In Signant’s whitepaper, our in-house experts summarize key themes from the recent EMA recommendation paper on the use of decentralized elements in clinical trials for regulatory submission, including remote informed consent and direct-to-patient medication provision. These recommendations go beyond the extent of the temporary guidance introduced to address COVID-19.

Readers will learn how to leverage perspectives from patients and patient organizations to determine the selection or feasibility of decentralized elements in study designs, maintain reliable, high-quality data when using remote data capture methods, appropriately delegate site and investigator responsibilities, and more. Read our white paper for an overview.