Regulatory requirements for annotated CRFs made easy
aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for…
Certara2024年8月26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…
Certara2024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…
Certara2024年8月7日
A guide to CDISC standards used in clinical research
An overview of CDISC standards in the clinical research process. Learn about content standards, data…
Certara2024年7月29日
3 Things You Should Know About ADaM Standards
Learn the key aspects of ADaM standards, including the difference between SDTM and ADaM and…
Certara2024年7月4日
Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model?
2024年6月27日 Advances in technology and changes to the regulatory environment have resulted in…
Certara2024年6月27日
A Best Practice Guide to CRF Design
Design quality, effective and reusable case report forms with our CRF Design Guide. Download the…
Certara2024年6月7日
Demystifying CDISC, SDTM, and ADaM
Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…
Certara2024年5月22日
Leveling Up SDTM Validation with the Magic of Data Managers
In this abstract, Julie Ann Hood and Jennifer Manzi look at how you can improve…
Certara2024年5月19日
How one university overcame practical and cultural challenges to implement CDISC compliance
A US-based university with a nationally recognized academic health center implemented Clinical Data Interchange Standards…
Certara2024年5月8日
