The SDTM Mapping Process Simplified
SDTM mapping can be one of the most challenging programming problems in a clinical trial…
Simona Colucci2024 年 9 月 16 日
What Are SDTM Supplemental Qualifiers?
We touched on the SDTM supplemental qualifier in the SDTM mapping process simplified. In this…
Simona Colucci2024 年 9 月 16 日
Define.xml Submission Checklist
Learn how to create a compliant Define.xml submission package with our Define.xml submission checklist, and…
Simona Colucci2024 年 8 月 29 日
Streamline your clinical trials with automated metadata management
When it comes to efficient clinical study build, content is king. Most importantly: metadata content.…
Simona Colucci2024 年 8 月 26 日
Regulatory requirements for annotated CRFs made easy
aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for…
Simona Colucci2024 年 8 月 26 日
Automation in clinical trials: Why it’s essential for success
生命科学行业的许多公司在采用新技术方面进展缓慢。This is…
Simona Colucci2024 年 8 月 19 日
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…
Simona Colucci2024 年 8 月 13 日
A quick guide to implementing a Clinical MDR
Read our free guide to learn the three-step best practice process to implementing a Clinical…
Simona Colucci2024 年 8 月 7 日
A guide to CDISC standards used in clinical research
The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to helping improve medical research through…
Simona Colucci2024 年 7 月 29 日
Pinnacle 21 Enterprise Analytics: Case Studies from the Field
In this blog, we look at some examples of how Pinnacle 21 Enterprise Analytics (P21E)…
Certara2024 年 7 月 15 日
