ClinDatrix guarantees the delivery of high-quality CRO services through comprehensive clinical project management and rigorous monitoring, tracking, and reporting systems. Each project is led by an experienced project manager, ensuring a streamlined process from start to finish.
Clinical Trial Monitoring
ClinDatrix Clinical Research Associates (CRAs) ensure rigorous oversight of patient eligibility, protocol compliance, data integrity, and regulatory documentation from site qualification to study closeout. This process is supported by a set of clinical performance metrics, which safeguard the quality and reliability of each study.
- Site Qualification:
- Successful site selection is critical. ClinDatrix evaluates site capacity, interviews clinical staff, and inspects equipment. Each site qualification visit is planned, conducted, and reported to ensure the best fit for investigator recruitment.
- Site Initiation Visits:
- Our CRAs provide comprehensive training on the study protocol and investigational brochure to investigators and clinical site staff. They provide detailed guidance on CRF/eCRF completion, regulatory document review, and patient enrollment strategies, as well as instructions for safety reporting, query handling, and drug/device management.
- Interim Clinical Trial Monitoring:
- Throughout the study, ClinDatrix’s CRAs perform ongoing site monitoring to ensure compliance. This includes:
- Development of a Clinical Monitoring Plan. The Clinical Monitoring Plan identifies all critical variables that must be monitored 100%. Risk-based monitoring may or may not be incorporated into this plan, depending on the protocol, study requirements, and sponsor preferences.
- Verification of informed consent and HIPAA compliance.
- Monitoring for protocol violations/deviations.
- Source and CRF/eCRF data review.
- Adverse event reporting and query resolution.
- Regulatory document review.
- Drug/device accountability.
- Throughout the study, ClinDatrix’s CRAs perform ongoing site monitoring to ensure compliance. This includes:
- Closeout Visits:
- As studies conclude, ClinDatrix finalizes all required documentation to prepare for potential audits (e.g., FDA audits). Key activities include:
- Final review of source documentation and CRF/eCRF data.
- Reconciliation of regulatory documents.
- Completion of adverse event documentation and query resolution.
- Study drug/device accountability (including return or destruction).
- Detailed review of the site’s post-study obligations.
- As studies conclude, ClinDatrix finalizes all required documentation to prepare for potential audits (e.g., FDA audits). Key activities include:
Contact ClinDatrix today to learn more about how our clinical trial monitoring services can elevate your research projects.