Financially Sound Drug Development Decisions
QUOTES (Quantification and Optimization of Trial Expectations Simulator) helps program development teams estimate the financial impact of trial design decisions. By simulating Phase 2 and Phase 3 trial outcomes, QUOTES calculates expected Net Present Value (eNPV) and Return on Investment (ROI), enabling innovative, data-driven strategy.
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Forecast Financial Impact with Confidence
Get detailed projections for eNPV and ROI to quantify the financial impact of your clinical development strategy before trials begin.
Simulate Phase 2 & 3 Success
Model Phase 2 and Phase 3 outcomes to see how design choices affect trial success, timelines, and costs — and make smarter, data-driven decisions.
Optimize Strategy for Maximum ROI
Compare trial sizes, designs, and go/no-go criteria to identify the strategy that maximizes ROI, reduces risk, and shortens development timelines.
How QUOTES Works
QUOTES enables data-driven financial forecasting for clinical development by modeling the financial impact of different trial strategies. Here’s how it works:
- Simulate Phase 2 Trials: Use tools like FACTS to simulate a range of Phase 2 trial designs, including variations in sample size, dose selection, and treatment populations.
- Model Phase 3 Outcomes: QUOTES uses Phase 2 results to predict Phase 3 outcomes, including trial success rates, costs, and timelines.
- Aggregate Results: Calculate key financial metrics such as Net Present Value (eNPV), Return on Investment (ROI), and overall trial performance for each design option.
- Compare Strategies: Evaluate and compare multiple strategies, including trial size, design, and go/no-go criteria, to identify the most profitable development approach.
By running thousands of simulations, QUOTES allows teams to visualize the financial trade-offs of different design choices. This approach makes it easier to justify trial decisions to stakeholders and ensure development plans are optimized for profitability and efficiency.
Comprehensive Financial Forecasting
Unlike traditional clinical trial planning tools, QUOTES focuses on the financial impact of drug development decisions. This allows clinical and financial teams to see how early decisions in Phase II affect the overall cost, risk, and success of the entire drug development program.
Key financial metrics provided by QUOTES include:
- Net Present Value (eNPV): The estimated financial value of a development program, accounting for time, risk, and expected returns.
- Return on Investment (ROI): A measure of the profitability of different trial designs, helping teams identify the approach with the highest financial return.
- Time & Cost Projections: Detailed forecasts of how long trials will take and how much they will cost, enabling more efficient planning and budgeting.
These forecasts are critical for C-suite executives, project managers, and financial decision-makers tasked with evaluating the financial viability of drug development programs. QUOTES helps statisticians communicate effectively with executives by bridging the divide between statistical efficiency of the trial and the increase in expected profit it creates.
Key Features & Benefits
QUOTES offers a unique combination of financial forecasting and adaptive trial planning. Here's some of QUOTES key features and benefits:
- Fully Featured Cost Model: Calculate the cost of the trial including subjects, sites, duration, early phase trials, post market studies, and more.
- Dynamic Revenue Model: Estimate annual revenue as a fixed quantity or as a function of the effectiveness of the therapy including probability of regulatory approval and market exclusivity duration.
- Comprehensive Simulation: Model Phase 2 and Phase 3 outcomes, showing how early trial choices impact downstream results.
- Seamless Integration: Use QUOTES alongside other trial design tools like FACTS to integrate Phase 2 and Phase 3 simulations into a single analysis.
- User-Friendly Interface: Simulate, analyze, and visualize financial metrics from one simple, intuitive dashboard.
These features give drug development teams a holistic view of trial strategy, allowing them to make more confident, data-backed decisions.
Why QUOTES Stands Out
QUOTES is more than just a forecasting tool — it’s a decision support system that enables clinical development teams to make Innovative, faster, and more profitable trial design decisions. Here’s why QUOTES is trusted by biostatisticians, pharmaceutical companies, and CROs alike:
- Innovative Go/No-Go Decisions: QUOTES enables unbiased comparisons of different trial strategies, helping teams identify when to move forward or pivot.
- Cost Savings: By avoiding over-sized trials and inefficient designs, QUOTES reduces unnecessary expenses and shortens development timelines.
- Risk Reduction: See how different design choices impact risk, success probabilities, and downstream effects on Phase 3.
- Stakeholder Alignment: Justify trial strategy to C-suite executives, regulatory agencies, and financial stakeholders with clear, data-driven insights.
By providing visibility into the financial and operational impacts of trial decisions, QUOTES gives development teams a competitive edge.
Who Uses QUOTES?
QUOTES is designed for clinical development teams, including:
- Biostatisticians: Simulate trial performance and financial outcomes to design more profitable development strategies.
- Project Managers: Track time, costs, and risk factors to create more accurate development schedules.
- CROs (Clinical Research Organizations): Optimize trial strategies for clients, saving time and improving financial performance.
- Pharmaceutical Executives: Support go/no-go decisions with clear, quantitative financial forecasts.
This range of users makes QUOTES a vital tool for both scientific and financial stakeholders.
