There are many approaches to clinical monitoring. Our monitoring philosophy is the following: Remote monitoring and on-site monitoring are integral parts of successful clinical monitoring. A data management group together with a quality assurance department and remote monitoring group permanently monitor the data for discrepancies, missing or invalid data, check calendars, unusual data patterns, rates of reporting, and compare the data with external sources to identify sites where a high probability of errors are high and a higher frequency of CRA visits is needed.

We consider every CRA visit to the site as a mini audit of the site. In close cooperation with the remote monitoring group, CRAs arrive for their visits armed with the following information:

• Data from all management trackers
• Any S(AE)s that happened at the site
• Lab results
• IVR/EDC status
• Any and all deviations from the protocol
• Informed Consent problems
• Patient eligibility questions
• Data capture issues
• Investigational Medicinal Product status

Along with ensuring the quality of monitoring visits, the quality of monitoring reports is a subject of continuous control. Monitoring reports are checked by Regional Managers and a Central QA department. You can be sure that every monitoring report reflects the accurate situation on site.