Situation:
Division of large medical device company with no clinical capabilities needed to develop a post-market clinical strategy for several key product lines.
Solutions:
- Interviews with divisional and corporate stakeholder groups provided an understanding of objectives for the clinical program and new product value propositions.
- Detailed therapeutic area and market assessments served as a foundation for a program strategy that combined company-sponsored clinical studies and investigator sponsored research to optimize investment.
- Individual trial concept sheets with associated timelines and budgets were developed as part of the strategy and an interim was placed to manage program execution while they built an internal team.
- A revised process was initiated for review of investigator sponsored proposals to maximize successful execution.
- Communication between stakeholder groups was optimized through the initiation of management board review meetings.
Value:
Building a strategic plan for the post-market clinical program allowed the client to ensure that meaningful scientific data would become available at the right time in the product life-cycle. Improved internal communication and collaboration on a clinical strategy ensured the program would meet the needs of both the division and the corporation as a whole. A revised ISS review process helped minimize risk to the company and facilitated funding of proposals with the greatest likelihood of publication acceptance.