We help our clients develop and implement robust risk management strategies for their products. When you work with us, you benefit from our understanding of the rapidly evolving regulatory environment for risk management. Our goal is always to help you meet regulatory requirements and reduce risk to patients, while preserving access to treatment.
We recommend that risk management be part of your drug development strategy from early clinical trials through the post-marketing period. At each stage in your product's life cycle, we can help you incorporate risk management into your planning process and help you achieve your objectives.
Pre-Approval Risk Assessment
When your product is in clinical development, we can help you better understand its risks and risks associated with drugs in the same class. Our evaluation may help you better target subpopulations for whom the drug will have more significant benefits, fewer risks, or both. Moreover, the early and continuing evaluation prior to approval can help develop risk minimization strategies and evaluation for the post-approval assessment.
Post-Marketing Risk Assessment
After a drug has been approved, the patients exposed to it may include subpopulations that were not included in clinical trials. Also, more patients will be exposed and possibly for longer periods of time than in clinical trials. In this real-world setting, safety issues may emerge, making it important to monitor the safety and risk-benefit profile of drugs post-approval. Our pharmacovigilance and pharmacoepidemiology experts can assist you with your critical post-approval safety monitoring needs. We will help you stay in compliance with safety reporting requirements and help you interpret the adverse event data so that you are prepared to provide accurate, evidence-based risk-benefit assessments to patients, physicians, regulators, and other stakeholders.
Risk Management Plan (RMP)
We can help you prepare formal risk management plans (RMPs) that comply with guidance from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
We conduct thorough epidemiologic investigations to help you define and understand potential risks associated with your products and we identify populations of special concern. To put risks and benefits in perspective, we evaluate utilization and safety patterns of therapies. And we assess patient and physician preferences on trade-offs between risks and benefits of treatment. We provide analyses and deliverables that can help guide your development programs, regulatory submissions, and post-approval strategies.
To help you assess risks and benefits, we implement studies that include:
Retrospective and prospective epidemiologic studies, including database studies
Large safety trials and registries
Conjoint analysis of risk-benefit trade-offs (preference studies)
Literature syntheses, including sections in RMP documents
Population surveys of physicians and patients, including REMS surveys
After assessing your product's risks and benefits, within their clinical context, we help you determine the most appropriate strategies to manage potential risks. This may include a formal REMS or EU-RMP that specifies tools ranging from education programs to performance-linked access systems.
We select and engage stakeholders to help develop and review the plan. A well-conceived plan, with clear goals, objectives, and an evaluation strategy, has the greatest likelihood of success in minimizing risk while ensuring access to needed therapy for patients.
We develop deliverables and design studies according to guidance put forth by the following organizations:
ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)
We design and implement assessment plans to evaluate the effectiveness of REMS or other RMPs. We prepare reports that will meet regulatory requirements for assessments of your RMPs.
We have experience with state-of-the-art tools to assess REMS and other RMPs, including the following methods:
Cognitive evaluation of educational materials
Surveys of prescriber and patient knowledge, attitudes, and practices
Prescription compliance studies using claims database and prescribing data
Our assessment and evaluation of your REMS and other RMPs provide you with evidence that allows you to propose and gain approval from regulatory authorities to modify your programs. Proposed changes may include addition, modification, or removal of a medication guide, patient package insert, communication plan, or elements to assure safe use (ETASU) and enhancement or reduction of the programs or changes to the timetable for assessment, including eliminating assessment.
