Study Setup and Data Input

Overview

The Prognosis wizard guides you through 8 steps to fully configure your clinical trial forecast. Each step builds on the previous one, capturing all the information needed to generate accurate demand projections and supply recommendations.

Pro Tip: Your progress is automatically saved as you complete each step. You can exit the wizard at any time and return later to continue where you left off.

Step 1: Countries and Depots

Configure your trial's geographic footprint and distribution network.

Setting Up Your Central Depot

Your central depot is typically where manufacturing occurs or where kits are released for distribution.

For new users:

1. Click Create Central Depot
2. Enter the depot name and location details
3. Specify manufacturing or release lead times

For returning users:

1. Click Select Central Depot
2. Choose from your organization's existing depots

Adding Countries

1. Click Add Countries
2. Multi-select all countries with clinical sites participating in your trial
3. Countries will appear on the right side of the network diagram

Configuring Local Depots (Optional)

If your distribution network includes regional depots:

1. Click Add Local Depot
2. Select or create the local depot
3. Connect the depot to your central depot (drag to create a link)
4. Connect countries to the appropriate local depot

Defining Lead Times

For each connection in your network, specify:

• Shipping Lead Time — How long it takes to ship kits between locations
• Lead Time Unit — Days, weeks, or months

Country Settings

For each country, configure:

• Number of Sites — How many clinical sites will participate
• Direct Shipping — Whether kits ship directly to sites or via local depot
• Site Lead Time — Time for kits to reach sites from their supplying depot

Click Continue to save and proceed to the next step.

Step 2: Recruitment

Define when and how patients will enroll in your trial.

Enrollment Configuration

For each country in your trial, specify:

Recruitment Patterns

Choose how patients will enroll over time:

• Linear — Steady, even enrollment rate throughout the period
• Bell Curve (Standard) — Enrollment starts slow, peaks in the middle, then tapers off
• Bell Curve (Fast) — Accelerated ramp-up to peak enrollment
• Bell Curve (Slow) — Gradual ramp-up to peak enrollment
• Custom — Define your own monthly recruitment targets

Screen Failure Rate (Optional)

If your trial has a screening phase, you can specify:

• Screen Failure Percentage — Expected percentage of screened patients who won't enroll
• This helps calculate the total number of patients you need to screen

Click Continue to save and proceed.

Step 3: Kits

Define the investigational products and materials used in your trial.

Adding Kit Types

For each kit type in your trial:

1. Kit Name — A descriptive name (e.g., "Active Drug 100mg", "Placebo Kit")
2. Kit Type — Select the category:
   • Active
   • Placebo
   • Comparator
   • Standard of Care
   • Ancillary

Kit Properties

Multiple Kit Types

Most trials have multiple kit types. Click Add Kit Type to add additional kits, then repeat the configuration for each.

Click Continue when all kit types are defined.

Step 4: Label Groups

Organize countries by their labeling and packaging requirements.

Why Label Groups?

Different countries often have different labeling requirements (language, regulatory text, etc.). Label groups help you:

• Plan packaging runs efficiently
• Track inventory by label variant
• Manage country-specific regulatory requirements

Creating Label Groups

1. Label Group Name — A descriptive name (e.g., "EU English", "LATAM Spanish")
2. Description — Optional notes about this label group
3. Countries — Select all countries that use this label variant

Multiple Label Groups

If you have multiple label variants:

1. Click Add Another Label Group
2. Configure the new group
3. Repeat until all label groups are defined

Note: Each country must be assigned to exactly one label group.

Click Continue to proceed.

Step 5: Treatment Arms

Define your trial's treatment protocols, visit schedules, and kit dispensing.

Treatment Arm Basics

For each treatment arm:

Visit Schedule

Define when patients receive kits:

Consistent Intervals:

• Set a fixed interval between visits (e.g., every 28 days)
• Specify the total number of visits

Custom Intervals:

• Define each visit individually
• Useful for protocols with varying visit frequencies

Kit Dispensing

For each visit in the treatment arm:

1. Select which kit type(s) are dispensed
2. Specify kits per visit for each kit type
3. Optionally set a drop-out rate for this visit

Drop-Out Rates

If patients may discontinue treatment:

• Set a percentage of patients expected to drop out at each interval
• The forecast will account for reduced kit demand in later visits

Multiple Treatment Arms

Click Add Treatment Arm to add additional arms. Remember: the total percentage across all arms must equal 100%.

Click Continue to proceed.

Step 6: Cohorts

Manage distinct patient groups with different enrollment windows.

When to Use Cohorts

Cohorts are useful when your trial has:

• Dose escalation phases — Different patient groups receiving different doses
• Staggered enrollment — Groups that enroll at different times
• Adaptive designs — Patient populations that may change based on interim results

Enabling Cohorts

1. Toggle Enable Cohorts to activate this feature
2. Click Add Cohort to create your first cohort

Cohort Configuration

For each cohort, specify:

Cohort Status

Prognosis automatically tracks cohort status based on dates:

• Planned — Start date is in the future
• Active — Currently enrolling (today is between start and end dates)
• Completed — End date has passed

Titration Support

If your protocol includes dose titration (patients moving between dose levels):

1. Toggle Enable Titrations
2. Configure titration rules for how patients transition between cohorts

Click Continue to proceed.

Step 7: Production

Configure manufacturing parameters and supply constraints.

Manufacturing Lead Time

Specify how long it takes to manufacture kits:

• Production Lead Time — Time from starting a batch to having releasable kits
• Lead Time Unit — Days, weeks, or months

Safety Stock & Overage

Configure buffer quantities to protect against supply variability:

Lot Configurations (Optional)

If you have pre-planned manufacturing runs or existing inventory:

1. Click Add Lot Configuration
2. For each pre-planned lot, specify:
   • Kit type
   • Quantity
   • Production date
   • Expiry date
   • Target depot

These fixed lots will be incorporated into the forecast, with Prognosis calculating any additional production needed.

Click Continue to proceed.

Step 8: Actuals

Track real-world data for in-progress trials.

When to Use Actuals

The Actuals step becomes relevant once your trial has:

• Begun patient enrollment
• Received kit inventory at depots or sites

Entering actual data allows Prognosis to provide more accurate forecasts based on real performance rather than projections alone.

Real-Time Recruitment

If your trial has started enrolling patients:

1. Toggle Enable Real-Time Recruitment
2. Enter actual enrollment data:
   • Date
   • Country
   • Number of patients enrolled
   • Number of patients screened (if applicable)

Trial Inventory

If you're tracking inventory levels:

1. Toggle Enable Trial Inventory
2. Enter current inventory at each depot:
   • Depot location
   • Kit type
   • Quantity on hand
   • Receipt date
   • Expiry date

How Actuals Affect Forecasts

When you provide actual data, Prognosis:

1. Locks in confirmed numbers — Actual enrollment replaces projections for past dates
2. Recalculates future projections — Remaining patients are distributed across the remaining enrollment window
3. Updates supply recommendations — Production plans adjust based on current reality

This hybrid approach gives you the best of both worlds: accurate historical data combined with intelligent forecasting for the future.

Click Finish to complete the wizard and generate your forecast.

After the Wizard

Once you've completed all steps, you can:

• View Analytics — Explore your demand forecast, production recommendations, and risk assessment
• Edit Configuration — Return to any step to modify parameters
• Create Scenarios — Clone your trial to test alternative assumptions
• Export Data — Download forecasts for offline analysis or sharing

Continue to Demand Analytics to learn how to interpret your forecast results.