Blog Archives

Blog

Patient Engagement and Patient Centricity Series Part II: Types of Patient Advocates

Nirpal Virdee, Synchrogenix’s Global Head of Transparency and Disclosure recently sat down with Trishna Bharadia,…

CertaraNovember 11, 2019

Blog

ICER’s Unsupported Drug Price Increase Report: An Analysis

We analyze the drug-price watchdog, ICER’s (Institute for Clinical and Economic Review) “Report on Unsupported…

CertaraOctober 24, 2019

Blog

Health Canada PRCI Guiding Principles and Observations

Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical…

CertaraSeptember 16, 2019

Blog

Common Questions about Define-XML and the Stylesheet

In this blog, we answer common questions about Define-XML and the Stylesheet, including all you…

CertaraAugust 22, 2019

Blog

Trends for Market Access, HEOR, and Real World Evidence

This blog reviews trends for using health economics and outcomes research and real-world evidence to…

CertaraMay 10, 2019

Blog

Real World Evidence Marches Forward in Drug Development

The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm…

CertaraMarch 20, 2019

Blog

Managing Immunogenicity Using Quantitative Systems Pharmacology

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving…

CertaraFebruary 22, 2019

Blog

7 Things to Know About the China Pharmaceutical Industry

China is the second largest pharmaceutical market in the world. Demand is likely to increase…

CertaraOctober 16, 2018

Blog

FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…

CertaraSeptember 27, 2018

Blog

Clinical Pharmacology Gap Analysis: Lessons Learned

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these…

CertaraAugust 10, 2018

Blog

Patient Engagement and Patient Centricity Series Part II: Types of Patient Advocates

ICER’s Unsupported Drug Price Increase Report: An Analysis

Health Canada PRCI Guiding Principles and Observations

Common Questions about Define-XML and the Stylesheet

Trends for Market Access, HEOR, and Real World Evidence

Real World Evidence Marches Forward in Drug Development

Managing Immunogenicity Using Quantitative Systems Pharmacology

7 Things to Know About the China Pharmaceutical Industry

FDA’s New ANDA Submissions Guidance: Key Points

Clinical Pharmacology Gap Analysis: Lessons Learned

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