Our expertise — Step 2 of 7
Site selection
Choosing the right countries and the right investigator sites: much of the study's future recruitment is decided here.
What we do at this step
Country and investigator site selection
Feasibility assessments
Selection visits
Creation of SOPs and internal processes
Follow-up and review of selection reports
Oversight of outsourced selection activities
BID
Scope: Multi-country · Worldwide
The roles that can be involved at this step
Start-Up — SSU & Contract Specialist
Feasibility, collection of essential documents, contract & budget negotiation (Convention Unique, Pharma.be), ARS & CNOM notifications, submissions through to greenlight.
Start-Up coordination — SSU Lead
SSU team management, harmonised practices, tracking of start-up milestones across countries.
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 follow-up and review of selection reports & TMF, KPIs/metrics, governance committees & escalation.
Quality
Deviation & CAPA management, preparation and support for audits & inspections.