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External Control Arms – The Case for a Standardized Lexicon and Toolkit Blog Post

Both the FDA and EMA have made statements that support the concept of using real world evidence (RWE) for regulatory decision-making. Historical control arms represent a way to take a…

Pinnacle 21 Clinical Data Management & Automation Suite Page

Increase the speed and quality of your clinical trial submission data with the Pinnacle 21 Clinical Data Management & Automation Suite.

Certara Completes Acquisition of Pinnacle 21 Blog Post

PRINCETON, N.J., Oct. 04, 2021 - Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the completion of the previously announced transaction to acquire Pinnacle 21, a leading...

Building a Robust Clinical Pharmacology & Model-Informed Drug Development Strategy for New Alzheimer’s Disease Drugs Blog Post

Alzheimer’s disease (AD) is one of the most common forms of neurodegenerative dementia in the United States. In fact, the Alzheimer’s Association predicts that by the year 2050, the number…

Preparing Vaccine Studies for Regulatory Submissions Blog Post

In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies for regulatory submissions.

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces? Blog Post

SDTM Trial Summary (TS) domain is essential for regulatory submission and is part of FDA rejection criteria. TS can be complex to implement with guidance spread across SDTMIG, FDA Study...

Pediatric Drug Development: Optimizing Extrapolation Blog Post

Optimizing the use of the extrapolation concept in pediatric investigational programs: Here are 4 key considerations. Drug development in pediatrics continues to be a substrate for the application of innovative...

Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children Blog Post

Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD). Guanfacine is primarily metabolized by...

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Blog Post

In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for adults with type 1 Gaucher disease. Eliglustat is an oral inhibitor of glucosylceramide synthase. It...

Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations Blog Post

The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc….

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