NCGS, Incorporated is a full-service international CRO managing clinical trials since 1984 in drug, biologic, device, diagnostics and consumer products. NCGS provides full-service or strategic sourcing needs focused on risk mitigation. Contingency planning is actively employed, not just planned for. NCGS is a WBENC certified diversity supplier. NCGS has supported the development or expanded labeling of 78 approved products and has ZERO 483s. NCGS clinical teams are first in class, highly- tenured professionals - 10+ years’ experience; A team remains throughout the trial - Turnover rates are discernibly different at less than 3% annually CLINICAL TRIAL THERAPEUTIC FOCUS INCLUDES: - Neuro-Psych (CNS) - Infectious Diseases / Critical Care - Oncology, hematology, transplant - Trials in multiple other areas have been conducted ROBUST DIVISION OF COMPLIANCE & RECRUITMENT SPECIALIST - CAPA initiatives - Due diligence auditing - eTMF - Subject recruitment - Call Center 24/7 - Trial Rescue - Safety, SAE narratives and SAE reconciliation FULL SERVICES INCLUDE: • Clinical Operations and Monitoring • Fully Integrated e-Based iCloud Systems - e-REMOTE: Risk-based monitoring - eTMF: TMF Migration, Consolidation - ePAY: Grants, Contracts, Payments - eDM: EDC, IWRS - ePRO:Patient Reported Outcomes - eCLIN: CTMS • Medical Monitoring & Clinical Safety • Quality Assurance & Regulatory Compliance • Global Strategic Sourcing • Medical Writing • Biostatistics