CRO Oversight & Monitoring Support

Ensure trial integrity and compliance with our specialized CRO oversight and monitoring services, fully aligned with ICH E6(R3) GCP for clinical studies and OECD GLP for preclinical/veterinary work. We provide proactive risk-based monitoring, site management, and multisite selection to deliver high-quality data on time and within budget.

Risk-based monitoring (RBM) includes on-site and centralized oversight of protocol adherence, source data verification (SDV), SAE reporting, and informed consent processes. We conduct routine, triggered, and close-out visits, generating comprehensive monitoring reports with CAPA plans to support FDA/EMA inspections and audit readiness.

Veterinary and non-clinical oversight verifies GLP compliance through facility audits, raw data review, SOP adherence, and QA statement validation. Services cover animal welfare (AAALAC), dose formulation analysis, bioanalytical method validation, and study reconstruction for IND-enabling toxicology/PK studies.

Strategic site selection via feasibility surveys, investigator CVs, patient recruitment modeling, and diversity assessments for global/multisite trials. We manage activation timelines, train site staff, and centralize IMP management/distribution while tracking enrollment forecasts and retention strategies.

Integrated dashboards for real-time metrics (enrollment, queries, deviations)

Vendor qualification and performance scorecards

Regulatory intelligence for CDSCO, MHRA, and ANVISA-aligned execution

Final oversight reports for CTA/IND dossiers and BIMO inspections