Rapid Post-Market Study Start-up
Case study
Post Market Case Studies
The Challenge
An unanticipated request from a notified body required a Fortune 500 medical device manufacturer to conduct a post-market study for a new cardiovascular device. To comply with the aggressive timeline specified by the notified body, the manufacturer required highly streamlined processes to initiate and execute the study.
The Solution
In close partnership with the manufacturer, ICON's Medical Device & Diagnostics Research group and its medical writers developed a study protocol and start-up plan that enabled execution several months faster than the typical study. The comprehensive plan included enrolment, compliance, site selection, contracting, and site initiation.
ICON simultaneously developed the study database using structures from prior studies to facilitate rapid programming, validation, and implementation. To mitigate delays during study start-up and contracting, ICON first utilised fast-enrolling sites in on going studies, followed by sites identified as capable of rapid start-up and efficient enrolment.
ICON's Value Add
The coordination and communication between ICON and the manufacturer allowed the study to start-up at unprecedented speed, meeting the notified body's aggressive timeline and protecting the commercial potential of the client's device. Long-standing relations between sites and ICON also contributed to efficient contracting and enrolment. The expertise of ICON's data management team accelerated the delivery of the database so that rollout occurred even before the unexpectedly early enrolment of the first patient.
- Reduced planned study costs by 25%
- Study protocol development
- Streamlined study start-up plan, including site contracting, study enrolment, and database development
The Outcome
ICON enroled the first patient five weeks after the initiation of the partnership -and a full month earlier than planned. In the following month, an additional four sites were initiated. The early site initiation and enrolment milestones were possible due to streamlined processes and close integration of ICON's team and the device manufacturer. In total, ICON's approach maximised efficiencies and reduced planned study costs by approximately 25%. ICON has continued to support the manufacturer's post-market studies in the years since this study.