Site Monitoring
Full-Scope Site Monitoring
On-site and risk-based monitoring across the study lifecycle.
Site monitoring is where protocol adherence, data quality, and patient safety meet on the ground. ACRO's clinical research associates conduct end-to-end monitoring — from site initiation through close-out — so sponsors can rely on consistent oversight across every visit.
Our CRAs work as a single team across both on-site and central monitoring, applying risk-based principles to focus effort where it most affects the trial's integrity.
Related reading
Why it matters
Monitoring quality determines whether a trial's data will withstand regulatory inspection, sponsor audit, and downstream analysis. ICH E6(R3) emphasizes a risk-based approach, where critical data and critical processes are prioritized over uniform 100% verification. Consistent CRA oversight — by the same team that knows the protocol — ensures issues are identified early and resolved before they affect the database.
What we offer
- Site initiation visits (SIV)
- Routine on-site monitoring visits
- Close-out visits (COV)
- Source data verification (SDV) and source data review (SDR)
- Investigational product (IP) accountability
- Protocol compliance and GCP oversight
- Risk-based monitoring (RBM) plan development
- Remote and centralized monitoring activities
- Investigator-initiated trial (IIT) and regenerative medicine trial monitoring
How we work
Monitoring activities are planned from the protocol stage, with critical data and processes identified before the first patient is enrolled. CRAs execute the monitoring plan through on-site visits and remote review, with regular reporting to sponsors. Risk indicators are tracked across sites so escalation happens early, not at database lock.
Related services
- Biostatistics — statistical methodology informs monitoring focus
- Protocol Development — protocol structure drives monitoring focus
- Site Feasibility & Selection — site selection informs monitoring planning