Case study
Gastrointestinal - fecal incontinence
D-TARGET has recently supported a fecal incontinence device manufacturer with a feasibility study for a non-CE marked device with the objective to collect performance and safety information and develop procedural optimization for the device. The study was proposed to be conducted at up to 4 Centers within the European Union – Netherlands, Denmark and France.
Start up
D-TARGET successfully prepared and submitted Ethics Committee submission packages to support the study sites and did Competent Authority (CA) notifications to include Data Protection notifications submissions in Denmark, also premier Research were able to provide a quality control review service of translations associated with CA notifications and data protection submissions and develop and maintain a tracking system for regulatory submissions on behalf of the sponsor. Efficient communication between all involved parties resulted that there were no delays in receiving EC/IRB and CA approvals.
Site Selection and contract negotiation
The sponsor negotiated the financial parts of the Clinical Trial Agreements (“CTA”) with the Investigational Sites in the selected countries and D-TARGET kept track of the payments to the investigational sites to ensure payments were kept to a tiemly 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 well prepared sites.
Study management
D-TARGET prepared a study specific project guidelines document. Pro-active project management, progress tracking and monitoring were provided throughout the study, keeping close contact to the sites and the sponsor. The collection of paper case report forms (CRF’s) and other essential documents were subjected to quality control according to D-TARGET applicable quality standards. D-.
Study enrollment progressed at the expected rate. Having the CRA’s in close contact with study sites to assist in complying with the study, resulted in successful data collection, and monitoring. Data queries were addressed on site and resolved with the support of our experienced CRA’s.
Study documentation
Premier-Research set up and maintained a Clinical Investigation master file. Copies of Site Visit Reports, significant communications with the Investigational Sites and other essential study documentation were provided to the sponsor on an ongoing basis.
Safety and Compliance
Target safety department were also actively involved to assist the sponsor with CA vigilance reporting, the service provided by the experienced safety officers at D-TARGET was highly appreciated by the sponsor
Serious Adverse Event (“SAE”) reports were sent directly to D-TARGET and Sponsor. Subsequent vigilance reporting was prepared by D-TARGET safety department and submitted to the CA’s on behalf of the sponsor follwing their review and approval. D-TARGET PM, CRA’s and safety department collaborated closely with site Investigators to ensure that complete SAE reports were submitted by the Sites.
Conclusion
The unique collaboration of services offered by D-TARGET, combined with a great team spirit, readiness to perform, expertise, dedication and flexibility across many functional areas resulted in successfully delivering the study to the sponsor on time and on budget.