Successful pharmaceutical products require a robust risk management strategy that reduces risk to your patients, preserves access to treatment, and meets the requirements of the rapidly evolving regulatory environment.
During clinical development, we can help you assess potential risks associated with your product and also evaluate risks associated with drugs in the same class. Based on the data, you may identify target subpopulations for which your products will have more benefits, fewer risks, or both. Additionally, early risk evaluations provide information useful in developing risk minimization strategies and post-approval assessments.
Once your product is marketed, we can help you assess and evaluate risks in a real-world setting, so you are able to comply with risk management requirements, interpret adverse event data, and/or provide evidence-based risk-benefit information to patients, physicians, regulators, and other stakeholders.
Risk Management Plans
With an integrated approach to risk management plans—and in compliance with guidance from the FDA on Risk Evaluation and Mitigation Strategies (REMS) and EMA on European Risk Management Plans (EU-RMPs)—we follow a disciplined approach to help you mitigate risks and comply with regulatory expectations.
- Assess Risks and Benefits: Through scientifically-rigorous epidemiologic investigations, we help you define and understand potential risks associated with your products and identify populations of special concern. To put risks and benefits in perspective, we evaluate utilization and safety patterns of therapies and assess patient and physician preferences for treatment as they trade-off risks and benefits. The analyses and deliverables can guide your clinical development programs, regulatory submissions, and post-approval strategies.
- Develop and Implement Risk Management Plans: After assessing risks and benefits, we help you determine the most appropriate strategies for the risks of concern and the target population. This may include a formal REMS or EU-RMM that specifies tools—including patient and physician education or other methods—to improve safe use. We base our recommendations on current regulatory guidance, an analysis and review of current REMS and EU-RMM programs for similar drugs, and current trends in risk management plan submissions. As part the development process, we also engage stakeholders to comment on the proposed plan.
- Assess and Evaluate Risk Minimization Measures: As part of the assessment strategy, one or more study protocols are developed that consider the unique characteristics of the product, patients, and prescribers and the concerns of regulatory authorities. Evaluations may include drug utilization studies, which can often be conducted using existing health databases, chart abstraction, or a combination of the two. Assessment of knowledge, attitudes, and behavior (e.g., adherence to prescribing regiments) may require the conduct of surveys of patients and healthcare providers. For all studies, we use rigorous design and analytic methods to assure acceptance of results in the regulatory and scientific communities. Protocols and study reports from these types of studies are included in the EU PAS Register.
- Plan Modifications: As a result of your risk management plan evaluation, you will obtain the evidence needed to propose and gain approval from regulatory authorities to modify programs if changes are warranted. Proposed changes may include addition, modification, or removal of risk minimization measures; enhancement or reduction of the programs; or changes to the timetable for assessment, including eliminating assessment.