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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

Blog

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

Blog

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

Blog

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

Blog

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

CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

December 13, 2024 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…

CertaraDecember 13, 2024

Blog

Key development considerations for cell therapies

December 5, 2024 What is a “cell therapy”? Nearly every recent oncology clinical conference has…

CertaraDecember 5, 2024

Blog

CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know

December 3, 2024 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…

CertaraDecember 3, 2024

Blog

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

CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

Key development considerations for cell therapies

CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know

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