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
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
What is a Loading Dose?
Learn what a loading dose is, why it's vital for reaching therapeutic drug levels swiftly,…
CertaraSeptember 10, 2025
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
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
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
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
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
Regulatory Operations Best Practices for Health Canada Submissions
Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…
CertaraAugust 11, 2025
Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development
Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…
CertaraAugust 6, 2025
