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Technical assistance
Whereas our competitors like to use wording such as «Outsourcing» or even «Control», we prefer to talk about Technical Assistance. Indeed, we consider Technical Assistance to be a distinct, bone fide profession, with its own specific functions, procedures and quality standards. Each person involved (Data Entry Operator, Data Manager, Statistician, Clinical Research Associate, Project Leader) retains a strong, operational and hierarchical link with FOVEA through a referent.
Thus, in the field of Monitoring, the Clinical Research Associate works under a CRAs Manager whose role is to:
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Provide technical assistance whenever the CRA is confronted with a problem |
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Ensure that our service specifications are respected |
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Validate all reporting elements sent to the Sponsor |
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Pay on-site co-monitoring visits |
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Control the regular updates of the Sponsor's Clinical Studies Monitoring program |
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Execute a permanent training program with FOVEA's internal teams (Biometry, Quality Assurance) as well as external teams |
These responsibilities are carried out on a daily basis, and not merely during a single, day-long meeting every month. Since FOVEA looks after and manages the logistic aspects of the monitoring process, the Sponsor is therefore free to concentrate on the scientific and medical aspects of the study.
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