Safety and Pharmacovigilance

In a time of unprecedented acceleration in the development of novel therapies, ensuring safety is more critical than ever.

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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.

WHITE PAPER

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.

PREMIER PERSPECTIVE

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.

Related Services

Safety and pharmacovigilance is part of a wide range of service offerings that include medical and regulatory affairs, study design, and global compliance. Follow the links below to learn more about how clients gain from our specialized expertise.

Medical and Regulatory Affairs

Study Design

Global Compliance

Check out our resource center

Our experts have developed an extensive library of white papers, case studies, blogposts, and other informative resources.

PREMIER INSIGHTS

PREMIER INSIGHTS

WHITE PAPERS

WHITE PAPERS

WEBINARS

WEBINARS

VIDEOS

VIDEOS

PODCASTS

PODCASTS

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