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Navigating Regulatory DtP Considerations – From Theory to Practice
Clinical trials are undergoing a paradigm shift towards decentralization, now the participant, rather than site, is at the center of the design and execution of a trial. Direct-to-patient supply is key to enabling clinical trial decentralization, whether partial or full in nature. Enabling DtP requires understanding the regulatory requirements and guidance to streamline planning and ensure a compliant and robust DtP process.
Our speakers will discuss:
- Regulatory Common themes for DtP Planning and Execution
- How to put theory into practice
- Practical DtP considerations, including CRO and participant perspectives