Complete life-cycle support

Complete life-cycle support

Full life-cycle support for design of medical devices and diagnostics

Many of our people come from sponsor companies, so they know what to ask up front. What indication provides the best return on investment? What claims make sense? How can you ensure that your device will qualify for separate reimbursement? What kind of pricing should you plan on?

There’s a lot to think about, and we focus all aspects of the development process with the single goal of turning your medical advance into a successful brand. Our full-service support for medical devices and diagnostics includes:

  • Strategic and tactical study design
  • Clinical trial setup and operation
  • Project management
  • Clinical monitoring
  • Study nurse and technical site support services
  • Medical affairs and strategic consulting
  • Interactive randomization technologies
  • Predictive, proactive risk prevention planning
  • Up-to-date intelligence on changing EU/FDA regulations
  • Data Safety Monitoring Board and Clinical Events committee services
  • Risk-based monitoring
  • Rapid identification and assessment of potential risks
  • Customized safety and vigilance management
  • Electronic data capture
  • Data management
  • Adaptive design
  • Biostatistics
  • Medical writing
  • Regulatory affairs and regulatory advisory services
  • FDA advisory panel preparation
  • Post-market health economics, pricing, and reimbursement strategies
  • Post-market surveillance and registry services
  • Global safety services
  • Technology that automates and simplifies the clinical development process and helps our customers, employees, and vendors focus more on innovation and less on administration

 

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