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 ...

One key goal of this initiative is to facilitate the participation of investigators and investigative site personnel in clinical trials by allowing them to enter data in a common format across trials.

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, ...

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 ...

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 ...

AUSTIN, Texas--(BUSINESS WIRE)--The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has released the requirements of clinical trial data submission in the ...

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 ...

areas that are important to public health. “The CFAST initiative continues to drive progress in developing therapeutic area standards for some of the world’s most pressing health concerns,” said ...

The Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute (C-Path), and TransCelerate BioPharma, Inc. (TransCelerate), announce the open availability of a CDISC Therapeutic ...

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 ...

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance ...