Benefit-Risk Assessment

Do your product’s benefits outweigh its potential risks? More importantly, do you have the right data to credibly demonstrate this to regulators, payers, physicians, and patients?

You can rely on our experienced team to help you navigate the ever-evolving landscape of benefit-risk assessment and meet the requirements of regulatory and reimbursement stakeholders worldwide. Our integrated team of cross-functional experts can provide you with the guidance you need to synthesize, summarize, and confidently act on the relevant evidence for your product. We’ll help you build consensus within your organization to achieve a common understanding, increased transparency, and improved communication about your product’s benefit-risk profile.

A Structured Approach Tailored to Your Needs

Our teams have the expertise essential for developing a robust plan to assess benefits and risks. Once we have helped you develop a complete picture of your data, we can help you identify gaps to inform a strategy for possible new studies to include in your clinical development program and clarify appropriate post-approval activities. This includes:

The Value of Proactive Implementation

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Conducting credible benefit-risk assessments presents unique challenges because the data on risks and benefits are not usually measured together in the same studies or study populations, and are not often gathered in a real-world setting. Additionally, these measurements might not be collected in the same way in both short and long-term studies or using the same units. By engaging with our team early in the development lifecycle, we can help you account for these challenges and avoid costly re-work and lost time at a critical stage in your product’s development process—while helping you position your product with strong benefit-risk evidence that resonates with your audience.