Services
Services are delivered as sponsor-side embedded leadership, designed to integrate with sponsor and CRO teams. Each service line is defined by boundaries, deliverables, interfaces, and response expectations.
Service lines
Embedded sponsor-side operational leadership to drive oversight, decision traceability, and execution discipline alongside CRO and vendor teams.
- Governance plan
- Risk register
- Issue log
- Weekly status report
- Vendor oversight agenda
- Decision log
Response expectations are defined at project initiation, aligned to protocol risk and enrollment pace.
Sponsor clinical operations, CRO study team, vendors, functional leads.
Does not replace sponsor-of-record responsibilities and does not act as a full CRO.
Structured medical review and safety governance, including escalation pathways, cadence, and traceable outcomes.
- SAE review process
- Medical escalation workflow
- Safety review cadence
- Medical monitoring plan input
- Query guidance
Standard targets often include 24 to 48 hour medical escalation response where applicable. Final SLAs are contractual.
Sponsor medical lead, PV, CRO medical monitor, safety vendor, sites through defined pathways.
Not a 24/7 call center unless contracted and documented.
Support vendor performance tracking, escalation discipline, and documented governance.
- Vendor performance dashboard input
- Escalation notes
- CAPA tracking
- Oversight meeting minutes
Escalations are time stamped and closed with documented outcomes.
Sponsor vendor management, CRO PM, quality, functional vendors.
Does not contract as the prime CRO unless explicitly engaged under separate terms.
Readiness support designed to keep oversight, documentation, and processes inspection ready throughout execution.
- Readiness checklist
- Mock inspection support
- TMF health review summary
- Corrective action tracking
Cadence and scope are aligned to study phase, geography, and inspection risk profile.
Sponsor QA, CRO TMF, clinical ops, functional owners.
Controlled documents are provided during qualification, not published publicly.
Operational enablement for expansion, with partner alignment, feasibility, and continuity planning for time zone coverage.
- Country startup guidance
- Partner onboarding
- Operational feasibility
- Time zone and coverage planning
Response commitments defined per engagement.
Sponsor operations, CRO, local partners as applicable.
Sponsors and CROs retain regulatory responsibilities as defined by contract.