Do you need an experienced Clinical Research Professional for reviewing data for accuracy and completeness and perform source data verification? Do you need an experienced Clinical Research Professional who remains the first contact person of the site and facilitates the communication between sponsor and site during the course of the trial? An overview of services offered is shown here.
The monitoring services include
- Monitoring in trial phases 1-4 and NIS
- Site evaluation visits
- Site initiation visits, regular monitoring visits, close-out visits
- Co-monitoring for training purposes of your CRAs
- International Co-monitoring internationally for evaluation of CRA-performance
- Review of case report forms and source data verification
- Preparation and compilation of relevant site documentation for submission to IRB/IEC
- Negotiation of site contracts and budget
- Site file review and maintanance
- Preparation and follow-up on open issues of a monitoring visit
- Communication with trial sites
- Preparation of monitoring reports
- Preparation of site files for archiving
- Verification of site´s adherence to ICH/GCP-guidelines and to local law and regulations
- Adhere to all relevant SOPs of the client
- Ensure timelines are met
- Lead a team of CRAs
- Conduct investigator meetings
Location
- Monitoring: Germany and UK
- Co-monitoring: international
- Investigator meetings: international
