Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

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.

We live in a fast-paced world; a world where new technology and innovation develops in rapid succession.  We are always seeking the “latest and greatest” in technology.  Intertwined in this world of technology and innovation, lies the world of clinical research.  People who are ill or disease-ridden have faith and hope that a miracle cure or life saving device is just around the corner.  But what happens when society as a whole loses faith in clinical research?  Who will volunteer for research studies when trust in the system fails?

Being a CRO that specializes in helping companies gain FDA and world-wide approval through monitoring, auditing, training and consulting services- it’s fair to say we’ve come across a wide range of fellow CROs, investigative sites, research teams, and hospital systems. It’s amazing how much innovation exists- not just with the investigative products- but with technological advances to platforms used the healthcare industry.

Each sector of the research industry faces its own unique challenges. For instance, take clinical research involving drugs versus devices. While some aspects of the research process and clinical trial are the same, their differences require special attention to have a compliant and well-controlled study. Likewise, an article titled, “Combating the challenges of medical device development,” investigates how medical device development is similar to other product development- but still faces unique challenges.

A new report was published by the Institute of Medicine (IOM), which outlines ten recommendations to achieve a better health care system. The report, “Best Care at Lower Cost- The Path to Continuously Learning Health Care in America,” touched on elements that directly influence our industry. The ten recommendations fell into three main categories:

As those of us who work in clinical research know, there’s always another study that needs volunteers and never enough volunteers for that study.  If you’re wanting to volunteer for a study, you can always check out ClinicalTrials.gov for information about current studies worldwide.  This site is a registry and results database for federally and privately supported clinical trials.  This site, developed by the National Institutes of Health, was designed to provide valid and correct information about clinical studies.

Whether on the site or sponsor level, in clinical research we are asked to use Good Documentation Practices (GDP) during the conduct of a clinical trial.  One might assume that a quick visit to the FDA website would produce the list of practices.  However, there is no Code of Federal Regulations for GDP.

I came across a recently published article, “Clinical Trials Have Gone Global: Is This a Good Thing?” published by Lang and Siribaddana. The title immediately caught my attention and begs the question: why is there a trend of clinical trials going over seas, and what are the possible consequences? The paper is divided sub-headings that pose the following enquiries:

Everyone has a “To-Do” List or lists; Things to do at work, at home, during the week, on the weekends, sometimes even on vacations.  To-do lists pile up and add up.  Just when you think that your list may be shortening, more to-do’s get added on or new lists are started.