Device Sponsors
The Opportunity
Validating the safety and effectiveness of medical devices is a complex process, often involving many actors, which must be carefully documented and tracked. Any changes to device’s design or usage, including trial site user certification, must be carefully monitored. From a data collection and sample processing perspective, the device manufacturer must not only collect, store, de-identify, track and analyze patient samples, but the complete event history and sample handling process must be managed as well. Any type of deviation or exemption must be documented and explained. Together, these needs represent a real challenge to any device manufacturer.
Our Solutions
Fortunately, there is now a comprehensive clinical trial management system for addressing these needs. Clinical Conductor Enterprise provides the tools to handle the complete enterprise workflow for device manufacturers, from documenting of validation protocols, recruitment of independent research sites to perform the investigation, collection of data from the sites via an intuitive site portal, and information management and analysis tools for working with the sample data itself. Built-in inventory management and equipment management modules enable manufacturers to keep track of device versions, associated upgrades and software revisions, and to associate and track training and certification for site users. Built-in event tracking provides a complete audit trail of complaints, complaint resolution, calibrations, service and updates – all in a comprehensive and searchable database. Finally, all study related activities roll up into fully integrated financial tracking and reporting tools. The result of using Clinical Conductor Enterprise is improved financial performance, ready proof points, fewer trial delays, and streamlined communications.
Our Products
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