E-Signatures and eConsent in Clinical Trials
Download our “eSignature and eConsent in Clinical Trials E-Book” for valuable insights and expert tips on using eSignatures to streamline and optimise your clinical trial workflows.
Download our “eSignature and eConsent in Clinical Trials E-Book” for valuable insights and expert tips on using eSignatures to streamline and optimise your clinical trial workflows.
Discover how to streamline clinical trials with eSignatures and eConsent.
eSignatures streamline the document approval process, allowing researchers, sponsors, and participants to sign documents digitally. This reduces the time needed for obtaining signatures, minimises delays, and enables remote collaboration, speeding up trial timelines.
eConsent allows participants to review, understand, and sign consent forms digitally at their convenience. It enhances comprehension through interactive elements like videos or quizzes, improves accessibility, and enables participants to provide informed consent remotely.
Yes, eSignatures are legally valid in clinical trials when they meet regulatory requirements such as those outlined by the FDA’s 21 CFR Part 11. These regulations ensure that eSignatures are secure, traceable, and auditable, maintaining the integrity of the trial data.
Yes, eSignatures and eConsent platforms use encryption, audit trails, and user authentication to ensure security. These measures protect the privacy and integrity of sensitive data, ensuring compliance with global regulations such as HIPAA and GDPR.