Integrated evidence generation planning

Solution

• Parexel proposed an approach to evidence planning that would take fuller advantage of RWD and other non-RCT data sources. This included:
  • Identifying research gaps in the product’s development lifecycle, including opportunities for using natural history data to create external control arms.
  • Developing a comprehensive plan detailing the use of RWE to support the needs of payers, healthcare professionals, patients, and governmental policymakers. This would include evidence regarding comparative value, product differentiation, and QoL outcomes.
  • Helping internal stakeholders reach consensus on RWD and RWE strategy and tactics.

Results

• Armed with an integrated evidence generation strategy to reduce development and reimbursement timelines, our client was positioned for efficient use of resources and to create a robust rationale for investment, with a clear path to achieving clinical and commercial potential.  
• Parexel delivers broad multidisciplinary support, which is particularly beneficial for biotech companies with relatively small product teams. In this case, our combined expertise in RWE, medical affairs, market access, and regulatory consulting resulted in holistic evidence planning to address the needs of multiple stakeholders.