Apr 22, 2025
Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President Data integrity in clinical trials refers...
Apr 14, 2025
Authored by Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President Over the past few...
May 19, 2024
Data standards support the robust organization, analysis, and reporting of clinical trials and many regulatory...
Apr 19, 2024
If you’re contemplating a Functional Service Provision (FSP) model to enhance your biometric team, understanding...
Apr 19, 2024
Choosing to supplement your internal biometrics team via Functional Service Provision (FSP) offers numerous benefits,...
Apr 19, 2024
Pharma and biotech companies often face the challenge of needing additional biometrics support, whether due...
Nov 08, 2022
Background When a patient presents with a fever or what appears to be an acute...
May 19, 2019
In light of regulatory requirements, CDISC SDTM is now the leading standard for representing 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)...
1 of 1