Medical device experts discuss four areas that can dramatically affect the cost and timelines of your clinical program
Changes in the US and EU medical device regulatory climate mean market access and approval is more dependent than ever on the collection of prospective clinical data. In an effort to try and reduce the time to market, companies may be tempted to rush through clinical trial design without seeking collaborative input from medical, regulatory and clinical operations experts. Such decisions can lead to significant delays in trial initiation/execution as well as an increase in costs which translates to lost market opportunity.
In this webinar, we explore four areas that can dramatically affect the cost and timelines of your clinical program and offer insight into elimination and control of these hidden landmines. A cardiovascular device case study will highlight these key points:
- Trial Design: The importance of maintaining sight of programmatic goals to avoid a “bloated” program
- Medical Writing: Seeking early strategic input on how data will be presented in the clinical study report
- Data management/biometrics: Bringing these “back-end” services forward as active participants in program development
- Site Selection: Maximizing use of historical site metrics to optimize selection and staging of site activation
