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 ...
FierceBiotech

Clinovo Launches TechTrainings on CDISC Standards

Clinovo Launches a New Hands-on "CDISC Standards: Theory and Application" Class for Industry Professionals to Master Clinical Data Standards. Clinovo's new "CDISC Standards: Theory and Application" ...
Business Wire

China’s Center for Drug Evaluation of the National Medical Products Administration Commits to CDISC Standards

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 ...
RAPS

Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data ...
News Medical

CDISC and C-Path develop new standard to streamline data for animal rule studies

The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Foundational Standard that describes how to represent data for the natural history and efficacy studies ...