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)
