pharmaphorum

Using SDTM, ADaM, and SEND for Regulatory Submissions

It’s a safe bet that most people’s first introduction to CDISC standards is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a ...
Medindia

PointCross Releases eDataValidator for SDTM, ADaM, SEND, and Define.XML Conformance to Prevailing FDA, CDISC, and PMDA Rules

FOSTER CITY, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- PointCross Life Sciences announced today the full complement release of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML ...
PharmiWeb

How CDISC standards fit into the drug development process

The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential ...
FierceBiotech

ClinPlus®Report 4.0, Dramatically Improves Programmer Productivity for Production of CDISC ADaM Data and Safety Tables & Listin

Bound Brook, NJ (April 3, 2009) - DZS Software announced today the latest release of ClinPlus® Report, the company's powerful authoring software for creating high-quality statistical tables and ...