Clinical Trial Monitoring

Julius Clinical Research is specialised in both pharmaceutical industry-sponsored and investigator-initiated trials. Julius Clinical Research has global coverage with local (Europe) and external CRAs from trusted parties. Our CRAs are dedicated to (commercial) timelines. Our team has monitored in- and outpatient studies and large, complex studies both nationally and internationally. 
The monitoring plan is devised after careful consideration of the trial’s specifics and includes:

•           Investigator/ Site Selection
•           Initiation Visits
•           Investigator Meetings
•           Patient Recruitment
•           Drug Accountability
•           SAE/ SUSAR Reporting
•           Schedule of Clinical Site Visits
•           The Intensity and Schedule of the Source Data Verification (SDV)

Monitoring can range from 100% on-site Source Data Verification (SDV) to central monitoring in conjunction with predefined procedures. A monitoring plan is always dynamic and can be revised, if required, in collaboration with the sponsor. 80% of the studies for which we carry out, the monitoring also involve our Data Management group, thus facilitating efficiency and quality of the output.