This post is sponsored by IMARC Research, Inc. Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.” Although the Medical Device Amendments were enacted on May 28, 1976, it still seems that after all these years there is confusion and misunderstanding regarding the […]
This post is sponsored by IMARC Research, Inc. As a medical device focused CRO, we are often asked the difference between the investigational drug and medical device clinical research process. We view this as a very legitimate question and have actually devoted a whitepaper to explain these differences. Even though the clinical research pathways for […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
This post is sponsored by IMARC Research Inc. To monitor is more than a title. It is a mindset. While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is a shared mindset. What is a shared mindset? It […]
This post is sponsored by IMARC Research, Inc. Our popular Top 10 list of FDA warning letter findings is back! To assemble the list, IMARC’s clinical monitoring team reviewed warning letters issued by investigators and sponsor-investigators last year through FDA’s Bioresearch Monitoring Inspection Program. This list of warning letter findings is not intended to point […]
The roles that documentation serves in clinical research are to communicate to other health care professionals and to demonstrate the competence with which we do our jobs, and for clinical research, that means being able to prove that subjects were protected throughout the entire clinical research process. As inferred in the terms "clinical research" there are documentation requirements pertinent to a subject’s "clinical" status and there are documentation requirements pertinent to the "research" itself, thus increasing the documentation efforts required exponentially. While many look at informed consent as the main way to document patient protection in clinical research, this is only the beginning of the story.