Working With An IRT Partner
What is the difference between a medical device trial and a drug trial?
On a very basic level, there are some obvious differences between drug trials and medical device trials. The terminology is different (IDE vs. INC), the protocol varies, and there are different regulatory implications to consider. An understanding of these differences is crucial, but insight and innovation to address them can take your trial to the next level.
When selecting partners for your medical device trial, it’s important to consider the value and benefits of working with an IRT specialist. Medical devices are often more expensive and customized in comparison to typical study drug. Coupled with differing regulatory oversight/standards, very detailed records on the history of the device (where it has shipped, if it was returned, etc.) is required. Cenduit works with sponsors to pre-determine acceptable system functionality which provides a level of structure for the sponsor and sites. In addition to transactional elements, Cenduit will customize your reporting tools to ensure the sponsor and sites are able to accurately track a device and provide consistent answers for reporting.
Is your IRT system nimble enough to handle the complexities of your medical device trial?
Medical device trials require that the IRT system you use is nimble to account for trial complexities and to respond to a fast-paced, ever-changing schedule. When dealing with study drug, sponsors are concerned about expiration of materials and accurately forecasting materials needs. Medical device trials add other layers of complexity including unpredictable patient enrollment, urgent/critical device implantation, and ad-hoc device changes due to size or inadvertent contamination to name a few. Your IRT system cannot hold up the care of a patient – you need a system that can efficiently serve the unique needs of device trials.
The high cost of medical devices means they will likely need to move around a lot. If the device is sized incorrectly or patients don’t qualify, the device may need to go back to the depot for redistribution. Cenduit’s Drug Accountability Returns Management (DARM) allows you to keep a close watch on all devices and track their movement – saving time and money. At a standard level, the system allows sites to enter the device disposition, indicate the device being used, and account for immediate need for replacement (resizing, adjustment, or new device).
Finally, your IRT system needs to work in a smart and dynamic way from the release and distribution of the medical device. Due to their expense and frequently limited supply, medical devices often require just in time labelling, meaning your IRT must be designed as a cost conscious system that drives your supply chain to respond to distribution demands quickly and effectively. Cenduit’s supply chain expertise provides you both the consultation and system you need to ensure these unique needs are met.
Cenduit has extensive experience in the medical device trial realm. We have worked on studies ranging in size from 60 sites to over 1,000 sites and have coordinated over 10,000 patients across the globe. Each of our solutions is customized to your trial needs and takes into consideration the important nuances of medical device trials.