Clinicology was tasked to restart and manage a Post-market Medical Device study which had been halted whilst under the management of another CRO. Clinicology was brought in to ‘rescue’ the study by resolving previously identified issues to minimise delays in restarting, whilst ensuring compliance and achieving targeted study timelines.
At the point Clinicology took over the study, it had been paused after recruiting less than 20 of the planned 450 participants, so it was significantly behind timelines. The study required a full overhaul of the protocol, Patient information sheet, study plans and associated documents as well as setting up a new EDC system. The sponsor required Clinicology to manage all aspects of the study setup, maintenance and close down.
Our experienced Project management team has a background in medical device studies and regulations which enabled us to identify risks and opportunities with the original study protocol, rewrite all essential documents and prioritise site selection and setup to ensure successful patient recruitment. Using a pragmatic approach, Clinicology was able to identify gaps in documentation and processes and quickly select an additional 11 sites to boost the overall total to 14 sites in the study.
In addition to site selection, the Clinicology team successfully transferred the study from paper based CRFs to EDC, working directly with the EDC vendor to update the CRFs in line with new protocol endpoints, building a functional EDC system utilising automatic query functions to reduce the burden on the CRAs and conducting testing and validation on the EDC build.
Another focus for the Clinicology team was to determine a process for device vigilance which was identified as missing from the previous CRO’s work. Our team has a high level of experience with the regulations and requirements for a post-market study and implemented a device vigilance process that was specific to the requirements for a device study.
Utilizing our vast network, we also engaged statistical support and medical writers to ensure the end to end running of the study was resourced appropriately.
Through successful project management, the study sites were brought back on track to be clinically ready to restart the project in line with sponsor device supply timelines. Our trusted team of CRAs, PMs, data managers and medical team remain focused on delivering the project on time and to a high standard of quality and are looking forward to guiding the sites to meet recruitment targets and overall study goals.
This case study illustrates our experience with managing medical device studies and has contributed to our growing reputation for success in the medical device sector.