Case study
Gastrointestinal - fecal incontinence
D-TARGET has recently supported a fecal incontinence device manufacturer in performing randomized controlled study to evaluate the safety and efficacy of the device in several European Union countries (UK, Germany and Sweden). The study data were used to obtain FDA regulatory approval.
Start up
D-TARGET prepared and submitted Ethics Committee submission packages to support the study sites and did Competent Authority notifications on behalf of the sponsor in UK and Germany. Efficient communication between all involved parties resulted that there were no delays in receiving EC/IRB and Competent Authority approvals.
Contract negotiation
D-TARGET negotiated the financial parts of the Clinical Trial Agreements (“CTA”) with the Investigational Sites in some countries and kept track of the payments to the investigational sites including the compensation for patient travel ensuring that payment requests from the Investigational Sites are promptly forwarded to Sponsor afterwards.
Site Initiation
The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor. Selected, experienced CRAs also provided technical support to the sites during interventions, supporting the sponsor in dedicated technical data collection.
Study management
D-TARGET prepared a Study specific Clinical Monitoring Plan. Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact to the sites and the sponsor. Timelines for interim database closure were achieved.
Study documentation
D-TARGET had set up and maintained a Clinical Investigation master file. Copies of Site Visit Reports and other important communications with the Investigational Sites were provided to sponsor on an ongoing basis. A complete master file, as of that date was transferred to Sponsor prior to the Pre-Market Application (“PMA”) submission, i.e. within two (2) weeks from the last patient’s twelve (12) month visit. The remaining master file was transferred upon the completion of the Services