The SDTM Mapping Process Simplified
SDTM mapping can be one of the most challenging programming problems in a clinical trial…
CertaraSeptember 16, 2024
What Are SDTM Supplemental Qualifiers?
A detailed look at data that exists out with SDTM variables, known as SDTM supplemental…
CertaraSeptember 16, 2024
Define.xml Submission Checklist
Learn how to create a compliant Define.xml submission package with our Define.xml submission checklist, and…
CertaraAugust 29, 2024
Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator
The article "Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system…
CertaraAugust 26, 2024
Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)
The article “Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL)…
CertaraAugust 26, 2024
Streamline your clinical trials with automated metadata management
When it comes to efficient clinical study build, content is king. Most importantly: metadata content.…
CertaraAugust 26, 2024
Regulatory requirements for annotated CRFs made easy
aCRFs are a key submission deliverable for any clinical trial. In this blog, we break…
CertaraAugust 26, 2024
Automation in clinical trials: Why it’s essential for success
Many companies in the life sciences industry are slow to adopt new technologies. This is…
CertaraAugust 19, 2024
All you need to know about NCI, CDISC and SDTM controlled terminology
The use of controlled terminology (CT) is vital to successful clinical study build. In clinical…
CertaraAugust 13, 2024
