EU CTIS: Europe’s New Clinical Trial Information System
The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…
Certara2025 年 2 月 10 日
Measuring metabolites in index clinical DDI studies
2025 年 2 月 7 日A key drug development safety consideration is whether the drug candidate will interact…
Certara2025 年 2 月 7 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
Best Practices for International Pharma Content Roll-Out
2025 年 1 月 31 日 Pharmaceutical market access, sales, and field teams rely on high-quality, effective content…
Certara2025 年 1 月 31 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
Achieve Clinical Data Transparency with the 4 Cs of Collaboration
In this blog, we look at how you can enhance clinical data transparency and make…
Certara2025 年 1 月 15 日
Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters
2025 年 1 月 10 日 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…
Certara2025 年 1 月 10 日
CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of
2024 年 12 月 13 日 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…
Certara2024 年 12 月 13 日
Key development considerations for cell therapies
2024 年 12 月 5 日 What is a “cell therapy”? Nearly every recent oncology clinical conference has…
Certara2024 年 12 月 5 日
