Launching a research site — whether a new standalone entity, a health system program, or a practice expanding into trials — involves far more than obtaining an FWA and finding a first study. This session lays out a practical playbook drawn from sites that have successfully made the leap. We'll cover the foundational decisions: legal structure and institutional relationships, staffing models and the realistic cost of building coordinator capacity, space and equipment requirements, SOP development, technology and eRegulatory infrastructure, and the financial modeling that determines whether a site survives its first three years. We'll also address business development — how new sites get onto sponsor and CRO radar without a performance track record, and what early metrics actually matter.

Takeaways

• Sequence the operational, regulatory, and financial steps of site launch
• Build a realistic staffing and cash flow model for the first three years
• Position a new site competitively with sponsors and CROs despite limited track record