Dec 22, 2022
Introduction The submission of a New Drug Application (NDA) to regulatory authorities and its subsequent...
Nov 08, 2022
By Eyal Wultz, President & Co-Founder, and Bremer Louw, Vice President, Biometrics Operations & Business...
Jan 17, 2022
Ensuring Clinical Trial Data Integrity: Five Things to Remember When Selecting a CRO Partner ...
May 19, 2019
In light of regulatory requirements, CDISC SDTM is now the leading standard for representing clinical...
Oct 24, 2018
The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical...
Oct 24, 2018
Clinical study data is defined by the FDA as information about a person in a...
Oct 24, 2018
The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that...
Oct 24, 2018
The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for...
Oct 24, 2018
SEND (Standard for Exchange of Nonclinical Data) is a means of implementing CDISC Standard Data Tabulation Model (SDTM)...