Houston Chronicle

(BW) FDA Announces CDISC Will Lead Industry Collaborators to Define Standards for Clinical Data Collection

AUSTIN, Texas--(BUSINESS WIRE)--July 11, 2006--On Wednesday, 21 June 2006, Janet Woodcock, FDA Deputy Commissioner for Operations and Chief Operating Officer, announced during her DIA presentation, ...
Business Wire

CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE)

AUSTIN, Texas--(BUSINESS WIRE)--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 ...
RAPS

FDA sets CDISC implementation timeline

The US Food and Drug Administration (FDA) will begin supporting updated versions of clinical data interchange standards in the areas of reproductive toxicology and study data tabulation, effective 15 ...
Houston Chronicle

(BW) CDISC and Industry Collaborative Group Lead FDA Critical Path Initiative Opportunity for Data Collection Standards

“From the FDA's perspective, the quality and integrity of the data is paramount. Common standards for case report forms can improve both, and are also a crucial enabler for the biomedical research ...
Medical Xpress

C-Path and CDISC announce therapeutic area user guide for Duchenne Muscular Dystrophy

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 ...
FierceBiotech

Standards from the Start - CDISC in 2010

As always, CDISC begins the year with a flurry of activity (do keep an eye on the website for regular updates and news on the standards). In addition to the CDISC standards themselves, the CDISC Board ...
EurekAlert!

New CDISC data standard aids development of therapies for Ebola virus

The Clinical Data Interchange Standards Consortium (CDISC) and the Infectious Diseases Data Observatory (IDDO) announce the availability of a new standard to assist in the collection, aggregation and ...
Business Wire

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

AUSTIN, Texas & TUCSON, Ariz.--(BUSINESS WIRE)--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 ...
News Medical

C-Path, CHDI and CDISC announce availability of Huntington's Disease Therapeutic Area User Guide

The Huntington's Disease Regulatory Science Consortium (HD-RSC), launched in March 2018 by the Critical Path Institute (C-Path) and CHDI Foundation, today, along with the Clinical Data Interchange ...
RAPS

CDER Plots Pilot Project to Test CDISC Standard

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study ...
EurekAlert!

C-Path and CDISC announce therapeutic area user guide for duchenne muscular dystrophy

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 ...