Post-Marketing Evaluation

Due to the inherent limitation of clinical trials, it is impossible to identify all possible safety risks for a particular drug before it is approved. Once a drug reaches the market and more patients are exposed to a drug in real world settings, safety issues may emerge, making it important to monitor the safety and risk-benefit profile of drugs post-approval. Our pharmacovigilance, pharmacoepidemiology and health outcomes experts can assist you with your critical post-approval safety monitoring needs.

Pharmacovigilance and Post-Marketing Risk Assessment
Our Drug Safety and Pharmacovigilance group has extensive experience with adverse event reporting and monitoring for drugs in clinical development and after approval. The emergence of post-marketing adverse events can lead to new safety signals, which may in turn require a reevaluation of a product’s risk-benefit profile and risk management plan. Good case reporting practices are key to making accurate post-marketing assessments and our safety team can ensure that your case reports are accurate and complete so you can make better safety and risk management decisions.

Observational Studies for Post-Marketing Risk Assessment
Post-approval safety can be monitored with a variety of observational studies, including epidemiological studies, database studies, patient registries and patient/physician surveys. These studies are used to monitor for new safety signals, particularly for events observed in clinical trial results and events of special interest that have certain product/patient characteristics. They can also be used to follow up on potential signals in order to help confirm or refute them, or to identify the risk factors for the events. We have extensive experience in all of these observational study methods, so you can be sure that the most appropriate method is recommended and implemented based on your unique needs. The results can then help recharacterize your products risk-benefit profile and guide subsequent action.

Understanding Safety Signals and Taking Appropriate Precautionary Measures
Once a safety signal is identified and further investigated by post-approval observational studies, our qualified experts interpret the findings to determine the correct next steps. Collectively, the findings may or may not indicate a causal relationship between the drug and an adverse event, and the resulting recommendation could have huge consequences if incorrect. A valuable drug may be inappropriately restricted, or an important safety risk may go unattended. If sufficient evidence is found to suggest a drug causes an adverse event, additional regulatory reporting and/or precautionary measures may be required, such as changing product labeling or implementing a RiskMAP. You can count on our experts to provide scientifically-based risk assessments and guidance so you can be confident about your risk management decisions.