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Rave Targeted SDV fact sheet
IDC Health Insights Partial Source Data Verification: The 95% Solution at 50% of the Cost Bio-IT World podcasts: Evaluating a Risk-based Approach to Good Clinical Practice The Impact of Technology on Clinical Monitoring VIEW on Clinical Operations: Clinical Monitoring: How EDC Has Changed the Game |
Targeted SDV Key Features |
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- Build and execute a risk-based, partial SDV plan based on study parameters (e.g., phase, size, complexity) and site experience
- Assign enrolled subjects to pre-configured SDV regimens using a robust statistical algorithm
- Exclude subjects based on their status (e.g., screening failure, early termination)
- Modify SDV plans during the course of a study
- Manually override SDV plans at the subject level
- Gain real-time visibility into SDV progress
- Fully audit subject SDV activities
Contact Us |
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| +1 877 511 4200 info@mdsol.com |
Capturing Data | Managing Data | Reporting Data | Building Studies | Site Monitoring | Safety
Rave Targeted SDV provides research sponsors and CROs with an EDC-based, scalable and auditable solution to execute partial (less than 100%) SDV strategies and enables compliance with their regulatory framework. It empowers researchers to implement a risk-based site monitoring approach that can potentially improve monitoring efficiencies without compromising data integrity. Targeted SDV allows you to:
Clinical Site Monitoring
Improving the efficiency and effectiveness of clinical monitors is key to managing study budgets—site monitoring activities represent one of the largest cost drivers in clinical research today. The Medidata Rave® EDC/CDM platform has greatly enhanced monitors' ability to work with sites to ensure that clean data is available quickly, by providing tools to:- Automate edit checking
- Remotely query sites' data entries
- Accelerate source document verification
Rave Targeted SDV—Unlock the Potential of Risk-Based SDV Strategies
Rave Targeted SDV provides research sponsors and CROs with an EDC-based, scalable and auditable solution to execute partial (less than 100%) SDV strategies and enables compliance with their regulatory framework. It empowers researchers to implement a risk-based site monitoring approach that can potentially improve monitoring efficiencies without compromising data integrity. Targeted SDV allows you to:
- Reduce SDV efficiently with an EDC-based solution
- Flexibly configure SDV plans to meet your objectives
- Apply robust controls to implement your regulatory strategy
- Minimize changes to existing SDV processes in executing partial SDV
Rave Monitor—Manage Site Visit Reports from Within Your EDC System
Medidata Rave extends site monitoring capabilities to improve a key aspect of the monitor's role—reporting on site visits—implemented within the software they use every day. Rave Monitor is a visit reporting tool for sponsors and CROs who need a more scalable, efficient and compliant way to manage site visits. It provides monitors and study managers with visit report capture, approval workflow and intra-/inter-study status reporting—and does so within the context of your Rave study. With Rave Monitor you can:- Complete site visit reports anywhere, e.g., online and offline
- Reduce report approval cycle time
- Gain visibility into key operational metrics
- Use the same familiar, intuitive Rave interface