Gastrointestinal/Fecal Incontinence Feasibility Trial

Premier Research recently supported a fecal incontinence device manufacturer with a feasibility study for a non-CE Marked device. The objective was to collect performance and safety information and develop procedural optimization for the device. The study was conducted at centers within the European Union (Netherlands, Denmark and France).

Premier Research successfully prepared and submitted Ethics Committee submission packages to support the study sites and completed the Competent Authority (CA) notifications including the data protection notifications submissions required in Denmark. Premier Research also provided a quality control review of the translations associated with CA notifications and data protection submissions and developed and maintained a tracking system for regulatory submissions on behalf of the sponsor. Efficient communication between all involved parties resulted in no delays for EC/IRB and CA approvals.

Site Selection and Contract Negotiation
While the sponsor negotiated the financial parts of the Clinical Trial Agreements (CTA) with the sites, the Premier Research team tracked site payments to ensure payments were made in a timely manner.

The sites were initiated and trained by our experienced monitors (CRAs) in cooperation with the sponsor. The combined approach to the initiation visits resulted in well trained and prepared sites.

Study Management
Premier Research prepared a study specific project guidelines document. Pro-active project management, progress tracking and monitoring were provided throughout the study, keeping close contact with the sites and sponsor. The collection of paper case report forms (CRFs) and other essential documents were subjected to a quality control review according to Premier Research applicable quality standards.

Study enrollment progressed at the expected rate. The CRAs maintained close contact with the study sites to assist in complying with the study which resulted in timely data collection. Data queries were addressed on-site and resolved with the support of our experienced CRAs.

Study Documentation
Premier Research set-up and maintained a clinical investigation master file. Site visit reports, significant communications with the sites and other essential study documentation were provided to the sponsor on an ongoing basis.

Safety and Compliance
The Premier Research safety department was actively involved in assisting the sponsor with CA vigilance reporting. The service, provided by the experienced safety officers, was highly appreciated by the sponsor.

Serious Adverse Event (SAE) reports were sent directly to Premier Research and the sponsor. Subsequent vigilance reporting was prepared by the Premier Research safety department and submitted to the CAs on behalf of the sponsor following their review and approval. The Premier Research Project Manager, CRAs and safety department collaborated closely with the investigators ensuring complete SAE reports were submitted by the sites.

The unique service collaboration offered by Premier Research, combined with a great team spirit, readiness to perform, expertise, dedication and flexibility resulted in successful on-time and on budget study delivery.

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