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
Austin, TX – 28 MAR 2018 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce it has been awarded a grant in the amount of $1,000,000 by The Leona M. and Harry B. Helmsley Charitable Trust to develop Type 1 Diabetes (T1D)-related data standards.
Austin, TX – 18 January 2018– The Clinical Data Interchange Standards Consortium (CDISC) today announced Chris Decker and Pam Howard have joined its Board of Directors to serve three-year terms, which began 1 January 2018.
TUCSON, Ariz., and AUSTIN, Texas – October 18, 2017 – Critical Path Institute (C-Path) and The Clinical Data Interchange Standards Consortium (CDISC) announce the open availability of a Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD v1.0), which describes the most common clinical concepts relevant to Duchenne studies using the CDISC standard format. This format allows datasets from different sources to be compared or combined for data collection, sharing, and analyses.
AUSTIN, Texas – 20 SEP 2017 – The Clinical Data Interchange Standards Consortium (CDISC) and Cohen Veterans Bioscience announce the availability of a Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) for public review.
TUCSON, AZ, NEW YORK, NY, and AUSTIN, TX – September 11, 2017 – Critical Path Institute (C-Path), CHDI Foundation, Inc. (CHDI), and The Clinical Data Interchange Standards Consortium (CDISC) announce the availability of a draft Huntington's disease (HD) Therapeutic Area User Guide (TAUG-HD v1.0) for public review. The TAUG-HD v1.0 describes how HD clinical data should be recorded in a standardized database to establish common best practices across the healthcare industry for the recording, reporting, and sharing of clinically relevant disease-specific metadata, research data, and patient information. Use of the standard will allow the HD research community to compare and contrast data from different studies more easily and with more scientific rigor, and will make it easier for researchers to understand natural history, biomarker, and trial data in the future. It will also facilitate regulatory submissions for novel therapeutics.
Austin, TX – 07 SEP 2017 – The Clinical Data Interchange Standards Consortium (CDISC) and the Pharmaceutical Users Software Exchange (PhUSE) announced today an evolution of their partnership to strengthen their work around the development and implementation of beginning-to-end standards.
