Scenario Planning

Overview

Scenario planning allows you to create multiple versions of your trial forecast to test different assumptions and compare outcomes. This powerful feature helps you make informed decisions by understanding the impact of various factors on your supply chain.

Why Use Scenario Planning?

Clinical trials involve inherent uncertainty. Scenario planning helps you:

• Prepare for variability — What if enrollment is faster or slower than expected?
• Optimize production — Which manufacturing frequency best balances cost and risk?
• Evaluate trade-offs — How do different overage levels affect supply security?
• Plan contingencies — What happens if a country drops out or is added?
• Support decision-making — Present stakeholders with data-driven options

Creating a Scenario

From the Trials List

1. Navigate to Trials in the sidebar
2. Find the trial you want to use as a baseline
3. Click the Clone button (or three-dot menu → Clone)
4. Enter a name for your scenario (e.g., "Conservative Enrollment" or "High Overage")
5. Click Create

What Gets Cloned

When you clone a trial, the new scenario includes a complete copy of:

• All country and depot configurations
• Recruitment dates and patient targets
• Kit definitions and properties
• Label groups
• Treatment arm configurations
• Cohort settings (if enabled)
• Production constraints and lot configurations

You can then modify any of these parameters in your new scenario without affecting the original trial.

Editing a Scenario

Accessing the Wizard

1. Click on your cloned scenario from the Trials list
2. Click Edit to open the configuration wizard
3. Navigate to any step you want to modify
4. Make your changes
5. Click Continue to save each step

Important: Always click Continue to save your changes before moving to the next step or exiting the wizard.

Common Scenario Modifications

Here are typical changes you might make when creating scenarios:

Enrollment Assumptions

Production Strategy

Geographic Variations

Comparing Scenarios

Side-by-Side Analysis

To compare scenarios:

1. Open the analytics for each scenario in separate browser tabs
2. Compare key metrics:
   • Total kit demand
   • Number of production runs
   • Risk assessment results
   • Cost projections

Key Comparison Points

When evaluating scenarios, focus on:

Making Decisions

Use scenario comparisons to:

1. Identify the optimal baseline — Which scenario best balances risk and cost?
2. Define contingency plans — If enrollment accelerates, what production changes are needed?
3. Set budget ranges — What's the cost difference between conservative and optimistic?
4. Communicate with stakeholders — Present options with supporting data

Scenario Planning Strategies

Base + Variations Approach

Start with a baseline forecast, then create variations:

1. Baseline — Your best estimate of how the trial will proceed
2. Conservative — Lower enrollment, longer timelines
3. Optimistic — Higher enrollment, compressed timelines
4. High Risk Mitigation — Increased overage and safety stock

Sensitivity Analysis

Test how sensitive your forecast is to specific variables:

1. Create scenarios that change one variable at a time
2. Compare results to understand the impact of each factor
3. Focus planning efforts on high-impact variables

Example sensitivity tests:

• Enrollment rate: +/- 20%
• Shelf life: -2 months
• Lead times: +1 week
• Overage: +/- 5%

Milestone-Based Scenarios

Create scenarios aligned with trial milestones:

• Pre-Trial — Initial planning with projected enrollment
• Post-Site Activation — Updated with actual site counts
• Mid-Enrollment — Adjusted based on actual recruitment rates
• Final — Reconciled with complete actuals

Best Practices

Naming Conventions

Use clear, descriptive names that indicate the scenario's purpose:

Good names:

• "Phase 2 - Conservative Enrollment"
• "Phase 2 - High Overage (25%)"
• "Phase 2 - No Japan"
• "Phase 2 - Q2 2025 Forecast"

Avoid:

• "Copy of Trial 1"
• "New Scenario"
• "Test"

Documentation

Keep notes on what each scenario represents:

• What assumptions differ from baseline?
• Why was this scenario created?
• What decision does it support?

Scenario Hygiene

• Archive old scenarios — Don't let outdated scenarios clutter your workspace
• Update baseline regularly — Keep your primary forecast current
• Limit active scenarios — Focus on 3-5 scenarios at a time

Advanced Use Cases

What-If Analysis

Use scenarios to answer specific questions:

• "What if enrollment in Germany is delayed by 3 months?"
• "What if we reduce overage from 20% to 15%?"
• "What if we add a new treatment arm?"

Budget Planning

Create scenarios for different budget levels:

• Minimum viable — Lowest overage, tightest supply chain
• Standard — Recommended safety margins
• De-risked — Maximum overage, redundant supply

Regulatory Submissions

Prepare scenarios that support regulatory discussions:

• Worst case — Demonstrate ability to supply under adverse conditions
• Expected case — Show planned supply chain approach
• Best case — Demonstrate flexibility to scale if needed

Next Steps

After finalizing your scenarios:

1. Share with stakeholders — Present options and recommendations
2. Make decisions — Select the approach to pursue
3. Update baseline — Apply decisions to your primary forecast
4. Monitor and adjust — As the trial progresses, update with actuals

Continue to Managing Drug Substances to learn about upstream material planning.