Blog Archives

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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

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

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

Blog

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

Talk About ChemTalks

Oh, what a memorable meeting! Chemaxon’s first ever ChemTalks meeting in Basel on September 25,…

CertaraNovember 18, 2024

Blog

Mastering Value Storytelling with Data-Driven Stories

Unlocking the Power of Storytelling in Healthcare Communication In the realm of healthcare communication, persuasion…

CertaraNovember 14, 2024

Blog

PBPK Modeling to Support Bioequivalence & Generic Product Approvals

Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally…

CertaraNovember 12, 2024

Blog

Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting

On October 30, 2024, we hosted our Pinnacle 21 Enterprise (P21E) User Group Meeting (UGM)…

CertaraNovember 12, 2024

Blog

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

Talk About ChemTalks

Mastering Value Storytelling with Data-Driven Stories

PBPK Modeling to Support Bioequivalence & Generic Product Approvals

Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting

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