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?
We touched on the SDTM supplemental qualifier in the SDTM mapping process simplified. In this…
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
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 mandatory requirement of the FDA, and therefore a key submission deliverable for…
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
A quick guide to implementing a Clinical MDR
Read our free guide to learn the three-step best practice process to implementing a Clinical…
CertaraAugust 7, 2024
A guide to CDISC standards used in clinical research
An overview of CDISC standards in the clinical research process. Learn about content standards, data…
CertaraJuly 29, 2024
Pinnacle 21 Enterprise Analytics: Case Studies from the Field
In this blog, we look at some examples of how Pinnacle 21 Enterprise Analytics (P21E)…
CertaraJuly 15, 2024
