Navigate the Evolving Safety Landscape  

Expectations of global regulators are increasing regarding ongoing, long-term safety assessments, signal detection and refinement. The right strategy to continually evaluate product safety in your clinical trials, through regulatory review and entering the post-marketing setting is complex. Local market regulations are ever-changing. Technologies to intake, track and manage workflow are getting more sophisticated. Are you ready?

Leverage our PV checklist to guide internal conversations around your organization's safety strategies:

  • Safety Systems
  • Data Migration
  • Global Case Processing
  • Regulatory Reporting
  • Period Reporting
  • Products to Enhance Operational Delivery
  • Signal Management & more

Our Safety Experts

In the last three years, our safety and pharmacovigilance experts have helped more than 60 companies address their safety needs by implementing and managing over 84 PV programs. Our broad experience includes drug, cellular gene therapy, vaccines, medical devices and over-the-counter products.

Natalie O'Donnell

Corporate Vice President, REMS, Safety and Strategic Engagement

Christine Mandell

Clinical Project Manager Safety

Geraldine Aubes

Senior Director, Pharmacovigilance, Safety