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
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
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates
In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…
Certara2024 年 5 月 10 日
为什么临床数据标准对 EDC 和 Non-EDC 数据至关重要？
临床数据标准对 EDC 与 non-EDC 数据均至关重要。Learn how study build…
Certara2024 年 4 月 25 日
