Accelerating study start-up through a unit-based, stand-alone model

A global top 10 pharmaceutical company partnered with ICON to drive efficiencies in study start-up (SSU) within the United States. The collaboration transitioned from a traditional Full-Time Equivalent (FTE) Functional Service Provider (FSP) model to a unit-based delivery model, leveraging ICON’s proprietary systems, centralised teams, and streamlined processes.

This strategic shift aimed to reduce cycle times, and enhance transparency and scalability across clinical trials. As well as significantly evolving the operating model, ICON, through centralised tracking of key ‘mini’ cycle times, surfaced additional areas of opportunity to further reduced cycle times.

The sponsor identified that SSU timelines in the U.S. were lagging, impacting overall trial readiness and enrolment milestones. Key bottlenecks included:

ICON implemented a unit-based SSU model, assuming full accountability from site selection through delivery of the Critical Document Package (CDP). Key elements of the solution included:

Centralised teams: An agile start-up team to manage transactional activities, supported by specialised roles such as site Contracts Negotiators, Site Owners, and centralized teams providing ICF and quality review support.

Technology-enabled oversight: ICON’s proprietary systems enabled near real-time tracking, risk assessment, and transparent reporting

Global delivery hubs: 80% of SSU resources were based in low-cost regions (e.g., Mexico and India), enabling cost efficiency and scalability

End-to-end ownership: ICON manages all SSU activities post-site selection, including site contacting, budgeting, CDP delivery, and ongoing maintenance (e.g., contract amendments, protocol updates)

The transition to the unit-based model delivered measurable improvements across key performance indicators:

• Over 36% reduction in start-up cycle time: From site selection to CDP approval, cycle times dropped to an average of 141 days
• Increased volume: CDP approvals rose from ~250 in 2023 to a projected 865 in 2024, with an average of 85 CDPs approved per month
• Cost efficiency: 80% of SSU resources were centralised in Mexico, significantly reducing operational costs
• Improved quality and consistency: 100% of CDP reviews and Trial Master File (TMF) filings were completed by centralised specialist team, ensuring standardised quality control
• Agile scalable capacity: The model supported a 3x increase in SSU capacity, enabling the sponsor to meet aggressive study timelines across therapeutic areas. ICON ramped up and down to meet demand.

By transitioning to a unit-based SSU model in ICONs process and systems, the sponsor gained faster site activation, reduced operational complexity, and greater visibility into study progress, ultimately accelerating trial timelines and improving site engagement. This model empowered the sponsor to focus on strategic oversight while ICON delivered consistent, high-quality execution at scale.