As the demand for clinical trials involving advanced and complex therapies continues to expand, many site networks struggle to scale effectively while maintaining quality, operational consistency, and patient access.

This session will address how traditional network expansion models often prioritize site volume over infrastructure maturity and propose strategies for tackling the resulting challenges in study start-up, oversight, execution, and scalability in terms of the operational foundations required to build high-performing site networks capable of supporting advanced therapeutic trials, including rare disease and gene therapy programs. Attendees will examine real-world approaches to strengthening governance, standardizing operational workflows, enhancing site readiness, and balancing centralized oversight with local site flexibility.

Attendees will leave with actionable approaches to strengthen network performance, reduce operational variability, and scale advanced therapy programs more effectively.

CEU: 1.0 ACRP

Speaker:

• Rachana Kanvinde, MS, SFC, CCRP, Director, SPARK CoE, Clinical Trial Access & Partnerships, Tigerlily Foundation