Documents
Study Management Services
Operations and Logistics
Clinical trials of medical devices are complex, requiring in-depth understanding of medical technology, regulatory requirements and clinical site operations. Boston MedTech CRO supports and manages the myriad of logistical and operational details required to successfully execute a medical device clinical trial, including:
- Establish a system for device distribution, tracking and storage
- Support patient training of home-used devices
- Provide technical support to the clinical sites for study devices
- Manage randomization requirements for study device assignment (e.g. blinded-studies using sham devices)
- Ensuring sufficient and timely supply of study-specific disposable and consumable products
- Act as U.S. agent for off-shore companies needing to import their devices to the U.S. for clinical trials