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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…

CertaraFebruary 19, 2025

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Streamline Clinical Data Publication Under EMA Policy 0070

February 14, 2025 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…

CertaraFebruary 14, 2025

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EU CTIS: Europe’s New Clinical Trial Information System

The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…

CertaraFebruary 10, 2025

Blog

Measuring metabolites in index clinical DDI studies

February 7, 2025A key drug development safety consideration is whether the drug candidate will interact…

CertaraFebruary 7, 2025

Blog

Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

We look at the growing regulatory trend of rolling NDA and BLA submissions to help…

CertaraFebruary 3, 2025

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Best Practices for International Pharma Content Roll-Out

January 31, 2025 Pharmaceutical market access, sales, and field teams rely on high-quality, effective content…

CertaraJanuary 31, 2025

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How to Validate Your Clinical Data Using FDA Validation Rules

January 30, 2025 For clinical data managers, understanding clinical data validation and applying FDA validation…

CertaraJanuary 30, 2025

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Anonymization vs. Redaction of Clinical Trial Data

January 17, 2025 The vernacular for disclosing pharmaceutical clinical trial results to the public may…

CertaraJanuary 17, 2025

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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…

CertaraJanuary 15, 2025

Blog

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters

January 10, 2025 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…

CertaraJanuary 10, 2025

Blog

Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC

Streamline Clinical Data Publication Under EMA Policy 0070

EU CTIS: Europe’s New Clinical Trial Information System

Measuring metabolites in index clinical DDI studies

Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

Best Practices for International Pharma Content Roll-Out

How to Validate Your Clinical Data Using FDA Validation Rules

Anonymization vs. Redaction of Clinical Trial Data

Achieve Clinical Data Transparency with the 4 Cs of Collaboration

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters

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