Strategic PRO advice
PRO research often takes place within the context of decisions about investment, pricing, trial design, market access and marketing. The design of our PRO research programs take full account of context and the fit with clinical research, regulatory and marketing needs. Our PRO team provides strategic advice, either as stand-alone consultancy, or with colleagues in Health Economics and Epidemiology as a part of broader market access, reimbursement, and in-market plans.
Our senior team in Oxford and Bethesda brings together opinion-leading scientific expertise, knowledge of marketplace and regulatory landscapes, together with consultancy skills and deep understanding of client needs. This team, led by Diane Wild, Kathy Beusterien, and Andrew Lloyd contributes to the scientific advancement of PRO development and debate on several fronts. Our deep understanding of how PRO issues connect with clinical development, regulatory affairs, marketing and labeling means we can provide PRO advice related to all stages of the drug development lifecycle. For more about the team and their recent publications click here.
The PRO team is able to provide strategic advice to clients in a wealth of areas including:
- Selection of PRO measures.
- PRO dossier development.
- Selection of approach for estimation of utility values.
- Regulatory affairs (including FDA and EMA).
- Endpoint model development.
- Marketing and labeling claims
- Market access and reimbursement strategies.
- Clinical trial and observational study design.