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.
ClinOne offers a complete suite of mobile and web applications to
enhance patient, family, caregiver and site engagement. Currently, our
solutions help support close to 3,000 clinical studies, across 1,900
research sites in 55 countries. If you are interested in learning more
or scheduling a demo, contact us. Visit www.clinone.com
for more information.