CRF Health Launches TrialConsent, a TrialMax Platform Extension
Product News May 17, 2016
CRF Health, the leading global provider of eCOA solutions for the life sciences industry, launches 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,” commented 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.
For more information on CRF Health's TrialConsent™ solution, please visit www.crfhealth.com.
About CRF Health
CRF Health is the leading provider of electronic Clinical Outcome Assessment (eCOA) solutions for global clinical trials. With experience in more than 800 trials, over 100 languages and across 74 countries, CRF Health’s TrialMax® eCOA solutions consistently demonstrate the industry’s highest data accuracy, patient and site compliance, and patient retention.
CRF Health’s TrialMax eCOA solutions improve trial engagement by fitting into the lives of patients and seamlessly integrating into sites to maximize protocol compliance. Their eCOA solutions include PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes).