Site Monitoring
Our dedicated CRA team provides site monitoring from initiation to close-out, applying risk-based principles aligned with ICH E6(R3).
Site Monitoring Across the Full Trial Lifecycle
On-site and risk-based monitoring throughout the trial.
Site monitoring brings protocol compliance, data quality, and patient safety together in practice. ACRO's CRAs monitor the entire process from initiation to close-out, providing sponsors with consistent oversight at every visit.
Our CRAs deliver on-site and centralized monitoring as one team, applying risk-based principles to focus effort where it matters most for trial reliability.
Why it matters
Monitoring quality determines whether trial data can withstand regulatory inspections, sponsor audits, and subsequent analysis. ICH E6(R3) emphasizes a risk-based approach that prioritizes critical data and processes. Consistent oversight by a team familiar with the protocol helps identify and resolve issues before they affect the database.
What we offer
- Site initiation visits (SIVs)
- Routine on-site monitoring visits
- Close-out visits (COVs)
- Source data verification (SDV) and source data review (SDR)
- Investigational product (IP) management
- Protocol compliance and GCP oversight
- Risk-based monitoring (RBM) planning
- Remote and centralized monitoring
- Monitoring for investigator-initiated trials (IITs) and regenerative medicine trials
How we work
Monitoring is planned at the protocol stage. Critical data and processes are identified before the first participant is enrolled. CRAs implement the plan through site visits and remote review, reporting regularly to sponsors. Risk signals are tracked across sites so action can be taken before database lock.
Related services
- Biostatistics — Statistical methodology informs the monitoring focus.
- Protocol Development — Protocol structure shapes the monitoring focus.
- Site Feasibility & Selection — Site selection informs monitoring plans.