eConsent
Electronic informed consent
In Healthentia a portal user can set up eConsent and eRecruitment functionalities, to conduct virtualized clinical studies.
It provides the ability to easily and quickly complete the process of signing an informed consent under the regulatory framework while ensuring that patients have a better understanding of the clinical trial’s objectives.
Capabilities
Regulatory compliance
Following Good Clinical Practices
Comprehension questionnaire
A comprehension questionnaire is a great way to make sure the trial protocol is well understood
Explanatory Video of study protocol
An explanatory video is a great way to explain trial protocol
Digital signatures
Electronic process of signing
eConsent Components
The investigator can pick from a set of components to configure such as Trial information, images, audio, video, two factor authentication and digital signatures that can assist in the consent process of a patient/user and an organisation.
The investigator from the portal is required to do the double signature to acknowledge the eConsent process.
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Healthentia empowers Sponsors, Sites and CROs to design trials according to any protocol's needs and collect valuable sensor data with a device-agnostic approach. It is ideal for clinical trials Phase III & IV, Observational studies, and Post-market/ Pragmatic studies.
Healthentia is used by Top5 Pharma and large hospitals and operates under the strict regulatory framework of Good Clinical Practice.