Blog Archives

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U.S. International Reference Pricing: Global Implications and Pharma Strategy

Unintended global fallout of international reference pricing: How the U.S. Most Favored Nation policy could…

CertaraOctober 6, 2025

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Essentials of Model-informed Drug Development in Oncology

Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…

CertaraOctober 6, 2025

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Best Practices in Clinical Pharmacology Gap Analysis

September 19, 2025 Submitting your New Drug Application (NDA) to the FDA is the ultimate…

CertaraSeptember 19, 2025

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FAQs on Developing EMA Policy 0070 Submissions

This blog answers audience questions posed during our RAPS webinar, How to Plan for a…

CertaraSeptember 15, 2025

Blog Knowledge Base

What is a Loading Dose?

September 10, 2025 Understanding how drugs reach steady-state levels is essential for safe and effective…

CertaraSeptember 10, 2025

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Dose Optimization using the Gene Therapy Virtual Twin® Platform

This blog explains how using the Gene Therapy Virtual Twin® Platform can help optimize dosing…

CertaraSeptember 9, 2025

Blog

Clinical Trials Regulation (EU) No. 536/2014 – The Impact on Annual Safety Reporting

Stay compliant with EU rules for the pharmaceutical industry. Learn about annual safety reports and…

CertaraSeptember 5, 2025

Blog

Best Practices for Safety Narrative Writing in Clinical Research

Explore the patient narrative format in medical writing and why narrative writing in clinical research…

CertaraSeptember 5, 2025

Blog

Top 5 Recommendations for Successful Interactive Value Messaging

August 22, 2025 Over the past two decades in health economics and market access, I’ve…

CertaraAugust 22, 2025

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Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus

Streamline your SDTM mapping with Pinnacle 21 Enterprise. Discover how innovation and efficiency enhance data…

CertaraAugust 13, 2025

Blog

U.S. International Reference Pricing: Global Implications and Pharma Strategy

Essentials of Model-informed Drug Development in Oncology

Best Practices in Clinical Pharmacology Gap Analysis

FAQs on Developing EMA Policy 0070 Submissions

What is a Loading Dose?

Dose Optimization using the Gene Therapy Virtual Twin® Platform

Clinical Trials Regulation (EU) No. 536/2014 – The Impact on Annual Safety Reporting

Best Practices for Safety Narrative Writing in Clinical Research

Top 5 Recommendations for Successful Interactive Value Messaging

Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus

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