Carrying out a medical device or diagnostics clinical trial is a quite different process than conducting a medicinal one. The reason that some of these trials fail to meet their endpoints or critical milestones usually relies on their design that has been based on pharma industry standards.
At CORONIS we understand that apart from conducting a device trial in compliance with the medical device specific processes and regulations, we must think and act differently so as to make your initiative an actual commercially worthy plan.
Having run successfully more than 30 medical device trials over the last 10 years, we have identified the key parameters that guarantee your trial’s success.
We understand, that the accelerated technology improvement rate leaves no room for time delays, especially if you are developing an innovative treatment. Time may have at least double impact on medical device trials than has on medicinal product studies. Keeping this in mind, we have developed specialized management systems that allow us to complete projects in the minimum required time.
We understand, that an inadequate compliance related to their use may have a serious impact on study’s general outcome. This is the reason we pay so much attention on the selection of the investigational sites, taking always into account their on-the-field experience and the device type. Most important is the fact that our clinical team conducts twice-more-regular Investigator trainings to ensure their compliance with the IFU and -in this way- contribute in study’s clinical excellence.
By making special focus on devices and diagnostics, we aim on designing and conducting trials that will address our client’s objectives -from first-in-man through post-market studies- whether the intent is to obtain marketing authorization, improve reimbursement price or generate publications.