Streamlining Consent Process Digitally

electronic Consent

Participant engagement is crucial for the success of a clinical trial. ResearchManager eConsent fosters participant engagement in a positive manner while maintaining the integrity of the research. Instead of scattered paperwork like consent forms, eConsent provides an organized and accessible solution.

Information Flow and Participant Consent

ResearchManager eConsent provides participants with the ability to digitally access essential research information before consenting to participate. This not only promotes transparency but also ensures a better understanding of the research, realistic expectations, and an improved participant experience. As a result, research teams can manage the consent process efficiently and ethically.

eConsent Increases Engagement

Information is key, especially in clinical research. Active engagement is crucial. With multimedia tools such as explanatory videos, participants can easily access essential information about their research and involvement. This enhances satisfaction and results in better and more comprehensive responses.

eConsent Meets Legal Requirements

Working with participants entails additional requirements from the law for patient safety and secure data management. eConsent is secure and complies with regulatory standards and legislation, such as GCP. Additionally, eConsent provides documentation of the consent process, including digital signatures, audit trails, and secure data storage. This ensures that the research meets submission and inspection requirements, and enables monitoring. Therefore, eConsent safeguards the integrity of the research.

Highlighted features

Customizable eConsent Forms
Customizable eConsent Forms

Create custom eConsent forms tailored to the specific requirements of your study. This feature allows researchers to design consent documents that align with their study protocols and participant demographics, ensuring clarity and relevance in the consent process.

Remote Consent Management
Remote Consent Management

Enable remote consent management capabilities, allowing participants to review and sign consent forms from the comfort of their own homes.

Pre-Consent Information
Pre-Consent Information

Provide participants with access to study information. This allows study participants to review study details, including objectives, procedures, risks, and benefits, ensuring transparency and informed decision-making prior to consenting to participation.

E-Sign Functionality (coming soon)
E-Sign Functionality (coming soon)

Seamlessly integrate electronic signatures into the consent process, enabling participants to digitally sign consent forms. This feature enhances efficiency, reduces paperwork, and streamlines the consenting process for both participants and study staff.

Audit Trail
Audit Trail

Complete audit trail functionality to document all modifications to the data, including the user who made the change, the timestamp of the change, and a detailed description of the alteration.

Users and Partners of ResearchManager

Bilihome
ID3 Medical
Nutromics
Maxima MC
Ingenion Medical
CRA
DataClinic CRO
Amgen
HelixBind
VitroScan
Hawk Biosystems
Sri Ramachandra
University Of Twente
MediaMetrix
Prosoma
Metrics
CDL
The Promise
Inreda
Debrecen
Genetesis
Perfect Lens
Sonion
Bryoptera
Clinique Ovo
Eyecontrol
ETZ
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Compliance and Technical Information

ResearchManager is compliant

  • Offices in the Netherlands (HQ) and in the USA.
  • ISO 27001 certified
  • NEN 7510 certified
  • ISO 14155 compliant
  • 21 CFR PART 11 compliant
  • GCP compliant
  • GDPR compliant
  • HIPAA compliant
  • Secure connection with Comodo’s EV SSL certificate

Information about our Data Centers

  • TIER 3+ data centers in the EU
  • SOC 2 security standards
  • ISO 9001 certified
  • ISO 14155 certified
  • ISO 27001 certified
  • NEN 7510 certified
  • Dedicated backup server, AES 256 encrypted
Thierry Wetting

Thierry Wetting

International Sales Manager

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