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Centers of Excellence in Pharma: Driving Efficiency and Innovation

March 25, 2025 In today's fast-paced pharmaceutical industry, Centers of Excellence (CoEs) have become vital…

CertaraMarch 25, 2025

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Protect Confidential Information in Investigational Drug Submissions

March 20, 2025 Health regulatory agencies require pharmaceutical companies to protect study participants’ personal information…

CertaraMarch 20, 2025

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FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

March 19, 2025 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…

CertaraMarch 19, 2025

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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

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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

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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

Centers of Excellence in Pharma: Driving Efficiency and Innovation

Protect Confidential Information in Investigational Drug Submissions

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

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

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