Monitoring

Accuracy ensured

Let us assist you in ensuring the integrity of your data. Research Assist’s regional monitors can ensure that your data are complete and accurate, and verify that it is collected and documented per the protocol, good clinical practices (GCPs), ICH guidelines, and FDA regulations.

Our team of regionally based monitors includes highly qualified professionals with an average of 5 years of industry research experience and a strong science or medical background. With these credentials, projects are managed more efficiently, there is less querying of data, and potential setbacks are anticipated and corrected before they occur.

services include

Site monitoring – pre-study, site initiation, interim, and close-out visits
Verify eligibility of subjects
Conduct 100% source document verification (SDV)
Assess integrity of data
Monitor for adherence to protocol
Ensure SAEs are reported and properly documented
Review CRF and EDC data
Review regulatory documents and reconcile with sponsor file
Perform drug accountability and reconciliation
Review subject recruitment strategies and retention techniques