CRF Health, a global provider of eCOA solutions for the life sciences industry, has launched TrialConsent, an industry-first electronic informed consent solution fully integrated within an eCOA platform. The solution promotes better comprehension, compliance and retention rates while minimizing regulatory risk.
Incorporating recommendations from the FDA’s Guidance on informed consent, TrialConsent enables sponsors, Institutional Review Boards and Ethics Committees, and research sites to achieve better participant understanding of complex information and concepts. Diverse multimedia, tiered information delivery and interactive assessments guide participants through all aspects of the clinical trial to ensure comprehension, thereby improving engagement and reducing costly dropouts.
TrialConsent, a TrialMax platform extension, can be fully integrated with existing eCOA solutions or delivered as a stand-alone solution.
“Electronic methods of informed consent reduce some of the most cited regulatory deficiencies, including patients being admitted as participants prior to or without giving consent; falsified participant responses; the use of unapproved forms; missing data and the inability to produce documentation of consent having taken place,” said Rachael Wyllie, CEO, CRF Health. “For the first time, TrialConsent allows trials to easily integrate informed consent and eCOA solutions on the same device, simplifying and providing consistency, control and flexibility to the informed consent process. Designed to increase participant understanding, the solution aims to create better informed participants who are more likely to comply and remain active in a study.”
TrialConsent features a proprietary design tool to facilitate collaboration between sponsors, research sites and IRBs/IECs while streamlining consent development, approval and deployment. The technology ensures patients receive consistent, up-to-date and accurate information, while enabling remote monitoring of the process through real-time dashboards. The solution also tracks and time-stamps interactions, supporting better documentation for each consented participant.
