COSMOS eConsent transforms the conventional patient consent approach by making the entire process easy, truly patient-centric, and improving transparency. It is designed for decentralized, virtual, and hybrid research projects to help deliver compliant, patient-centric, and site-friendly experiences. Through our digital consent solution, you can offer patients the much-needed flexibility for remote consenting.
Our innovative, regulatory-compliant, and patient-friendly eConsent system automates the entire patient enrolment process. This improves the overall patient consent tracking management, reduces informed consent errors, and eases the administrative burden in research sites and among study teams. Also, it improves the patient experience by granting patients access to easy-to-understand clinical trial information and facilitating patient engagement.
Features
- Traceable and fully compliant with US 21 CFR Part 11 electronic signature requirements
- Increase patient engagement and retention by ensuring critical information is always available at the participants’ fingertips.
- COSMOS built-in video conferencing capability keeps you focused on participants and offers seamless patient enrollment and engagement experience
- Conduct secure (encrypted) peer-to-peer video conversations with industry-leading platform
- Empower patients and research sites with an eConsent solution that improves education, retention, and adherence to the regulatory requirements
Participant safety and data integrity are the most important factors
Increased Transparency and Compliance
All consent records are stored in an encrypted cloud platform with tools for version-controlled file storage, deployment, approval, and strict monitoring. This facilitates a higher level of transparency and compliance across your clinical study patient enrollment and retention. Note that both single and dual in-line signature eConsent/TeleVisit solutions are available with full compliance, audit trails, and reporting.
Benefits of eConsent
Regulatory Compliance: Fully traceable and compliant with US 21 CFR Part 11 electronic signature requirements.
Increased Patient Engagement & Retention: Ensures essential information is always available via the patient portal, fostering engagement and adherence.
Seamless Virtual Enrollments: Built-in video conferencing for streamlined participant interactions and remote consent facilitation.
HIPAA-Compliant Security: Conduct encrypted, peer-to-peer video conversations for a secure and private consenting process.
Trust & Confidence: Strengthen patient and research team assurance in decentralized and virtual trials.
Flexible Deployment: COSMOS eConsent is device-independent, delivering a compliant, efficient, and adaptable workflow solution.
Increased Transparency & Compliance
All consent records are securely stored in an encrypted cloud platform, with tools for version-controlled file management, approval processes, and stringent monitoring. This structure fosters greater transparency and compliance throughout patient enrollment and retention in clinical trials. COSMOS eConsent supports single and dual in-line signature workflows, offering full HIPAA and 21 CFR Part 11 compliance with robust audit trails and reporting features.
Flexibility & Patient Experience
The platform is accessible across multiple device types, providing patients with interactive and engaging multimedia to support informed decision-making. Enhanced Informed Consent Process Principal Investigators PIs and research site teams can leverage COSMOS eConsent to share Informed Consent Forms ICFs and educational materials via the patient portal. COSMOS eConsent integrates effortlessly with existing site infrastructures, enabling quick and efficient deployment. COSMOS built in TeleVisit feature allows site teams to conduct remote informed consent discussions, making the process more accessible and efficient. With COSMOS eConsent Study participants receive consent documents electronically. These resources simplify complex terminology, ensuring patients fully understand study expectations and commitments before enrolling. Patients can review ICFs in real time with the PI or site team. Digital signatures are captured seamlessly, enabling immediate countersigning and electronic storage. Sponsor monitors can verify ICFs remotely, accelerating compliance assessments and reducing protocol deviations. Provides remote consent flexibility while maintaining regulatory adherence. Enhances knowledge transfer through secure, study specific video discussions. Optimized Patient Enrollment for Decentralized Virtual Trials Empowers research sites and participants with an intuitive, patient centric eConsent experience. Enables study specific e signatory workflows for seamless collaboration between PIs, site teams, and participants. With COSMOS eConsent, clinical trial workflows become more efficient, compliant, and patient friendly, supporting the evolution of decentralized and virtual trials.