RISK-BASED STUDY EXECUTION

FOCUSING ON WHAT REALLY MATTERS, BY DESIGN.

Our risk-based study conduct services provide a better way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety, data quality and delay the approval of Investigational Products. Underpinned by Central Statistical Monitoring, a technique that’s currently being utilized by the Food and Drug Administration (FDA) for selecting sites for inspection, our solution can lead to up to 40% reduction on site monitoring vists and SDV, while flagging risks much earlier on.

Designed to be swiftly integrated to any site monitoring models, our risk-based study conduct services will help you optimizing your CRA workforce, while flagging and tracking risks near real-time. Early detection – Early action – Early success.

Forget about huge monitoring costs and compromised study data due to quality issues. Our data analysts, supported by high-tech smart engines, will be the eyes behind you studies’ conduct to make every data point counts, so that your product can reach the market faster.

SITES AT RISK

 
The Key Risk Indicators (KRIs) Dashboard harnesses the power of statistical algorithms providing a convenient way to monitor how sites are performing versus the metrics that are important to the trial. Sites are ranked and prioritized by those with most performance issues, thus illuminating the sites that are ‘at risk’.
Risk Based Clinical Trial Clinergy Health
Risk-based_Clinical_Trial_Clinergy_Health

KEY METRICS

 
The Quality Tolerance Limits (QTLs) module allows for rapid identification of systematic issues, documentation of quality management approaches and any deviations from the pre-defined limits, supporting compliance with ICH E6 (R2).

ATYPICAL PATIENTS

 
Coupling Patient Profiles with Central Statistical Monitoring offers a more targeted approach for clinical teams to prioritize the investigation of atypical patients, by identifying anomalies in data and ranking patients by their relative degree of atypicality.
Risk-based_Clinical_TRials_Clienrgy_Health

Let's advance science together.