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Simplify your Consent Process with ClinConsent

ClinConsent, a Saas eConsent tool to transform the informed Consent Process

ClinConsent removes the risk of mishandled Consent documents and subsequent issues in regulatory inspections. It simplifies the informed consent for sponsors, Site managers, IRB, and Ethics Committees with an easy-to-use technology platform. This dramatically improves the visibility and transperency of the Consent process and leads to improved compliance.

  • A versatile product that can be used on most devices and across different platforms.
  • Simple, user-friendly Electronic Consent. Patient-centric design keeps engagement and adherence up, while site staff is freed from time-consuming explanations and able to focus on higher value patient-focused efforts.

As technology becomes more active into the everyday processes of clinical research, make sure to stay on the lookout for even more crucial advancements to eConsent Technology in research.

What is Electronic Informed Consent (eConsent)

Informed Consent is a voluntary agreement to participate in research. Informed consent involves providing a potential subject with adequate information about the research to allow for an informed decision about the subject’s voluntary participation in a research study. Patient inspections resulting in an FDA Form 483

All these interactions between patient and the study volunteers would be in paper documents which will be hard and timeconsuming and probably would sign the documents without understanding. The paper documents could be lost or hard to recover the massive amount of documentation.

Electronic documentation of consent may be used when researchers conduct the consent process with participants in person, as well as when potential participants are not physically present during the consent process.

But what makes electronic informed consent different from paper consent form is

  • Makes it easier for both Sites and Patients
  • Multiple Language Support
  • Multimedia for better understanding
  • Able to reach patients globally
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Clinconsent ensures a seamless patient journey and consistent user experience across all stages of the study with tired consent and re-consent process, and the only electronic informed consent solution that can serve as a standalone solution or fully integrat with EDC or EHR platform.

Features and Benefits

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FDA guidance on Electronic Informed Consent

  • The eIC must contain all elements of informed consent required by HHS and/or FDA regulations (45 CFR 46.116 and 21 CFR 50.25).
  • Process should be easy, Electronic informed consent should be easy to understand, any eIC should be easy to navigate, allowing the user to proceed forward or backward within the system and to stop and continue at a later time.
  • Ensure protection of the rights, safety, and welfare of human subjects

Simplify your Consent Process with ClinConsent