Clinical Trial Management

We have learnt from our experience that three elements are utterly inseparable within a successful Study Monitoring:

• An effective coordination assured by a Project Leader whose role is twofold: liaising between the Popsicube-Fovea team involved in the study (CRAs, Quality Assurance and, if necessary, the Biometry Department) and the Sponsor from one side, and managing the CRAs team assigned to the study from the other side
• Privileged relationships with investigators networks, thus guaranteeing inclusion deadlines and the reliability of the collected data
• The systematic implementation of a Quality Assurance Plan whose aims are to define precisely and specifically the procedures, the sample forms and the reporting documents to be used

We are in a position to manage the complete or partial monitoring aspects of any study:

• Realization of the preliminary feasibility study
• Recruitment of the coordinator and investigators (hospital and private practice)
• Management of regulatory procedures (Regulatory Authorities files, information to Professional Bodies) as well as administrative procedures (investigators’ contracts, hospital conventions…)
• Organizing and overseeing investigators’ material (constitution and delivery of the investigators’ kits)
• Pre-selection of the centers
• Implementation of the study (organizing and supervising investigators’ meetings, initiation visits)
• Monitoring of the study (follow up visits and phone contacts, remote monitoring)
• Closure of the centres
• Management of serious adverse events
• Financial management of the study (investigators fees, hospital costs overruns…)

Furthermore, Popsicube-Fovea provides real-time editing of all the documents required to keep the Sponsor constantly informed and updated: anticipated schedule of visits, progress report of inclusions per centre, detailed reports of visits and phone contacts, management of therapeutic units per centre, budgetary breakdown per centre…

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