ClinOps VPs, study managers, CRA managers, and C-level executives all use ClinOps Insights to monitor study status and take action to avoid milestone delays.
- Keep all your data clean and up to date, for optimal portfolio oversight
- Quickly identify and address issues as they arise, from enrollment and compliance to site productivity
- Drill down to root cause, to address issues and answer queries more effectively
CRO Oversight & Collaboration
Sponsor study managers and vendor managers use this ClinOps Insights add-on to maximize CRO relationships and gain fast access to data that’s too often hidden from view. Real-time dashboards make it easy to track the performance of each CRO, study, site, and KPI.
- Monitor CRO quality agreements and oversight plans in real time
- Automate KPIs and thresholds to ensure compliance with ICH E6(R2) and other regulations
- Resolve issues quickly with collaborative task management tools
For sponsors and CROs alike, Comprehend’s Centralized Monitoring solution can be the cornerstone of an effective risk-based management strategy. Go beyond traditional site monitoring to significantly lower the cost, time, and risk associated with your clinical trial portfolio.
- Allocate resources more effectively, using cross-study and cross-site KRIs, root-cause analysis, and configurable tools that adapt to evolving needs
- Use automated alerts to reduce compliance risk
- Reduce regulatory risk with fully auditable collaborative task management workflows
Medical Insights is the first application to bring all your safety and subject-level data into a unified structure, for consistent and proactive medical review and safety signal analysis. Chief medical officers, medical directors, data management professionals, and other stakeholders all use the innovative capabilities of Medical Insights to enhance the medical review process.
- Use dynamic line listings and graphical patient profiles to highlight data changes
- Address protocol deviations and adverse events earlier, to reduce risk and support patient safety
- Use detailed labs, with access to actual test results, to visualize trends and identify outliers
Data management directors, medical directors, C-level executives, and quality control and compliance professionals benefit from KPI Studio’s ability to generate real-time dashboards based on the data points most relevant to each audience.
- Use data from all your systems—EDC, ePRO, CTMS, IxRS, etc.—to create custom KPIs and analytics
- Build meaningful tabular and visual reports
- Enjoy better quality and ease of use through built-in syntax validation, advanced calculations, and formatting
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