CDISC SEND Updates Nonclinical Drug Developers Need to Know
In this blog, Peggy Zorn explores updates to the Standard for Exchange of Nonclinical Data…
Certara2026 年 4 月 6 日
FAQs on Developing EMA Policy 0070 Submissions
This blog answers audience questions posed during our RAPS webinar, How to Plan for a…
Certara2025 年 9 月 15 日
Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC
Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the…
Certara2025 年 2 月 19 日
Streamline Clinical Data Publication Under EMA Policy 0070
2025 年 2 月 14 日 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…
Certara2025 年 2 月 14 日
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
Certara2025 年 2 月 3 日
How to Validate Your Clinical Data Using FDA Validation Rules
2025 年 1 月 30 日 For clinical data managers, understanding clinical data validation and applying FDA validation…
Certara2025 年 1 月 30 日
Anonymization vs. Redaction of Clinical Trial Data
2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…
Certara2025 年 1 月 17 日
A Medical Writer’s Guide to Collaborative Authoring
Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…
Certara2024 年 11 月 22 日
How To Respond to Health Authority Questions
Your biotech company has just submitted the marketing application for your first drug product. It’s…
Certara2024 年 10 月 25 日
Why You Need an Integrated Development Plan
Learn about the Integrated Development Plan for successful drug development & its relation to the…
Certara2024 年 10 月 17 日
