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
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
3 Things You Should Know About ADaM Standards
Learn the key aspects of ADaM standards, including the difference between SDTM and ADaM and…
Simona Colucci2024 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…
Simona Colucci2024 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…
Simona Colucci2024 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…
Nathan Teuscher2024 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…
Danielle Pillsbury2024 年 5 月 8 日
