IQVIA Complete Consent

The video introduces IQVIA Complete Consent, an electronic informed consent (e-consent) solution designed to optimize the patient experience, improve retention rates, and ensure regulatory compliance across global clinical trials. The core purpose of the platform is to transform the traditionally outdated paper-based consent process into an engaging, secure, and scalable digital experience. IQVIA emphasizes its extensive experience in e-consent, citing over 15 years in the field and a proven track record of ensuring process integrity, privacy, and security in more than 60 countries, positioning the company as a reliable partner in regulated environments.

The platform achieves its goals by integrating user-friendly multimedia features with a highly scalable e-consent architecture. This design is specifically intended to support study teams managing complex protocols at a global level. A significant focus is placed on the regulatory challenges inherent in global trials; IQVIA positions its experts as partners who help sponsors navigate diverse and complex regulatory environments to deploy e-consent efficiently and compliantly across various sites, thereby driving both compliance and operational efficiency.

A key benefit highlighted is the solution's ability to cater to diverse patient populations and learning styles. By utilizing multimedia, Complete Consent ensures that patients—ranging from pediatric and elderly participants to individuals with physical impairments or those requiring a legal representative—can fully comprehend the details of their participation. This enhanced comprehension is directly linked to higher retention rates, as patients who better understand the commitment are more likely to stay engaged. Furthermore, the digital consent process offers flexibility, allowing patients to complete the informed consent remotely or while on-site, ensuring accessibility regardless of location.

Finally, the video addresses the deployment flexibility of the solution. IQVIA Complete Consent can be implemented as a standalone, self-managed solution, or sponsors can utilize IQVIA’s comprehensive expert implementation support. This partnership approach ensures that sponsors and sites can confidently deliver compliant e-consent globally, maximizing enrollment and engagement while maintaining strict adherence to regulatory standards required in the life sciences sector.

Key Takeaways:

• e-Consent for Operational Optimization: Electronic informed consent is positioned not just as a regulatory necessity but as a strategic tool to optimize the patient experience in clinical trials, directly leading to improved patient retention rates.
• Global Regulatory Expertise: The solution is built upon over 15 years of e-consent experience, ensuring process integrity, privacy, and security across deployments in more than 60 countries, addressing the complex regulatory requirements of global clinical research.
• Multimedia for Enhanced Comprehension: The platform integrates user-friendly multimedia features to transform the consent process, appealing to diverse learning styles and ensuring patients fully comprehend their participation, which is a key driver for higher retention.
• Support for Diverse Patient Populations: The e-consent system is specifically designed to accommodate a wide range of participants, including pediatric patients, the elderly, individuals with physical impairments, and those requiring a legal representative to provide consent.
• Scalability for Complex Protocols: The scalable e-consent platform is engineered to support study teams delivering complex protocols across multiple sites and diverse regulatory jurisdictions worldwide.
• Flexibility in Access: Patients are offered the flexibility to complete the digital informed consent process either remotely from home or physically at the trial site, increasing convenience and removing geographical barriers to participation.
• Expert Regulatory Navigation: IQVIA provides expert support to help sponsors navigate complex regulatory environments, ensuring compliant and efficient deployment of e-consent across various sites globally.
• Deployment Options: Sponsors have flexibility in adopting the technology, choosing between implementing the solution as a self-managed, standalone product or utilizing comprehensive expert implementation and partnership support.
• Compliance and Efficiency Driver: The solution transforms an outdated, manual process into an engaging digital experience that simultaneously drives regulatory compliance and operational efficiency for sponsors and clinical sites.

Tools/Resources Mentioned:

• IQVIA Complete Consent (e-consent platform)

Key Concepts:

• Electronic Informed Consent (e-consent): The digital process of obtaining patient consent for clinical trial participation, replacing traditional paper forms with interactive, multimedia-rich digital documents.
• Patient Retention: The ability to keep enrolled patients engaged and participating throughout the entire duration of a clinical trial, which is significantly improved when patients fully understand the commitment.
• Global Regulatory Compliance: Adherence to the diverse and complex regulatory standards (e.g., FDA, EMA, country-specific requirements) governing clinical trials and data integrity across international borders.