Operational Data Model (ODM) standard

How to Use CDISC’s ODM Standard for CRF Design Blog Post

Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium (CDISC) standards. This has largely been driven by regulation, with national regulators such as FDA…

Certara’s Simcyp Consortium Celebrates 25th Anniversary Blog Post

The pre-competitive scientific research consortium of top pharmaceutical companies remains a critical force in advancing qualified PBPK modeling and simulation to further drug development and regulatory decisions RADNOR, PA –…

Why cancer drug programs need human mass balance studies Blog Post

Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies in the clinical pharmacology package. This omission stems from the ICH S9 on nonclinical evaluation…