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 ...
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 ...
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 ...
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 ...
Importantly, Pharsight has worked with FDA to streamline the process of loading data from New Drug Applications (NDAs) into PKS by integrating the FDA's internal data management tools with Pharsight's ...
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" ...
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 ...
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