Former FDA Commissioner Margaret Hamburg says FDA is still honing its medical device regulatory process so it strikes a balance between patient safety and industry’s desire to market their products. Speaking at the National Press Club in Washington D.C., which might be her last public appearance as commissioner. She indicated that she is not sure the U.S. or Europe have gotten the balance right yet.Read More
Medical Device CRO Blog
Recent widespread recalls of investigational products have led to harsher scrutiny and stricter rules from the Food and Drug Administration (FDA). Steps take to prepare for trials in the past are no longer enough. The path to FDA approval requires tremendous organizational skills and attention to detail to navigate; but with the right preparation and commitment to compliance, all of these challenges can be overcome.Read More
In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.Read More
Recently, the FDA issued a final guidance document regarding medical device data systems, medical image storage devices, and medical image communications devices. The FDA also held a webinar in February 2015 to support this guidance document.Read More
It’s without question that medical devices are becoming more and more advanced. These technological increases only continue to provide data, and lots of it! An article which asks, “Is The Medical Device Industry Ready for Big Data”- caught our attention and we’d like to know your thoughts, are medical device companies ready for what could be ahead?Read More
AdvaMed, the medical device trade group has never been shy about sharing its opinion with the FDA. According to a recent article in Medical Device and Diagnostic Industry (MD+DI), AdvaMed has voiced its opinions on what priorities the medtech industry believes the FDA should prioritize.Read More
In a report from the Institute of Medicine (IOM) was based on a workshop held with this focus: “Public Engagement and Clinical Trials.” In this report, IOM draws attention to the fact that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal.Read More
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 2015 calendar year.Read More
During a training module this week, a group of monitors were discussing the importance of back-up coverage. Monitors that are conducting visits in the field know that juggling schedules can be very challenging. To provide thorough and consistent monitoring, experienced monitors are assigned to a clinical trial or a study team. Next, training is extended into the therapeutic area of research and sponsor specific trainings including SOPs and monitoring plans. But what about back-up coordinators- are they trained and ready?
We are excited to have recently launched IMARC University, our latest service offering designed to make clinical research education more widely available to the industry. IMARC University is a series of affordable online training and continuing education courses designed to prepare you and your team for clinical research compliance. These courses cover many aspects of the clinical research process, from FDA regulations and Good Clinical Practice standards to adverse event reporting and how to conduct monitoring activities. All courses can be taken at your own pace. We can even create and customize additional training to meet the needs of your team.