Medical Device CRO Blog

Gamification is defined as “the process of turning an activity or task into a game or something resembling a game.” This concept has been leveraged in the fields of education and marketing to create engagement with a topic or product by using game playing techniques such as point scoring, achievement badges, or virtual currency.

The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently  released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

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.

Please take time to review Emily Haglund’s article “Risk Management in Clinical Research Process and Application” that was recently posted on GxP Lifeline.  The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.

When the Food and Drug Administration (FDA) identifies significant findings with the conduct of a clinical trial during an inspection, what happens to those findings? According to a recent article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.

As monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself. Before your next monitoring visit, consider asking yourself these five questions:

There has been a recent trend in clinical research toward the use of central Institutional Review Boards (IRBs) or Ethics Committees (ECs) for multi-center trials. 21 CFR Part 56.114 outlines the following on cooperative research:

Since the suicide death of Dan Markingson in May of 2004, there has been a lot of debate as to whether or not the 26 year old psychiatric patient should have been approached to consent to participate in a clinical research trial for the comparison of three atypical antipsychotic drugs. Recently, there has been an article published in the Minnesota Daily about a petition signed by over 3,000 ethicists, researchers and scholars asking the University of Minnesota’s President to review the case to prevent future tragedies at the institution. Such a petition was created due to several errors in processes related to human subject protection.

The FDA’s device center (CDRH) has established time based performance standards to help ensure draft guidance documents do not remain in an unresolved state for too long.  The following draft performance goals have been outlined: