ICON Firecrest have designed a comprehensive approach to electronic informed consent that focuses on what patients want while still addressing the requirements of ICH GCP. Facilitating better understanding of the study information and documenting written consent, Firecrest’s E-Consent is a solution that equally meets the needs of Patients, Sites, Sponsors, Independent Review Boards, Ethics Committees, and Regulatory Agencies.
Based on groundbreaking research sponsored by ICON Firecrest and conducted by Carnegie Mellon University, our eConsent Viewer has been designed to highlight the key pieces of information that influence a patient’s decision to participate in a study. Using video, text, and graphics, this information is presented in an interactive format that actively engages the end-user. Firecrest’s patient-centric videos are a key element of this module. Carnegie Mellon’s research has shown that video outperforms paper in terms of patient engagement in the consent process, knowledge retention of study information, and trust in the physician.
Our eConsent Signature solution uses smart form technology to substantially improve efficiency, oversight, data quality, and compliance within clinical trials. Despite intensive and costly monitoring, 5% of all FDA findings are due to errors in the consenting process. Firecrest’s eConsent virtually eliminates these errors while providing a real-time view of your trial compliance.