Risk-Based Quality Management
Our philosophy and study-specific Risk-Based Quality Management (RBQM) strategies align with regulatory and industry guidance including ICH E6 (R2) as well as that issued by the FDA, MHRA, and European Medicines Agency.
Central Risk Management
The protection of critical data quality and patient safety is the key to a successful trial. To give this activity the oversight it deserves and take ownership, we assign a Central Risk Manager for every full-service trial.
The Central Risk Manager is an expert in identifying, tracking and imitating risk in trials and leads your Integrated Data Review strategy to ensure that reduced source data verification is conducted according to what matters most.
Key benefits:
- Provides advanced risk visualizations, categorization, and awareness of trends over time through use of a relational database.
- Enables lower variability in risk oversight due to portfolio-dedicated resources.
- Keeps study teams on track for risk observations and mitigations.
- Evaluates how the mitigation worked and identifies where adjustment is needed.
Central Monitoring Management
Using statistics, we remove extraneous differences between sites and perform a holistic review for risk signals in integrated trial data. Our monthly review of 15 standard Key Risk Indicators identifies risk signals across sites and regions to inform appropriate levels of targeted source data verification.
When partnered with our risk management process, we move beyond data visualization to actionable insights that guide your decisions, every step of the way.
Key benefits:
- Allows for early detection of risk to critical data.
- Provides statistically significant differences in site performance.
- Allows for a reduction in source data verification (SDV) without a reduction in surveillance of data quality
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Across every stage of your clinical journey, we’re by your side to help you advance through clinical trials to get your therapy to patients and help bring your science to life.
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