Successful closure pre-CE trial Sweden blood compound technology

A pre-CE mark study for a new high tech device in the blood bank industry was succesfully closed with promising results.

The study was single site with involvement of healthy blood donors and in vivo re-infusions.  Both Competent Authority as well as ethical committee submissions were required.  LyncoClinical supported this project starting with protocol development, CRF design, submissions, monitoring and data review.