Pilot Studies

Innovative device designs require frequently a pilot clinical investigation or also called early feasibility study. This is a crucial step in product validation that should be carefully planned so as to get the right information out of it beyond just looking at whether the device works! MD-CLINICALS’ experts have a long track record of developing this pilot phase strategy so that it delivers the right information to build upon for full product validation up to successful market access.

  • Defining and finetuning claims
  • Get the most out of existing data
  • Develop well defined protocol summaries for early review with regulators
  • Prepare and conduct pre-submission meetings with FDA
  • Prepare and conduct pre-review meetings with Notified Bodies
  • Write successful clinical protocols and other study documents for fast track acceptance by ethics committees and regulatory authorities
  • Setup ‘early adopters’ clinical investigation sites
  • Fast reaction on trouble shooting during early phase use of the device
  • Ensure timely completion to keep overall clinical development plan on track
  • Adopted tools to small early studies with a long term visibility (cost-effective and resource optimized)
Contact us for a free half-hour consultation