Trial team 솔루션
CRO improves study monitoring oversight and TMF completeness with cubeCTMS
Monitoring efficiency
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Background
A CRO running global Phase II and Phase III studies needed a clearer way to coordinate monitoring visits, manage Monitoring Visit Reports (MVRs), and keep study documents inspection ready. The CRO’s clinical operations team had been relying on spreadsheets and emails so far, but it became too difficult to see what was due, what was late, and what had been filed.
The team’s monitoring process became harder to manage especially as studies expanded across countries and sites. Visit schedules lived in spreadsheets, MVRs were created in documents and shared by email, and filing to the Trial Master File (TMF) depended on manual steps. Leadership lacked a single view of visit status, overdue items, and action follow up.
They needed to address the following challenges quickly to keep their clinical operations on track:
Complex planning workflowsMultiple trackers increased the risk of missed or duplicated visits. |
Dynamic study designFrequent amendments and country differences made schedules and actions hard to align. |
By implementing cubeCTMS, the CRO aligned planning, reporting, and filing for monitoring in one reliable flow. Teams gained live visibility, reduced handoffs, and kept documentation current across countries and sites.
Background
A CRO running global Phase II and Phase III studies needed a clearer way to coordinate monitoring visits, manage Monitoring Visit Reports (MVRs), and keep study documents inspection ready. The CRO’s clinical operations team had been relying on spreadsheets and emails so far, but it became too difficult to see what was due, what was late, and what had been filed.
The team’s monitoring process became harder to manage especially as studies expanded across countries and sites. Visit schedules lived in spreadsheets, MVRs were created in documents and shared by email, and filing to the Trial Master File (TMF) depended on manual steps. Leadership lacked a single view of visit status, overdue items, and action follow up.
They needed to address the following challenges quickly to keep their clinical operations on track:
Complex planning workflowsMultiple trackers increased the risk of missed or duplicated visits. |
Dynamic study designFrequent amendments and country differences made schedules and actions hard to align. |
Slow handoffsMVR creation, review, and filing happened in different tools, increasing the risk of miscommunication and inconsistent follow up. |
The CRO selected was looking for a solution that could centralize visit planning, MVR authoring and approval, and enable document filing in one workspace without compromising oversight or quality.
Solution: cubeCTMS & cubeTMF
Although the CRO considered standalone tools to address specific aspects of their needs, they chose cubeCTMS for its ability to unify monitoring workflows. They particularly liked the solution’s live dashboards and standardized MVRs. Whilst considering cubeCTMS, they discovered the benefits of combining both CTMS and eTMF solutions under a unified platform, and decided to implement cubeTMF for direct filing of MVRs and other documents.
When asked about which functionalities bring the most benefits to their organization, our client listed the following areas of cubeCTMS and cubeTMF:
Live oversight and visit planning
Centralized calendars with scheduled, completed, and overdue visits visible by study, country, site, and CRA.
Configurable report templates for Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), Close-Out Visit (COV), and for-cause visits to keep setup consistent.
CRA assignment and capacity views to balance workload and avoid clashes.
Automated reminders and alerts for upcoming and late visits to encourage timely action.
MVR authoring and action management
In-system MVR generation from study templates with required sections and fields.
Role-based review and approval workflows allowing CRAs, PMs, quality, and medical reviewers to work in one environment.
Clear tracking of action items all the way to closure with corresponding owners, due dates, and status reflected on dashboards.
eTMF integration and filing
Approved MVRs and supporting documents mapped to the eTMF and filed to the correct sections.
Filing status displayed alongside visit status enabling teams to confirm execution and documentation together.
Time-stamped audit history across planning, reporting, actions, and filing to support inspections.
Results
By implementing cubeCTMS, the CRO aligned planning, reporting, and filing for monitoring in one reliable flow. Teams gained live visibility, reduced handoffs, and kept documentation current across countries and sites.
Clearer oversightPMs gained a centralized view of visit status, overdue items, open actions, and TMF completeness. |
Faster MVR turnaroundStandard templates and in-system approvals shortened creation, review, and follow up. |
Improved TMF timelinessDirect filing reduced delays and helped documents land in the correct TMF sections. |
Compliance and inspection support
The same configuration that improved day-to-day work also strengthened inspection readiness: role-based access for MVR approval with e-signatures, improved consistency through the use of templates, and a complete audit trail of scheduling, changes, approvals, and filing actions.
Conclusion
With cubeCTMS, the CRO brought monitoring activities into a single, predictable flow. Live dashboards guided weekly priorities, MVRs moved from ‘draft’ to ‘approved’ faster, and TMF completeness improved. The outcome was clearer oversight and a monitoring process that helped studies progress with confidence.
By implementing cubeCTMS, the CRO aligned planning, reporting, and filing for monitoring in one reliable flow. Teams gained live visibility, reduced handoffs, and kept documentation current across countries and sites.
주요 사례 연구
