White Paper

eConsent for Complex Clinical Trials

eConsent for Complex Clinical Trials

Pages 6 Pages

Master protocol trials multiply consent complexity, requiring patients to sign numerous forms across phases, cohorts, languages, and amendments. Each missed or incorrect signature risks compliance, penalties, and lost data, while manual processes drive cost and confusion. Research shows master protocols average 2.4 consent forms per phase, creating heavy burdens for sites and patients. A feature-rich electronic consent (eConsent) platform streamlines workflows, tracks reconsents, supports onsite and remote signing, and simplifies auditing. By automating and digitizing, eConsent reduces risk, saves time and cost, and improves patient engagement in complex umbrella, basket, and platform studies.

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