Our expertise — Step 6 of 7
Conduct & monitoring
The heart of the study: recruiting, monitoring the sites, safeguarding data quality and keeping the study on track.
What we do at this step
Patient recruitment & recruitment boosting
Monitoring visits — on site or remote (RBM, DCT)
Close communication with sites & escalation
Data quality & eTMF
Risk & deviation management
Scope: Monitoring: France and French-speaking countries · rest of follow-up: multi-country
The roles that can be involved at this step
Investigator site monitoring — Senior CRA
Selection visits, initiation, on-site and remote monitoring, recruitment boosting, site close-out.
Clinical operations coordination — Clinical Trial Lead (CTL)
Steering clinical operations, coordinating CRA teams across countries, sponsor reporting.
Investigator site support — Study Coordinator
Support to site teams: patient visits, eCRF data entry, samples and supplies management.
Project management — project-lead tasks carried as SSU Lead & Clinical Trial Lead
End-to-end project management: planning, budget, risks, sponsor/CRO/site interfaces.
Clinical Oversight — Clinical Oversight Manager
Sponsor-type oversight of vendors (ICH-GCP): oversight plan, sponsor review of monitoring reports & TMF, KPIs/metrics, governance committees & escalation.
Quality
Deviation & CAPA management, preparation and support for audits & inspections.