Experience in action · 2024
Fact Sheet #1
Fast-tracking a multi-country study in rare disease
Project profile
A small biotechnology company preparing a rare-disease study across five EU countries.
The client had limited internal resources and regulatory experience for a complex multi-country study. BeEasy built a decentralised operating model using its network of small and medium-sized CROs and specialist vendors, with clear Sponsor oversight and country-level coordination.
BeEasy services used
- Global Research Alliance Service
- Study Start-Up Service
- Strategic Consulting
Selected outcomes
Evidence of coordinated delivery.
- First site activated within nine weeks.
- No regulatory resubmission rounds reported in the fact sheet.
- Local and EU regulatory requirements addressed across the selected countries.
- The network model reduced delay while preserving Sponsor control.
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