of sponsor companies routinely solicit patient input into protocol design decisions.
Tufts CSDD sponsor survey, 2023.
of FDA drug and biologic applications approved between 2019 and 2023 included patient experience data in the benefit-risk framework.
Martin, JD et al. Therapeutic Innovation and Regulatory Science, 2025.
Patient input is most useful when it is tied to a decision: which endpoints to use, how a protocol should look, or what trade-offs patients would accept.
We help you identify which decisions would benefit, plan the research to inform them, and oversee it.
We report the findings with recommendations, documented so they can be referred to in protocols and submissions.
Where patient-facing materials are needed, we write them in plain language for your own review and approval process.
