eConsent

Cloudbyz eConsent transforms the traditional paper-based informed consent process into a digital, interactive experience on mobile devices. It utilizes multimedia elements and templates to present information effectively and includes feedback mechanisms to ensure participant understanding.

Built on the Salesforce platform, this solution offers features that enhance study team efficiency, provide real-time visibility for sponsors, and improve the patient experience. Participants engage through a question-and-answer-based process, allowing them to communicate directly with study teams via chat or by highlighting unclear text. All interactions are saved for future reference.

The eConsent system reduces participant drop-out rates and enhances compliance with its user-friendly interface, allowing participants to review consent documents at their own pace from home. Quizzes are integrated at various stages to confirm comprehension, with responses tracked to refine questions as needed. The system also tracks consent process progress through detailed metrics and analytics.

Compliance with informed consent procedures is strengthened through standardized electronic signatures, controlled workflows, and adherence to HIPAA and 21 CFR part 11 standards, including features like Audit Trail and Version Control.

Templates for consent forms and checklists ensure consistent processes across studies, improving data quality and reducing audit findings. Participants can securely upload identity documents, with all uploads encrypted and accessible in real-time by study teams.

The solution supports global trials with multi-language options and adjustable text sizing for better accessibility. Participants can log in using a One Time Passcode (OTP) for secure access from anywhere.