04.18.24 -- You've Chosen Your Vendor(s), But Have You Thought About Their Oversight?

Delve into this overview of the U.S. Food and Drug Administration's START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.

See how digital outcome measures of physical activity collected from DHTs as the primary endpoint in a pivotal cardiopulmonary trial were endorsed by the FDA, marking an important milestone. 

Here, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.

Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.

Consider these practices for addressing challenges and driving improvements for reducing overhead costs, streamlining administrative workflows, and optimizing participant recruitment and retention.

By providing personalized services, Elligo aims to bolster patient engagement, improve retention rates in clinical trials, and expedite the completion of studies.

Rare Disease clinical studies demand a specialized full-service CRO with expertise in enrollment, site selection, and regulatory knowledge, including access to patient registries for accelerated recruitment.