Search

Site map

Legal

Monitoring

We have learnt from experience that 3 elements are utterly inseparable from a successful Study Monitoring:

	An effective co-ordination assured by a Project Leader whose role is twofold: assuring the liaison between the FOVEA team involved in the study (CRAs, Quality Management and, if necessary, the Biometry Department) and the Sponsor (hosting Customer/FOVEA meetings, compiling follow-up reports), as well as managing the CRAs team assigned to the study (co-monitoring visits, hosting internal meetings)
	Privileged relationships with investigators networks, thus guaranteeing inclusion deadlines and the reliability of the collected data
	The systematic implementation of a Quality Management Plan whose aims are to define precisely and specifically the procedures, the sample forms and the reporting documents which are to be used

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

	Execution of the preliminary feasibility study
	Recruitment of the co-ordinator and investigators (hospital and town)
	Management of regulatory procedures (dossier for the Regulatory Authorities, information to the Professional Bodies...) as well as administrative procedures (investigators' contracts, hospital conventions...)
	Organising and overseeing investigators' equipment (constitution and delivery of the investigators' sample kits)
	Preselection of the centres
	Implementation of the study (organising and supervising investigators' meetings, initiation visits)
	Monitoring of the study (periodic visits and telephone contacts, telephone assistance through a toll-free number)
	Dismantling and closing down the centres
	Management of serious adverse events
	Financial management of the study (handling and settling investigators fees, handling and settling hospital cost overruns...)

Furthermore, FOVEA has developed Seven_ARC, an in-house software program specifically designed to monitor Clinical Trials. Seven_ARC allows real-time editing of all the documents required to keep the Customer constantly informed and updated: anticipated schedule of visits, progress report of inclusions per centre, detailed reports of visits and telephone contacts, case report forms breakdown, compatibility between the therapeutic units per centre, budgetary breakdown per centre,...

ON-LINE STUDIES