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
Categorizing & Managing Risks in Aggregate Safety Reports
Categorizing Risks From a sponsor’s first authorization to conduct a clinical drug trial in any…
Certara2024 年 6 月 28 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
Generative AI Tools for Regulatory Writing
监管文件撰写是药物开发过程中的重要组成部分。Regulatory writers must understand…
Certara2024 年 6 月 20 日
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
Certara2024 年 6 月 19 日
Using Real World Data in Clinical Trial Submissions
We explore challenges & best practice recommendations to help you implement submission standards when using…
Certara2024 年 6 月 17 日
Clinical trial data validation: When to transition from P21 Community to Enterprise
Technology is designed to help us live and work smarter. That is exactly what P21’s…
Certara2024 年 6 月 7 日
The Future is Now: Virtual Clinical Trials Transforming Drug Development
Welcome to the forefront of drug development innovation! The drug development landscape is rapidly evolving,…
Certara2024 年 6 月 4 日
Phoenix UGM 2024: A Day of Innovation and Collaboration
The Phoenix UGM featured industry expert insights, peer networking, and glimpses into the latest PK/PD…
Certara2024 年 5 月 31 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
