Compliance In Focus

It has always been my goal to make clinical research education more widely available to professionals, raising standards across the industry. This vision was the foundation for IMARC more than 16 years ago, and now, we’re taking another major step toward realizing that vision. Starting today, clinical research professionals will have easier access to affordable training through IMARC University, our new series of online training courses.

IMARC Research’s whitepaper investigates the differences between the drug and medical device clinical research process.  First and foremost, there is a common thread that ties the seemingly different clinical research processes together…patients.  Real people exist on the other side of an investigational product and they face risk when they choose to take part in a clinical research study.  So while the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the game goal:  to safeguard those research participants while bringing safe and effective products to the market as quickly as possible.

For clinical research professionals, the protection of human subjects has always been of paramount importance.  Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team.  Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.

IMARC Research has launched a new YouTube Channel that presents our people and services in a video format.  YouTube is the second largest search engine in the world (just behind Google) and since over 85% of Americans watch videos on-line, we thought it was time to launch our own channel.

IMARC Research’s whitepaper investigates the differences between the drug and medical device clinical research process.  First and foremost, there is a common thread that ties the seemingly different clinical research processes together…patients.  Real people exist on the other side of an investigational product and they face risk when they choose to take part in a clinical research study.  So while the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the game goal:  to safeguard those research participants while bringing safe and effective products to the market as quickly as possible.

Clinical trials conducted in the Cardiovascular (CV) arena are challenging, first and foremost, due to the variety of underlying disease states and conditions that affect a majority of potential trial participants. In addition to participants coming into the study with multiple co-morbidities, CV studies themselves can be quite complex.

IMARC Research, a  CRO offering monitoring, auditing and training services  and ImageIQ, an imaging contract research organization (CRO) and, have announced a partnership that will strengthen the abilities of both organization’s clients to manage the complexities of imaging within clinical trials, and to enhance FDA approvals by ensuring that scientific data is optimized and that processes are compliant.  ImageIQ will provide IMARC clients with their imaging and image analysis clinical trial expertise.  Conversely, IMARC will bring its 14 years of clinical trial management experience to ImageIQ clients that utilize ImageIQ’s imaging analytics and software development expertise.

A project that has long been in the mind of Sandra Maddock’s has come to life.  The challenge was how to translate key events in clinical history into a series of images that depicted both the amazing and tragic events that have impacted medical research.

For all clinical trials, operating in compliance with the federal regulations, the agreements, the investigational plan, and the requirements of the IRB are critical to protect human subjects and to demonstrate quality and integrity of the resulting data. When imaging is introduced into a clinical research trial, a new layer of complexity is added, and additional considerations with regard to helping sites maintain compliance with the imaging requirements should be implemented.

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.