Seamless transition from PMA to post-market study
Case study
Post Market Case Studies
The Challenge
In the final weeks of a 600-patient study supporting a PMA application for an innovative orthopaedic device, the U.S. Food and Drug Administration (FDA) mandated that the manufacturer conduct a post-approval study (PAS). The FDA required that the PAS continue observation of all 600 patients who were enrolled in the PMA study.
The manufacturer consulted ICON, which had been providing full-service clinical coverage for the PMA study, to economically and seamlessly transition the PMA study participants to the mandated PAS.
The Solution
Plans for the PAS were rapidly established by the same ICON Medical Device & Diagnostics Research team that had been conducting the PMA study. The team then continued to conduct the PAS, preserving the existing project managers, clinical monitoring staff, database managers, and statisticians.
ICON's Value Add
Due to ICON's depth of clinical development experience and expertise across medical device classes and numerous geographies, ICON supported the seamless, efficient delivery of any pre- and post-market activities that the manufacturer required.
- Study protocol development
- Comprehensive study start-up planning, including compliance, site selection, contracting, site initiation, and enrolment
- Study database design and programming
The Outcome
The seamless approach maintained relationships trial site staff and did not incur the additional costs or delays normally associated with transitioning a PAS to a new CRO. Furthermore, diligent oversight of the PAS by ICON's team achieved high subject retention and compliance rates over the study's seven-year duration. The FDA also approved the PMA submission.