Regulatory requirements for annotated CRFs made easy Blog 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 Blog 有关 NCI、CDISC 和 SDTM 受控术语的所有信息 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 Guide 临床 MDR 快速实施指南 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 Blog 临床研究中使用的 CDISC 标准指南 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 Blog 关于 ADaM 标准您应该知道的 3 件事 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? 博客 未来的临床研究设计:CDISC、FHIR、OMOP 还是混合模式? 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 Guide CRF 设计最佳实践指南 借助 CRF 设计指南打造优质、高效且可复用的病例报告表。Download the…Simona Colucci2024 年 6 月 7 日
Demystifying CDISC, SDTM, and ADaM Blog 阐明 CDISC、SDTM 和 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 Blog 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 Case Study 一所大学是如何克服实际操作和文化挑战来实施 CDISC 合规性的 A US-based university with a nationally recognized academic health center implemented Clinical Data Interchange Standards…Danielle Pillsbury2024 年 5 月 8 日