Risk Monitoring Platform
To help reduce the cost of site monitoring / clinical trials, FDA / EMA has recommended Risk Based Monitoring approach as an alternative to 100 % on-site source data verification. The essense of the approach is to remotely monitor meaningful site and data metrics rather than every piece of data on a continium. Clindata Cloud uses cutting edge technology to mine data and monitor risk proactievely to ensure subject saftey and trial integrity.
Data Quality
Completeness
Integrity & Consistency
Outliers & Errors
Data Trends
Unusual data distributions
Fraud and data fabrication
Severe Adverse Events
Centralized Monitoring
CRO Oversight
Screen failure rate
Patient withdrawal rate
Patient treatment adherence
High frequency of eligibility violations
Delays in reporting data
Regulatory Non- noncompliance Incidents
Severe Adverse Events & Deaths
FDA 21 CFR Part 11
FDA 21 CFR Part 312
HIPAA
GCDMP
GxP
CDISC
IRB compliance
Investigator conduct
Regulatory Compliance
Machine Learning & Pattern Recognition Algorithms
Predictive Big Data Analytics
24 x 7 Monitoring & Alerts