Data monitoring and traceability of data is one of the key phases of clinical studies making it possible to ensure the proper conduct of a project with data collected in accordance with protocol and meeting quality procedures and current regulatory requirements.
CEMKA-EVAL has a Monitoring Department for non-interventional studies of medicinal products and medical devices.
Quality and organisational procedures have been defined by CEMKA-EVAL and are systematically applied.
The team is made up of project managers, assistant project managers and CRAs. For large-scale studies, CEMKA-EVAL also has a network of remote freelance CRAs.
In addition, CEMKA-EVAL has a call centre dedicated to health for setting up, monitoring and telephone follow-up of investigators and patients (CKM Health website)
Key points
- Recruitment of investigators and protocol briefing on site or by telephone
- Data collection on site, paper, by telephone or eCRF
- Centralised real-time monitoring of patient enrolments and follow-up
- Quality control of questionnaires (paper or eCRF)
- Patients recall
- Audit of enrolled patients’ files
- Regular study progress status
- Administrative management (doctor/hospital agreements, fees, etc.)
- Management and traceability of data entries
- Writing of newsletters and reporting
- Personalised contact with investigators throughout the study
