We recognize that it might not be easy to quickly grasp the concept behind the FAIR Shake™ training program, so we have posted a video on our company website that we believe will give you a better understanding of the training program.  Sandra Maddock, CEO and President of IMARC, is featured in the video and walks you through the training methodology.

In August 2011, FDA released a draft guidance document recommending a Risk-Based approach to monitoring. Risk- Based Monitoring combines the vigilance and data surveillance (key features of Electronic Data Capture systems) with traditional on-site data verification targeting critical data points. Rather than a standardized monitoring plan, Risk-Based Monitoring aims to adapt the monitoring plan to the changing needs of the Study, Site and Investigational Product.

With all due respect to this iconic Hawaii5-0 quote, an interesting thing happened recently at work, IMARC’s CEO Sandra Maddock was taken away in handcuffs!  Check out IMARC's Facebook page for pictures of our jail-bird being “arrested”.  Not such an unusual story in todays post-ENRON world, but this “arrest warrant” involved raising “bail money” for the Muscular Dystrophy Association’s “2012 West Cleveland Executive MDA Lock-Up™”.   The Muscular Dystrophy Association (MDA), nationally headquartered in Tucson, AZ is the largest non-governmental sponsor of research investigating the causes of and effective treatment for neuromuscular diseases.

The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority.