Clinical Trial Monitoring

Clinical trial monitoring is a component of Octalsoft CTMS (Clinical Trial Management System). Monitoring begins with appointment scheduling and follows the monitoring workflow through to the approval of the monitoring and trip report. Issue management is a feature of the system, allowing the Clinical Trial Associate (CRA) to enter and report on issues as related to specific clinical monitoring questions or general issues that need to be noted and resolved.  Open issues are automatically carried forward to the next monitoring visit and report, enabling the CRA to better plan the next site visit. Octalsoft’s clinical trial solution manages study monitoring to ensure clinical site compliance with International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), and Health Insurance Portability and Accountability Act (HIPAA) regulations.