Monitoring

SSS International Clinical Research provides well trained professional monitoring staff. The mean number of sites we are monitoring at a time is about 200-250. We can therefore provide sponsors with the necessary monitoring resources for small, medium and large Clinical Trials in Europe.

Site Selection
Potential investigators are visited to discuss the planned project and to qualify the sites for their ability to perform studies according to Good Clinical Practice (Pre-Study Site Assessment).
Due to our excellent contacts to many potential investigators in Europe, SSS International Clinical Research can provide its sponsors with the best conditions for fast site recruitment and excellent patient recruitment.

Study Initiation
The second on-site visit is performed at the beginning of the study (Study Initiation Visit). The aim of this visit is to review the investigator’s brochure and protocol in detail with the investigator and staff who are to be involved in the study and to discuss all study procedures with the investigator and his/her research team.

Monitoring Visits
As studies progress, routine site visits are performed to monitor for adherence to Good Clinical Practice. The timing of these visits is determined by the size of the study, rate of patient recruitment, and sponsor needs. Usually sites are visited every 4 to 6 weeks. During the on-site visits Clinical Research Associates of SSS International Clinical Research document that correct procedures are being followed and that scientific and ethical conduct of the study is uncompromised. The monitors not only assure the quality of the clinical data and documentation being produced at the site, but also identify potential problem areas, design approaches to prevent problem development, and suggest methods to increase the efficacy of site staff in performing the duties related to the study. After each visit, a monitoring report is prepared covering all relevant aspects of the visit including e.g. results of source data verification, and results of drug accountability checks. These and other administrative reports keep clients apprised of the status and progress of individual clinical trials. Usually all reports are provided to the sponsor on an ongoing basis.