The main purpose of the EarlyBird® Platform is to guarantee critical process and data identification, early risk detection, evaluation, control, communication, review, reporting and providing a centralized location where risk data are saved, managed and monitored.
10+ years of research in data quality and statistical data mining allowed us to develop Cyntegrity’s EarlyBird® System. This is an advanced RBM Real-time Business Intelligence Analytics platform, which is dedicated to evaluating clinical data quality, performance and risks. Moreover, it offers a collaboration environment for efficient risk mitigation.
Cyntegrity’s RBM platform includes everything that one needs for a successful RBM process:
Statistical Data Monitoring
Risk Mitigation Process
What makes RBM System EarlyBird® unique?
An umbrella approach (all clinical recording systems are involved)
A willingness to share (network of partners and clients, active involvement of sites)
Driven by scientific innovation (e.g. in-depth validation of risk indicators for each trial)
Independence, therefore, absence of “conflict of interests”
Risk Profile of Clinical Sites. Based on accumulated parameters from previous clinical trials, EarlyBird® categorizes sites into low, medium and high risk sites.
Dynamics of Risks in Your Trial. How has a risk developed from last month? You can see the risk dynamics on EarlyBird® interactive charts and react quickly to approaching issues.
Improved Statistical Significance. Continuous data quality surveillance reduces “data noise” in a clinical trial, makes confidence intervals narrow and improves the chances to reach statistical significance.
Monitoring Cost Reduction. Tailoring monitoring to identified risks reduces the number of costly on-site monitoring visits in a long run. A structured monitoring approach allows a CRA to skip repetitive tasks, which increases efficiency.
Better Clinical Results. EarlyBird® equips you with corrective and preventive actions (CAPA principle). Your team has all the information to react to appearing issues. All activities are audited and tracked automatically – a great support during audits.