn’s Disease With Support from the Helmsley Charitable Trust

2 Apr 2019

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.

The Turning Point for Clinical Research: Global Data Standardization

30 Jan 2019 | Dr. Nicole Harmon, et al | Applied Clinical Trials

New Leaders Join CDISC 2019 Board of Directors

17 Jan 2019

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.

CDISC and Cohen Veterans Bioscience Announce Release of First Data Standard to Improve Research for Post Traumatic Stress Disorder

12 Dec 2018

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.

CDISC Releases Therapeutic Area User Guide to Bring Clarity to Data for Colorectal Cancer Research

20 Nov 2018

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.