Why use Clinpal eConsent?

Clinpal eConsent removes the risk of mishandled eConsent documents and subsequent issues in regulatory inspections. The patient’s understanding of the study is improved, resulting in increased compliance and retention. The process is more efficient for the site and the patient, making screening and enrollment visits more efficient as the patient is already trained and consented.

As part of the Clinpal platform, Clinpal eConsent ensures a seamless patient journey and consistent user experience across all stages of the study.

Clinpal’s eConsent solution caters to
  • the legal
  • the regulatory and
  • the educational requirements of patient consent in a clinical trial.

21 CFR Part 11 compliant electronic signatures from the patient and investigator provide a record of the confirmation of the completion of the consent form by the patient, confirmed by the investigator.

Clinpal eConsent forms meet all of the requirements defined by the FDA in their eConsent guidance document of Dec 20161 . In addition, the Clinpal eConsent solution allows for a consent configuration to be defined that adapts to the specific regulatory demands in each country supported by your clinical trial.

Educational content is provided with a rich combination of videos, pictures, links, supported by a virtual assistant.

Investigator participation is critical during the consenting process. Clinpal’s integrated messaging system allows the patient to request assistance at any time from the site personnel.

The eConsent platform is suitable for educational paper consent assistance where a paper form is supplemented with electronically delivered education materials for the patient, or as a full electronic consent solution that replaces the traditional paper consent approach.

Clinpal supports desktop, tablet or mobile phone based devices for consent completion.

Clinpal eConsent supports many stakeholders including patients, caregivers, parents, and site personnel.

For more information about the Clinpal eConsent solution,  please enter your contact details below: