TrialConsent is an electronic informed consent solution (eConsent) integrated within the company’s electronic clinical outcome assessments (eCOA) platform. It is also offered as a standalone solution.
According to Bill Byrom, VP of product strategy and innovation at CRF Health, in global, multicenter studies, there are many versions of each consent form reflecting the required country, language, and site differences.
An electronic system to manage documents and information can provide transparency and efficiency, he said.
“Ambiguous consent documentation, such as lack of clarity on the consent date or missing signatures, can lead to the loss of the ability to retain and analyze data collected for that patient, in addition to being a possible cause of warning letters,” said Byrom.
CRF expects eConsent adoption to increase by 30% CAGR between 2017 and 2020 reaching 82%.
The new platform includes a proprietary design tool which allows for collaboration on informed consent documentation and forms.
Additionally, it enables remote monitoring through real-time dashboards and provides time-stamped interaction for documentation of consent and any other data provided.
“CROs can embed the solution within their own processes and develop new service-line revenues and value-added components to offer to sponsor clients,” said Byrom.
Byrom said the new platform uses visual, interactive, and multimedia approaches to convey study information. He argued that patients will be better informed with the use of an interactive media platform, and better-informed patients have greater retention rates: “A common reason for study withdrawal is poor understanding of the study and its requirements,” he added.