Clinical Data Repository - Features and Benefits
Using a proven methodology, our expert team works with you to develop and implement a customized Clinical Data Repository solution specific to your needs.
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Customized Reporting and Analysis: Using JReview™ - a web-based reporting and analytics tool.
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JReview allows you to not just report on your data, but to truly interact with it. You have the ability to graph, report and drill down in order to analyze your clinical data at multiple levels within a trial or across multiple trials. In addition, you are able to perform comprehensive safety analysis and trending enabling you to make critical, timely business decisions.
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Standardization: Using CDISC-compliant data models, your legacy and active trial data from various systems and sources are standardized and stored. A proven mapping process, compliant with FDA requirements, is utilized to integrate data into this centralized, 21 CFR part 11 compliant solution.
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This allows you to support data controls to safeguard “blinded” data and provide audit trails for traceability.
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Scalability: We partner with you to create a customized data collection, storage and access solution supporting your current needs and scale appropriately with the long term goals of your organization.
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By leveraging best-of-breed technologies, we integrate the data from your ongoing trials and map legacy data as needed.
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Additional Benefits:
- Ability to pool data across phases
- Review safety data across products
- Analyze data trends using a review tool across pooled data
- Use data mining for targeted populations
- Allow project teams to oversee and manage clinical trials through a single user interface with role-based access
- Get rapid, near real-time access to data on clinicians' desktops
- Respond to regulatory authority questions quickly and confidently
- Use data to make go/no-go decisions in product development
- Look for data trends on marketed products for best practices in patient care
- Provide access to investors and clinical development partners to make business decisions