Enforesys®
Simulation-Based Clinical Trial Enrollment Forecasting
Forecast enrollment with confidence. Quantify recruitment risk. Make smarter clinical trial planning decisions.
Move Beyond Static Enrollment Forecasts
Patient recruitment is one of the greatest sources of uncertainty in clinical development. Delays in enrollment can extend study timelines, increase costs, and impact the success of a clinical trial. Recruitment rates vary across countries and sites, study startup timelines differ, patient availability fluctuates, and operational factors such as protocol amendments, competing studies, and site performance issues can quickly alter enrollment trajectories. Traditional forecasting approaches often rely on simplified assumptions and subjective site estimates, making it difficult to accurately predict recruitment milestones, assess enrollment risk, and confidently plan study execution.
Enforesys® 4.0 takes a different approach.
Using advanced Monte Carlo simulation, Enforesys evaluates thousands of potential enrollment scenarios to estimate the probability of achieving recruitment milestones under different operational conditions.
Instead of asking “When will enrollment finish?”, clinical teams can answer the more meaningful question:
“What is the probability that we will achieve our enrollment goals?”
Building on years of successful adoption across the pharmaceutical industry, Enforesys 4.0 represents the next evolution of Cytel’s enrollment forecasting platform, expanding its capabilities through the integration of external clinical trial intelligence while continuing Cytel’s commitment to helping customers improve study planning and operational decision-making.
Simulation-Based Enrollment Forecasting
Move beyond deterministic forecasts by evaluating thousands of possible recruitment scenarios to understand the probability of achieving enrollment milestones.
Real-World Recruitment Intelligence
Replace subjective site estimates with historical site recruitment data to generate more realistic enrollment forecasts.
Scenario Comparison and Optimization
Evaluate different enrollment scenarios, compare study timelines, assess operational trade-offs, and identify the strategy most likely to achieve your study objectives.
Strengthened Feasibility Assessments
Assess whether feasibility projections are realistic using simulation.
Reduced Planning and Reporting Time
Communicate recruitment assumptions, forecast outcomes, and enrollment risk through intuitive visualizations that support stakeholder alignment and decision-making.
Reliably Assess Feasibility
Leverage thousands of simulations that factor into real-world assumptions and uncertainty to understand the probability of achieving milestones.
Powered by the Cytel–Citeline Partnership
Successful enrollment planning depends on two things: Trusted clinical trial intelligence and the ability to understand uncertainty.
Through Cytel’s partnership with Citeline, Enforesys® 4.0 combines both.
The integration of Citeline’s historical clinical trial and site recruitment intelligence with Cytel’s advanced statistical simulation enables pharmaceutical companies and CROs to develop more realistic enrollment forecasts, strengthen feasibility assessments, and improve operational planning.
Rather than relying solely on historical averages or subjective estimates, Enforesys transforms real-world recruitment intelligence into probability-based forecasts that allow teams to evaluate alternative enrollment strategies before study startup.
By combining Citeline’s trusted clinical trial intelligence with Cytel’s proven simulation methodologies, Enforesys provides a more complete understanding of recruitment uncertainty — helping organizations make more informed decisions throughout the clinical development lifecycle.
Read Press Release
The Citeline-Cytel partnership gives customers the best of both worlds. They receive the forecasting and feasibility expertise of Cytel, plus our gold-standard Trialtrove and Sitetrove data. Together, we help remove the guesswork from clinical trial recruitment and enrollment.
Suzanne Caruso
President, Clinical & Strategic Intelligence at Norstella’s Citeline
Upcoming Poster Presentation at JSM — "Enforesys: Real-World Data-Informed Enrollment Forecasting"
Abstract: Accurate enrollment forecasting is essential for effective clinical trial planning and execution. Inaccurate predictions often lead to costly delays and wasted resources as trials may fail to meet enrollment targets. Traditional forecasting methods typically rely on overly simplistic assumptions, such as uniform accrual rates or manually set targets. This fails to reflect real-world recruitment dynamics and leaves critical gaps for teams to address too late. This poster introduces Enforesys, a solution that enhances enrollment forecasting by integrating historical recruitment data with a best-in-class simulation engine. This approach provides a dependable operational planning framework even when forecast uncertainties are unavoidable. We combined flexible enrollment simulations with externally-sourced aggregated historical data to inform initial assumptions. This enables scenario-based planning across sites, regions and recruitment strategies while accommodating trial-specific operational constraints. Our proposed workflow establishes a foundation for more realistic accrual assumptions and supports ongoing evaluation of forecast performance as new data and modeling innovations emerge.
Presented by Julija Saltane, J. Kyle Wathen, and Subhajit Sengupta
JSM, August 3, 10:30AM - 12:20PM
Designed for Clinical Development Teams
Enforesys supports organizations across the clinical development lifecycle, including:
- Clinical Operations
- Clinical Development
- Study Feasibility Teams
- Clinical Program Managers
- Portfolio Planning
- Clinical Trial Managers
- Study Start-up Teams
- CRO Operational Leaders
Select the Strategy That Fits Your Risk Tolerance
There is no single ‘correct’ enrollment target. Enforesys enables teams to choose the strategy that best aligns with their business objectives and acceptable level of risk.
Enforesys enables teams to compare aggressive, balanced, and conservative enrollment strategies by evaluating the trade-offs between study duration, operational risk, and forecast confidence, helping you identify the approach that best aligns with your development objectives.
FAQ
What is enrollment forecasting?
Clinical trial enrollment forecasting estimates how quickly patients will be recruited into a clinical study and predicts whether enrollment milestones are likely to be achieved within planned timelines.
What is Monte Carlo simulation?
Monte Carlo simulation is a statistical technique that models uncertainty by evaluating thousands of possible scenarios using probability distributions rather than fixed assumptions. In Enforesys, it enables more realistic enrollment forecasting and feasibility assessments.
How does Enforesys differ from spreadsheet forecasting?
Traditional spreadsheet models typically produce a single enrollment estimate. Enforesys uses advanced statistical simulation to evaluate thousands of potential recruitment scenarios, enabling teams to quantify uncertainty and understand the probability of achieving enrollment milestones.
How does Citeline data improve enrollment forecasting?
The integration of Citeline’s clinical trial intelligence provides richer historical recruitment data that strengthens the inputs used within Enforesys‘ simulation models, enabling more informed feasibility assessments and more realistic enrollment planning.
Who uses Enforesys?
Enforesys is designed for pharmaceutical companies, biotechnology organizations, and CROs involved in clinical operations, feasibility, study planning, and clinical development.
Request a free demonstration
Discover how Enforesys can help your team evaluate enrollment strategies, quantify recruitment risk, and make more confident trial planning decisions.