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, GCPs, ICH guidelines and FDA regulations.
Our team of regionally based monitors includes highly qualified professionals with an average of five 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
- Site monitoring — pre-study, site initiation, interim, and close-out visits
- Verify eligibility of subjects
- Conduct 100% source document verification
- 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