Safety and Pharmacovigilance
In a time of unprecedented acceleration in the development of novel therapies, ensuring safety is more critical than ever.
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.
CAR T safety considerations
Safety considerations related to CAR T-cells may impact both trial design and trial management, as the adverse events associated with immuno-oncology agents differ from those associated with cytotoxic therapies.
Safety for next-generation therapies
Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges.