Kimberly McElman | Ask an Expert: eConsent Demo with Q&A - Register for Veeva Summit on October 14

This video serves as a promotional announcement for a critical session held at the Veeva R&D and Quality Summit, focusing specifically on the digital transformation of clinical trial processes through electronic informed consent (eConsent). Hosted by Kimberly McElman, the session, titled "Ask an Expert: eConsent Demo with Q&A," is designed to provide a comprehensive, practical demonstration of Veeva’s specialized tools for managing patient consent in a regulated environment. The core components highlighted for discussion are the functionalities of the Veeva eConsent Editor and the detailed patient workflow facilitated by the MyVeeva for Patients platform.

The session’s focus on the Veeva eConsent Editor is highly significant, as this tool is central to ensuring that clinical trial sponsors and Contract Research Organizations (CROs) can efficiently author and deploy compliant consent forms. The demonstration is expected to cover features vital for regulatory adherence, such as dynamic content generation based on study arm or patient demographics, robust version control necessary for audit trails, and the ability to manage multi-language consent forms across global trials. For technology providers, understanding the editor's architecture is key to developing integrated AI solutions, such as automated regulatory text analysis or compliance validation agents that operate within the Veeva ecosystem.

Furthermore, the emphasis on the patient e-consent process within MyVeeva for Patients underscores the industry's shift toward decentralized and patient-centric trials. The session will likely illustrate how patients interact with the digital consent forms—accessing documents remotely, utilizing interactive elements (like educational videos or comprehension checks), and providing legally binding electronic signatures. This workflow is critical for optimizing patient engagement and reducing dropout rates. By analyzing this process, firms can identify strategic points to deploy AI-powered enhancements, such as LLMs to simplify complex medical jargon or intelligent chatbots to answer common patient questions about the consent document, thereby improving clarity and ensuring true informed consent while maintaining GxP compliance.

Key Takeaways:

• Veeva Platform Centrality: The video confirms the continued dominance of Veeva Systems in the clinical operations space, specifically in R&D and Quality domains, validating the strategic importance of specializing in Veeva consulting and integration services for pharmaceutical clients. • Regulatory Compliance Focus: The context of eConsent mandates strict adherence to regulations like 22 CFR Part 11 regarding electronic signatures and records. The session will detail how Veeva’s solution ensures data integrity, auditability, and non-repudiation, which is a core requirement for any custom software or AI solution integrated into this workflow. • MyVeeva for Patients Integration: Understanding the technical and user experience aspects of MyVeeva for Patients is crucial, as this platform dictates the patient interface for clinical data and consent. This knowledge allows for the development of patient-facing AI tools that seamlessly integrate into the existing Veeva environment without disrupting validated processes. • Optimization of Clinical Trial Start-up: Effective eConsent solutions drastically reduce the time and administrative burden associated with paper-based processes. Insights from the demo can inform consulting strategies aimed at optimizing clinical operations by leveraging digital tools for faster site activation and patient enrollment. • AI Opportunities in Content Management: The Veeva eConsent Editor manages large volumes of complex, regulated text. This presents a prime opportunity for Generative AI and LLMs to assist in drafting localized consent forms, summarizing complex protocol details for site staff, or automatically flagging potential compliance risks in draft documents. • Data Pipeline Requirements: The implementation of eConsent generates structured, high-value data (e.g., consent status, version history, time stamps). This necessitates robust data engineering services to integrate this information into broader clinical data warehouses and business intelligence dashboards for real-time operational insights. • Interoperability with Veeva Vault: Since eConsent is part of the larger Veeva Vault Clinical Suite, the session implicitly highlights the need for solutions that ensure seamless interoperability with other modules, such as Veeva eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System), to maintain a unified source of truth. • Validation of Digital Strategy: The high-profile nature of the session at the R&D and Quality Summit confirms that digital consent is no longer a niche technology but a standard requirement for modern, compliant clinical trials, reinforcing the strategic importance of offering specialized digital solutions in this area.

Tools/Resources Mentioned:

• Veeva eConsent Editor
• MyVeeva for Patients
• Veeva R&D and Quality Summit

Key Concepts:

• eConsent (Electronic Informed Consent): The process of obtaining and documenting a patient's voluntary agreement to participate in a clinical trial using digital methods, ensuring compliance with regulatory standards for electronic records and signatures.
• MyVeeva for Patients: A component of the Veeva platform designed to enhance patient engagement and communication throughout a clinical trial, serving as the interface through which patients often access and sign eConsent forms.