To Support FDA Clearance
Premier Research has recently supported a fecal incontinence device manufacturer in performing a randomized controlled study to evaluate the safety and efficacy of the device in several European Union countries (UK, Germany and Sweden). The study data was used to obtain FDA regulatory approval.
Premier Research prepared and submitted Ethics Committee submission packages to support the study sites and completed the Competent Authority notifications on behalf of the sponsor in UK and Germany. Efficient communication between all involved parties resulted in timely EC/IRB and Competent Authority approvals.
Premier Research negotiated the financial portion of the Clinical Trial Agreements (CTA) with the investigational sites for some of the countries as well as performed payment tracking including patient travel compensation ensuring that payment requests from the investigational sites were promptly forwarded to the Sponsor.
The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor. Experienced CRAs also provided technical support to the sites during interventions, supporting the sponsor in dedicated technical data collection.
Premier Research prepared a study-specific Clinical Monitoring Plan. Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact with the sites and sponsor. Timelines for interim database closure were achieved.
Premier Research set-up and maintained a clinical investigation master file on behalf of the sponsor. Copies of site visit reports and other important communications were provided to sponsor on an ongoing basis. A complete master file was transferred to the Sponsor prior to the Pre-Market Application (PMA) submission, which was within two weeks of the last patient’s 12 month visit.
Safety and Compliance
Serious Adverse Event (SAE) reports were sent directly and simultaneously to Premier Research and the Sponsor. The Premier Research team ensured that complete SAE reports were prepared by the sites. Two site audits and a TMF audit was performed by the Sponsor with no major or critical findings reported.
With great team spirit, expertise and flexibility, Premier Research was able to meet the challenging demands that led to a successful PMA of the device.