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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

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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

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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

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Key development considerations for cell therapies

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

CertaraDecember 5, 2024

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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

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De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development

November 22, 2024 In drug development, early strategic planning is crucial to minimizing risks, optimizing…

CertaraNovember 22, 2024

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A Medical Writer’s Guide to Collaborative Authoring

Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…

CertaraNovember 22, 2024

Blog

Top Three Insights from Certainty Europe

The first European Certainty Conference for the Certara Client Community in Mainz Germany was full…

CertaraNovember 21, 2024

Blog

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

De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development

A Medical Writer’s Guide to Collaborative Authoring

Top Three Insights from Certainty Europe

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