Our expertise — Step 1 of 7
Study design
The starting point of every study: setting the right strategy and preparing solid documents, tailored to the trial type and the countries involved.
What we do at this step
Strategic advice by trial type, including atypical or early-phase trials
Protocol & synopsis
ICF: writing, country adaptation, verification of French translations (FR, BE, CH)
Selection and set-up of tools: eCRF, CTMS, patient tools
Scope: Multi-country
The roles that can be involved at this step
Study design & documents — OKILYS consulting assignment
Strategic advice by trial type, protocol & synopsis, ICF (writing, country adaptation, verification of French translations), eCRF, CTMS, patient tools.
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.