Clinical trials are crucial for new product and device development and are required by the Food and Drug Administration (FDA) before approvals can be granted for their use in the general population. Overall success is dependent on sponsors to supply clinically valid protocols, active participation of engaged sites, and adequate numbers of potential subjects who fit the inclusion/exclusion criteria and are able to participate through the study’s conclusion, are mandatory for the overall success of any study and the ability to answer the defined research problem. But what if technology could assist with bringing a trial directly to the patient?
What critical elements would need to be covered by the technology to accomplish a virtual clinical trial? The solution requires the ability to manage consent and re-consent practices, management of ePRO, real time collection of clinical data, management of dosing administration and compliance of investigational product or devices and facilitate ongoing study communication and documentation.
ClinOne’s platform includes managing all of these critical elements, allowing patients to manage the majority of their trial experience from the comfort of their own homes. Reducing physical site visits means saving millions of dollars on investigational site budgets. It also means that patients’ compliance rates and reduction of burden are completely transformed – the trial comes to the patients at a fraction of the cost of a traditional study. Sponsors are connected and engaged with their patients versus the significant separation between the two under the current model.
“The significant variance on site quality can be eliminated. The dependency on coordinators can be eliminated, and the level of care can be profoundly improved for patients,” according to Rob Bohacs, ClinOne’s CEO. We realize that many trials are not designed to function outside of a research site today; however, many studies including registry studies, can be managed in a near virtual capacity.