Safety and Pharmacovigilance

Your project demands a new level of safety rigor

Full-time access to our scientists, healthcare professionals, and data managers

Our scientists, healthcare professionals, and data managers work with you to provide safety support at every stage of product development.

Key considerations for developing an early phase trial:

• Use dose-finding trial designs with the goal of establishing a biologically effective dose
• Use pharmacokinetic or pharmacodynamic endpoints from preclinical models to predict a range of biologically active doses
• Use adaptive trial designs to gain improved, early insight into treatment effect
• Identify and select investigators and sites that have experience in recognizing, characterizing, and monitoring adverse events
• Rigorously manage safety review activities

Database setup, safety management plans, and serious adverse event (SAE) narrative templates are scaled to your needs, so you don’t pay for what you don’t need. And in coordination with our medical and data management professionals, we provide everything from a single-study solution to a full portfolio database that’s accessible to your team at all times.