Prevail has had significant experience in Medical Tech having worked on products that received FDA approval in the Medical Device space and worked on many other medical device or diagnostic products throughout the years. It knows the clinical nuances and the shifting regulatory requirements as the FDA and the CDRH tries to keep up with the innovation in this space. Prevail has developed specific analytics and tools for this market and has the software engineers and clinical experts to address any new requirements that develop.
While Prevail typically works with Class II or Class III products targeting a PMA approval and requiring pivotal IDE studies in the medical device or diagnostic areas, it can also scale down its technologies to also be useful for pilot studies and products going for a 510(k) or de novo 510(k) approval as well. Particularly on diagnostics, we typically work with IVD diagnostics and have also worked with pharmacogenomics diagnostics but have the flexibility to deal with any project or program requiring collection, integration, reconciliation and/or analytics of data across a large body of data.
Having a system that display averages, medians, quartiles and box-plots will create new insights. In combination with on-tap scatter plots, you can pick up on hidden trends and correlations that might have stayed obscured otherwise.
When you open a window into your study to potential acquirers, you might be surprised how helpful they can be – the questions they ask (and sometimes the suggestions they make) can add value to your study before it’s too late to make mid-course corrections.
Save costs across several studies and prevent expensive reconciliation of multiple databases by having a safety database that covers an entire product or program.
Keep track of all device inventory levels, be they at the site, depot or distribution center or elsewhere. Track shipments via all major carriers to ensure timely delivery. Manage this supply chain thanks to integrations, barcode scanning and custom phone or web interfaces – whatever it takes to get the job done.
Want to compare two fields quickly? Just select from drop-downs and run scatterplots at will, without programming or configuration necessary. Save, share and export information yourself instead of waiting days or weeks for a vendor to respond.
Graphs, scatter-plots and bar-charts are only useful if you can turn that realization into action. With Prevail, clicking or hovering-over a point, line or bar will take you to the data you need to enact change.
Take a look at some case studies or speak with a data scientist to see if real-time data is right for your project.