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.
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.
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Multidisciplinary Expertise to Support the Life Sciences Industry
Support for next-gen medical devices, wearable technologies, and pharmaceutical products.
Multidisciplinary Expertise for Pharmaceutical Testing & Modeling
Evaluate pharmaceuticals with pharmacodynamic modeling, clinical epidemiology, and pharmacoepidemiology studies.
Occupational and environmental health risk assessment and mitigation strategies to help protect employee health and wellness.
Real-World Data & Evidence Consulting
Leverage real-world data to improve healthcare decisions.
Chemical Toxicology & Health Risk Assessments
Exposure assessments, toxicity evaluations, and support for issues of toxicology and mechanistic biology.
Occupational & Environmental Epidemiology
Advanced epidemiological research and evidence-based insights from leading epidemiologists and biostatisticians.
Emerging Infectious Diseases
Scientific research, strategy, and tactics to support strategic planning related to numerous aspects of emerging infectious diseases.
Healthcare & Life Sciences Value & Outcomes Assessment
Strategic guidance for medical product value and access, including drugs, vaccines, and medical devices.
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.
Group Vice President and Principal Scientist
Senior Managing Scientist
Senior Managing Scientist