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

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