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Boston | Israel | Germany

Study Design Services

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