Sponsors today face escalating challenges in clinical trial development, including new benchmarks on protocol amendment practices, increased trial cycle times, and significant costs associated with delays. FaaS (Feasibility as a Service) is an expert-led, data-driven assessment designed to determine protocol viability, site selection strategies, recruitment plans, and mid-trial rescue decisions. Powered by Citeline’s Sitetrove and Trialtrove tools, FaaS provides an independent and objective perspective to guide confident decisions, helping sponsors de-risk design, adapt in real time, and keep studies on track without adding operational burden.
Key data highlights include:
- A 260% increase in protocol amendments since 2015.
- Daily costs for Phase II and III trials reaching $40K.
- Trial timelines extending by 3 months between 2020–2024.
- $500K in lost sales daily due to delays.
FaaS combines a phased process with rich, connected data from Citeline’s leading databases and proprietary algorithms. The service offers analysis at multiple stages for strategic decision-making, including:
- Strategize: High-level planning supporting go/no-go decisions.
- Analyze: Leveraging real-world data and proprietary algorithms to enrich patient counts and profiles.
- Analyze & Recommend: Providing insights based on study status, sponsor needs, patient counts, trial capacity, and more.
A case study involving a leading CRO and a global Phase III RCC trial demonstrates FaaS’s effectiveness:
- Analysis identified site-level enrollment lagging by 70% below benchmark rates in 9 out of 10 selected countries.
- Recommendations included additional countries with >5x higher enrollment potential and a list of 120+ high-potential investigators.
- These insights helped secure a rescue engagement and guided post-rescue mitigation strategies.
FaaS is flexible and suitable for any challenge and any phase, ensuring sponsors and their development partners can de-risk design, adapt in real time, and maintain study momentum without additional operational burden.
