We connect our partners with the thriving Regenerative Medicine device industry to help support pre and post-market studies and trials.
There are hundreds of companies offering devices and products for the regenerative medicine market. Most of them do not have the financial or personnel resources to conduct lengthy, expensive clinical trials. Moreover, the U.S. F.D.A. and other regulatory agencies have recognized the value of more flexible approaches to clinical trials, so long as the resulting data meets statistically significant safety and efficacy end-points. (Aggregated data from multi-center trials is an important example of this flexible approach.)
With its inherent focus on cell/tissue characterization, data capture and reporting, collaboration on the same observation protocols with other RMCE’s around the world, and an independent respected C/SAB, an RMCE is an attractive platform for industry-sponsored studies, trials, wet-labs and educational events.