Operationalizing Qualified e-Signatures in e-Consent: A Practical Playbook for Global Trials

Still relying on ink on paper in parts of your global trials? Learn how to operationalize a country ready e-signature strategy and when to use qualified vs nonqualified approaches, without adding complexity or risk in mixed modality studies.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/e-Consent

Event overview:

Global trials face uneven electronic signature expectations, making the “last mile” of consent a frequent source of complexity and compliance risk. Many organizations still default to ink on paper in practice, even as they expand digital consenting approaches.

In this webinar, IQVIA experts Sonia Fischer, MHA, MBA, and Dana Liu, MBA, will provide a practical playbook for operationalizing a country ready signature strategy, when to use qualified versus nonqualified approaches, and how to manage the flexibility versus complexity trade off in mixed modality studies without increasing risk. They will also cover what “robust eConsent” requires beyond the signature itself (e.g., authentication, audit trail integrity, and consent lifecycle workflows like amendments/reconsent) so teams can design processes that scale and stand up to inspection.

Three key take-aways

• Build a repeatable, country ready framework for deciding when qualified versus nonqualified signature approaches are appropriate.
• Reduce operational burden in mixed modality studies by managing the flexibility versus complexity trade off with clear rules and visibility.
• Strengthen inspection readiness by designing eConsent workflows that go beyond e-signature to include authentication, audit trails, and amendment/reconsent lifecycle controls.

Speakers:

Sonia Fischer, MHA, MBA
Associate Director, Product Management
IQVIA

Dana Liu, MBA
Associate Director, Product and Strategy
IQVIA

Dana Liu, MBA, is the commercial lead for eConsent at IQVIA, where she drives go-to-market strategy and client engagement for IQVIA’s consent solutions. She works closely with product, regulatory, and commercial teams to help life sciences organizations modernize their approach to electronic consent, from country-level signature strategy to scalable workflow design. Liu brings deep experience in health care compliance and clinical trial technology, with a focus on helping sponsors operationalize digital consent in ways that reduce risk and stand up to inspection.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/e-Consent