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Device companies conducting clinical trials in Europe are vulnerable to different regulations and standards of contracting with different medical centers and operators.

Fortuna Clinical will guide the sponsor through this process and will aim to secure speedy contracts between the sponsor and device investigators and operators.

Medical Center / Cath Lab / OR Capability Assessment

  • Experience with devices/cases
  • Capability of the same day procedure
  • Application of the adequate anticoagulation/medication protocol
  • Experience with clinical studies/support staff
  • Volume of procedures/surgeries and local standard of care
  • Assessment of referral patterns
  • Assessment of on-going competing clinical studies
  • Operator willingness to participate/approachability, “Feel Factor”

 

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