Full Study Service:
Comprising the selection of study sites, ethics committee approvals and regulatory notifications, study initiation, recruitment of the required eligible patients, monitoring with source data verification (SDV) and drug accountability, web-based data management, data cleaning until frozen data base is achieved, statistical analysis, final study report writing and publication.
Patient recruitment plus e-data management:
Comprising the selection of study sites, ethics committee approvals and regulatory notifications, study initiation, recruitment of the required eligible patients, web-based data management, data cleaning until frozen data base is achieved.
The limited monitoring required in e-trials, mainly focussing on source data verification (SDV) and drug accountability can be performed by the Sponsor.
Patient recruitment:
Comprising the selection and identification of qualified sites for a study and assuring the recruitment of the required numbers of eligible patients.
Patient recruitment feasibility surveys:
Comprising the analysis and report of the incidence, distribution and seasonal variability of a required patient population, according to the study's specific selection criteria. The description of the patient population according to protocol specifics, such as demographics, concomitant diseases and medication, in order to allow accurate planning for a later study performance
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