05.20.26 -- STREAM Edition: Regulatory Compliance And Trusted AI

Explore ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.

Strong site engagement prevents logistical friction from stalling research. Proactive support and local expertise ensure administrative burdens never stand in the way of clinical progress.

Donna Rivera of Canal Row Advisors stresses that successful and regulator-trusted AI depends on three fundamentals: high-quality, fit-for-purpose data; transparent and explainable models; and cross-disciplinary collaboration to ensure meaningful clinical impact.

The shifting dynamics of clinical research from the current funding dynamic to the increased complexity of drug development, requires a different approach to functional outsourcing to be successful.

Master the complexities of controlled substance handling, over-encapsulation, and dosing strategies to ensure the data integrity and regulatory compliance of abuse potential assessments.

Enable your Data Managers and Medical Monitors to create study-aware custom listings from natural-language requests while maintaining transparency and traceability.

Experience seamless, secure, and flexible eCOA data collection with our application designed for diverse users, compatible with multiple devices, and equipped with offline functionality and robust authentication.

Explore how clinical trial sponsors can benefit from the growing use of electronic source (eSource) technology at research sites.

In this episode of Trials Without Borders, brought to you by Clinical Leader and FlexPoint Bio, host Elena Sinclair and co-host Ross Jackson go beyond the regulatory landscape to tackle the operational questions that determine whether a UK trial runs on time and on budget.