Study Startup & Site Activation

Study startup and site activation set the pace for the rest of the trial. Delays in contracts, ethics approval, essential documents, or investigational product release push first-patient-in and compress every later milestone. Viltis supports sponsors and CROs with startup planning that treats activation as a controlled process with owners, critical path items, and weekly visibility, not a pile of emails hoping sites respond. Activation criteria are written so a site is either green-lit or not, with no informal middle ground that creates inspection risk.

Core activities include site identification criteria, feasibility questionnaires that ask useful questions, and green-light packages covering Form 1572 or equivalent, CVs, medical licenses, IRB or ethics approvals, clinical trial agreements, and budget finalization. We help teams track country-specific submissions, import licenses where needed, and pharmacy or depot readiness so IP arrives when the site can actually dose. Feasibility that only collects optimistic enrollment guesses is rewritten to test procedure capability, competing studies, and staffing reality.

For multi-country programs, we map parallel versus sequential startup paths and flag where local regulatory clocks will dominate. Essential document QC and eTMF filing during startup matter because incomplete site files early become inspection findings later. We also look at site training completion and system access for EDC, IRT, and ePRO before declaring a site activated. Kickoff meetings are used to confirm visit workflow and query expectations, not only to share slides.

When startup is already late, we run a recovery plan: rank sites by true readiness, clear contract blockers, and sequence ethics and IP release so the first sites can open without waiting for the entire country list. Transparent dashboards keep sponsor leadership and the CRO aligned on what is actually gating FPI.

Study startup and activation support commonly covers

• Feasibility design and site selection criteria
• Essential document collection and QC
• IRB ethics and regulatory submission tracking
• CTA budget and contract cycle management
• IP release and pharmacy readiness checks
• Site training and system access confirmation
• Activation dashboards and critical path reviews

If startup on your study is slipping or activation criteria are unclear across regions, we help rebuild a transparent activation process that gets qualified sites open without cutting corners on essential documents.