Our expertise — Step 4 of 7
Submissions
Securing approvals: a submission strategy tailored to the trial type, driven through to each site's greenlight.
What we do at this step
Submission strategy by trial type
EU Regulation: CTIS Part II
National regulations: ANSM & CPP, CNIL/HDH (France)
AFMPS & Ethics Committees (Belgium)
Initial submissions & amendments, through to greenlight (approval + signed contract)
Scope: European Union (CTIS) · France and Belgium
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 review of monitoring reports & TMF, KPIs/metrics, governance committees & escalation.
Quality
Deviation & CAPA management, preparation and support for audits & inspections.