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Machine Learning for PK/PD Modeling in Drug Development

Pharmacometricians can use machine learning for PK/PD modeling to help them characterize the safety and…

CertaraMarch 4, 2025

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How the US FDA MIDD paired pilot program helps sponsors

February 28, 2025 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…

CertaraFebruary 28, 2025

Blog

Gain Nonclinical Drug Safety Insights with Real-Time Data Analysis

February 24, 2025 Efficient drug development relies on informed decision-making. For toxicologists, having timely access…

CertaraFebruary 24, 2025

Blog

The History of Pinnacle 21

February 21, 2025 It was late 2007. Mad Men was the hottest show on TV.…

CertaraFebruary 21, 2025

Blog

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

Blog

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

Blog

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

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

Machine Learning for PK/PD Modeling in Drug Development

How the US FDA MIDD paired pilot program helps sponsors

Gain Nonclinical Drug Safety Insights with Real-Time Data Analysis

The History of Pinnacle 21

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

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