Monitoring and quality assurance

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