Full-Service CRO

Sponsors often need CRO capacity without losing sight of protocol ownership and regulatory accountability. Viltis helps organizations select, onboard, and oversee full-service CRO partners for pharmaceutical, biologic, and device studies. We treat CRO engagement as a controlled vendor relationship: clear scope, measurable deliverables, and documented oversight that holds up when an inspector asks who watched the watcher. The quality agreement and oversight plan are working documents, not shelfware signed at kickoff and ignored.

Selection work typically covers RFP design, bid defense review, and comparison of therapeutic experience, geographic footprint, and functional depth in monitoring, data management, biostatistics, and medical writing. After award, we help set governance cadence, escalation paths, and key performance indicators tied to enrollment, query aging, protocol deviations, and TMF filing lag. The point is early visibility into drift, not a stack of unused dashboards. We also look at how change orders will be controlled so scope creep does not quietly rewrite the study budget and timeline.

When a CRO relationship is already under stress, we support remediation: gap assessments against the contract and quality agreement, CAPA focus on root causes, and interim sponsor oversight where functional coverage is thin. We do not replace your CRO; we help you manage it with enough rigor that study integrity stays defensible. That can include sample review of monitoring visit reports, co-monitoring, or targeted TMF audits before an inspection window.

Transition planning matters when you dual-source functions or change CROs mid-study. We help map data, TMF, and site communication handoffs so investigators are not left guessing which portal or contact is current. Clear sponsor decision rights during transition reduce enrollment pauses and documentation gaps. A short period of dual access with a written cutover date usually beats an abrupt switch that freezes site activity.

Full-service CRO oversight commonly includes

• RFP and bid defense facilitation
• Quality agreement and oversight plan drafting
• Kickoff and governance meeting structure
• Enrollment and site performance review cycles
• TMF and monitoring quality sample reviews
• Issue escalation and CAPA tracking with the CRO
• Transition planning for CRO change or dual vendors

If you are choosing a full-service CRO or correcting an oversight model that is not catching problems early enough, we can help you set practical controls matched to study risk and phase.