Development
Getting a site to first patient in, on a real timeline.
Site management keeps a live site performing. Development is the phase before that — selection, approval and initiation — where most studies actually lose their timeline.
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Regulatory & ethics submission support
Preparing and tracking the site-level submissions each country requires, and collecting the essential documents a site needs before it can open — in parallel across Romania, Moldova, Bulgaria and Georgia rather than one country at a time.
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Site initiation
Training site staff on the protocol and study-specific SOPs, and confirming the site is genuinely inspection-ready — not just paper-ready — before the first patient is screened.
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Contracts & budgets
Negotiating site contracts and budgets against a timeline the site can actually hold, rather than a template that gets renegotiated three months in.
Site initiation
Inspection-ready, not just paper-ready.
Every credential and essential document is checked in person before a site opens — the same standard a regulator will hold it to on the first monitoring visit.
Why it's a separate step
Start-up is where timelines actually break.
Most delays a sponsor feels months into a study were decided at start-up: a site that agreed to a budget it couldn't really run on, or staff trained on a protocol they hadn't fully understood. We treat development as its own deliverable, with its own sign-off, before a site moves into ongoing management.
See ongoing site management- Typical scope
- Site selection confirmation, ethics/regulatory submission, essential document collection, initiation visit, staff training, contract & budget sign-off.
- Runs alongside
- Feasibility (site selection) and, once a site is live, site management — the same team carries context across all three, nothing re-explained at handover.
Have a site that needs to open faster?
Send us the synopsis. You get a feasibility read on country fit, site availability and realistic enrolment within five working days.