CCG Clinical Operations, LLC

Clinical Operational Consulting

ACRP-CP^® Certified Clinical Research Professional with 10+ years in GxP delivering high-quality, remote clinical trial oversight for global CROs and Sponsors

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