Core Services
- Consulting
- Provide expert guidance to support study operations, documentation quality, and team decision‑making
- Advise on risk mitigation, inspection readiness, and operational best practices for Sponsors/CROs
- End-to-End Study Management
- SSU, LPI to LPO, closeout
- Support study timelines, deliverables, and cross‑functional coordination
- Oversee startup, enrollment, and closeout to ensure operational compliance
- Remote and Onsite Monitoring
- Targeted Source Data Verification (SDV) and SDR to ensure data integrity and subject safety
- Train, assess, and support site teams to maintain protocol compliance
- Protocol Deviation and CAPA Management
- Perform root‑cause analysis and develop defensible CAPA plans
- Track CAPA implementation and verify evidence of completion
- Budget and Financial Oversight
- Over ten $2M – $9M projects managed
- Manage study budgets, forecasting, and burn‑rate analysis
- Reconcile vendor invoices and site payments against contracted deliverables
- Risk Mitigation Strategy & Issue Management
- Identify operational risks using RACT/KRIs and escalate emerging issues
- Implement targeted mitigation plans and document outcomes
- Vendor Oversight
- Evaluate vendor deliverables for quality, timeliness, and compliance
- Lead governance meetings and resolve performance issues
- TMF Quality Review
- Maintain TMF quality and ALCOA+ compliance across study phases
- Regulatory Compliance
- Ensure essential documents and submissions meet regulatory requirements
CCG Clinical Operations, LLC 