CLINICAL

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Simplifying the medical device design and development pathway while planning for contingencies requires design expertise and experience. Based on the indications for use and the claims we can support an accelerated development program that mitigates the risks, time and costs.

We have the expertise, experience, and infrastructure to help you navigate the complex regulatory and clinical development issues to accelerate your product to commercialization.

Clinical Study Planning and Design

Transforming a new medical device technology into a commercial reality is a complex, expensive, and time-sensitive process. We help you navigate the clinical development requirements and structure a cost effective solution through our fully integrated medical device CRO.

Clinical Services

  • Clinical SmartStudy™ study protocols
  • Clinical study management
  • Site and patient feasibility assessments
  • Human factors study design
  • Bridging studies to support reference and historical data
  • Patient mapping
  • Patient recruitment and engagement
  • Patient advocacy
  • Scientific and medical advisory boards
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image of test tubes
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