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Clinical Research & Regulatory Support Service
As a full contract research organization (CRO), Toolbox provides the fastest path to FDA clearance for your IVD diagnostic device study. Our team has achieved multiple dual and straight 510(k) and CLIA Waiver submission clearances and we can do the same for your medical device.
Our experienced team can design, develop, and execute the right study that meets the needs of your IVD product. Our network consists of over 100 clinical sites ranging from point-of-care physician offices to moderately complex reference labs which allows us to turn-start studies quickly.
For more than two decades, Toolbox has developed relationships that aid in your IVD product development and engineering success and help push through FDA, CE marking and IRB approvals.
- Project management from conception to completion
- Study design and protocol writing
- Site and laboratory identification, qualification, seletion and management
- Electronic trial master file (eTMF) creation and management
- Electronic data capture (EDC) design and build
- Customized data dashboard with daily updates throughout the study
- Statistical planning, data management and analysis
- ISO 20916 compliance
- Regulatory strategy development
- Q-Sub submissions and meetings
- Regulatory agency liaison
- Dual510(k) and CLIA Waiver, 510(k), De Novo and EUA submissions