Accelerating Study Start Up: Transformative Models for Trial Initiation explores real-world, replicable models that are dramatically reducing clinical trial activation timelines across academic medical centers and national site networks. Fragmented workflows, siloed departments, unclear ownership, and sequential processing routinely delay study start-up and patient access to research. This session demonstrates how institutions have achieved more than a 25 percent reduction in activation timelines and, in some networks, activation in as little as 14 days by redesigning the full start-up pathway from protocol intake through site activation using Lean methodology, parallel processing, centralized staffing models, standardized workflows, early-start coverage analysis, structured service level agreements, milestone dashboards, and just-in-time site activation strategies. Participants will gain practical insight into how transparent tracking, root-cause driven redesign, and innovative activation models can create predictable timelines, reduce site burden, improve accountability, and accelerate patient access to critical therapies without compromising regulatory, financial, or operational quality.

Learning Objectives:

By the end of this session, participants will be able to:

• Identify root causes of study start-up delays and apply Lean strategies, including parallel workflows and standardized feasibility processes, to shorten activation timelines while maintaining regulatory, financial, and operational quality.
• Implement structured governance tools such as early-start coverage analysis, cross-department service level agreements, milestone dashboards, and activation metrics to improve predictability, accountability, and continuous performance improvement.
• Evaluate centralized and just-in-time site activation models to reduce site burden, optimize resource utilization, and accelerate patient access to clinical trials.