Drug Safety & Risk Management

Evaluate, anticipate, and respond to safety-related issues regarding drug and biological products.

Whether it is signal detection, signal evaluation, or risk mitigation and evaluation strategies (REMS), maximizing safe use conditions is a significant, ongoing effort that is both logistically and scientifically challenging. Exponent's health science experts help pharmaceutical and biotechnology companies address these challenges.

Multidisciplinary expertise.  

Each phase of a product's lifecycle has its unique challenges, and Expoent has the multidisciplinary expertise to help you meet them. Our epidemiologists, biostatisticians, data scientists, human factors experts, toxicologists, and clinicians provide expertise at every stage  — from clinical studies, labeling, and surveys to post-marketing evaluations.  

Full lifecycle support.  

Changing regulatory requirements and expectations, new indications and off-label use, and demographic shifts all contribute to the continued evolution of the benefit-risk balance, increasing the importance of regularly evaluating drug safety and risk management programs and activities. 

Many tools can be used to optimize safe use conditions, beginning with product labeling. Enhanced pharmacovigilance, patient registries, and pharmacoepidemiology studies can be leveraged for signal detection and evaluation. 

Coming into the peri-approval period with a regulatory safety strategy can result in more effective and efficient risk management plans and scientifically feasible phase IV study designs.  Exponent epidemiologists can design individual safety studies and whole safety strategies, optimizing existing tools and methods and creating new methodologies.  

During post-marketing, regulatory milestones, safety signals, and new concerns may require action. This may involve conducting an epidemiologic study, developing or modifying an existing REMS, reassessing the feasibility of a phase IV study, or initiating a root cause analysis. Selecting the right tools and techniques requires factoring in urgency, efficiency, scientific validity, and humanistic factors such as unmet medical need.