Understanding the challenges of IVD development in a world dominated by drug names
By Kathryn E. Vinson, MS, CCRC
Our world is moving at an amazing pace. Despite the SARS-COV-2 pandemic, and in some respects as a direct result of the same, our needs in the medical community for new devices and diagnostic equipment have been on a steady uptick. While the majority of news seems to go to new pharmaceutical options, diagnostic and device developments are just as important, and in some cases even more important than their medical counterparts. Some folks may question why that is. It’s pretty simple – if you can’t safely, quickly, and accurately diagnose conditions – you’re behind the metaphorical eight ball.
Bringing new diagnostic tools and medical devices to the market is not an easy task. The expertise required to develop new devices and diagnostic tools is extensive, with each category needing its own set of skills, similar to specialty disease areas in trials for investigational new drugs.
For those new to the IVD testing scene, there are many challenges that aren’t always present in standard drug trials. With diagnostic devices, it comes as no shock that massive amounts of data will be pouring into your system from seemingly interminable quality and data verification checks. Project managers, data managers, and monitors must be able to not only make sense of sometimes discordant data, but also need to be able to know which elements are needed for testing purposes and which can be safely excluded.
When your company is ready to enter testing for one of these new devices or diagnostic tools, you have to be certain that you go to a group with not only the knowledge of the industry, but also the necessary hands-on expertise to see your trials through to success. This is where DZS Clinical Services comes in. From the “world’s first fully automated and integrated testing platform for blood grouping and donor screening”, to devices that have made life both simpler and more livable for chronic disease patients, DZS has the background to lead your team through these hurdles.
Our team of seasoned clinical research professionals not only have decades of combined experience in device and diagnostic studies but is also prepared to help you navigate the waters of protocol development and regulatory submissions. Whether you are the device developer or are a testing site, our experienced team can help you understand these trials and the complex challenges that they present. From modifications to monitoring and data management plans to deciding if remote monitoring is right for your trial and a plethora of other unique situations, DZS has the right solution for you.
A full forty percent of our recent trial experiences have been in the device and diagnostic market. Our facilities and associates around the world can ensure that the testing completed on your device will be held to the highest of global standards. From hematology to oncology to pulmonology, you can be certain that partnering with DZS Clinical Services will be “Your Direct Line to Efficient & Economical Medical Device and Diagnostics Studies.”