Advanced Features

Overview

Beyond basic trial forecasting, Prognosis offers advanced features that help you manage complex trial designs and integrate real-world data. This guide covers these powerful capabilities.

Cohort Management

Cohorts allow you to manage distinct patient groups within a single trial, each with its own enrollment window and patient targets.

When to Use Cohorts

Cohorts are valuable for:

• Dose escalation studies — Different groups receiving escalating doses
• Expansion cohorts — Adding patient populations based on interim results
• Adaptive designs — Trials where enrollment strategy may change
• Staggered enrollment — Sequential enrollment of different patient groups

How Cohorts Work

Each cohort represents a distinct group of patients with:

• Defined enrollment window — Start and end dates specific to this cohort
• Patient target — Number of patients to enroll in this cohort
• Treatment assignment — Which treatment arm(s) the cohort follows
• Country allocation — Which countries participate in this cohort

Cohort Forecasting

When cohorts are enabled, Prognosis:

1. Calculates demand for each cohort separately
2. Uses cohort-specific enrollment windows (not trial-level dates)
3. Aggregates demand across all cohorts for production planning
4. Tracks cohort status (Planned, Active, Completed) automatically

Example: Dose Escalation Study

A typical Phase 1 dose escalation might have:

Prognosis will forecast kit demand for each cohort based on its specific timeline, then aggregate for production planning.

Real-Time Data Integration

For in-progress trials, Prognosis can incorporate actual enrollment and inventory data to provide more accurate forecasts.

Real-Time Recruitment

When you enter actual enrollment data:

What You Provide:

• Date of enrollment
• Country
• Number of patients enrolled
• Number of patients screened (optional)

What Prognosis Does:

1. Locks in confirmed enrollment for past dates
2. Subtracts confirmed patients from remaining targets
3. Redistributes projected enrollment over remaining time
4. Recalculates demand based on hybrid actual + projected data

Trial Inventory Tracking

Track actual inventory levels across your depot network:

What You Provide:

• Depot location
• Kit type
• Quantity on hand
• Receipt dates
• Expiry dates

What Prognosis Does:

1. Uses actual inventory as starting point for projections
2. Calculates consumption against real stock levels
3. Identifies true supply gaps (not just projected)
4. Adjusts production recommendations based on current state

Benefits of Real-Time Data

Best Practices for Real-Time Data

• Update regularly — Enter actuals weekly or bi-weekly
• Stay current — Don't let data lag more than 2 weeks behind
• Complete data — Include all enrollment events and inventory receipts
• Verify accuracy — Double-check data entry before generating forecasts

Cost Analysis

Prognosis can estimate trial supply costs based on kit consumption and configured costs.

Setting Up Cost Analysis

1. In the Kits step of the wizard, enter cost per kit
2. Select the appropriate currency
3. Complete the wizard to generate cost projections

What You Get

Cost by Kit Type:

• Total cost for each kit type across the trial
• Cost breakdown by treatment arm

Cost by Country:

• Supply costs allocated to each country
• Based on where kits are consumed

Cost by Time Period:

• Monthly cost projections
• Quarterly rollups
• Annual summaries

Using Cost Projections

Cost analysis helps with:

• Budget planning — Estimate supply chain costs
• Scenario comparison — Compare costs across different strategies
• Financial reporting — Support budget discussions with data
• Optimization — Identify opportunities to reduce costs

Custom Lot Configurations

Pre-schedule specific manufacturing runs or incorporate existing inventory.

When to Use Custom Lots

• Planned production — You've already scheduled manufacturing slots
• Existing inventory — Stock from a previous trial or procurement
• Fixed batches — Contract manufacturing with pre-defined quantities

Configuring Custom Lots

For each custom lot, specify:

How Custom Lots Affect Forecasts

1. Custom lots are treated as fixed supply
2. Prognosis deducts custom lot quantities from demand
3. Recommended production covers only the remaining gap
4. Risk assessment accounts for custom lot timing and expiry

Titration Support

For protocols where patients transition between doses, Prognosis supports titration modeling.

What is Titration?

Titration occurs when patients:

• Start at one dose and escalate to higher doses
• Move between dose levels based on response
• Follow different dosing based on tolerability

Modeling Titration

When titrations are enabled:

1. Define the titration rules (which cohorts patients can move between)
2. Specify the proportion of patients expected to titrate
3. Prognosis calculates kit demand accounting for dose transitions

Advanced Recruitment Patterns

Beyond standard linear and bell curve enrollment, Prognosis supports sophisticated recruitment modeling.

Monthly Recruitment Targets

Define specific enrollment targets for each month:

This provides precise control when you have detailed enrollment plans or historical data.

Bell Curve Variations

Choose from multiple bell curve profiles:

• Standard — Symmetric ramp-up and ramp-down
• Fast — Quick ramp-up, longer ramp-down
• Slow — Gradual ramp-up, quick ramp-down

Screen Failure Adjustment

Account for patients who are screened but don't enroll:

• Set screen failure percentage per country
• Prognosis calculates total screens needed to achieve enrollment targets
• Useful for planning screening kit quantities

Multi-Country Supply Strategies

Optimize supply across complex global trials.

Direct-to-Site vs. Local Depot

For each country, choose:

• Direct to Site — Kits ship directly from central depot to sites
• Via Local Depot — Kits route through a regional depot

Lead Time Optimization

Prognosis calculates optimal production timing by:

1. Finding the longest lead time path in your network
2. Working backwards from demand dates
3. Recommending production start dates that ensure on-time delivery

Country-Specific Overage

Set different safety stock levels by country:

• Higher overage for countries with supply chain challenges
• Lower overage for nearby, reliable supply routes

Data Export and Reporting

Export Options

Export analytics data for offline use:

• PDF Reports — Formatted for stakeholder presentations
• Excel/CSV — Detailed data for custom analysis

What's Included

Exports include:

• Trial configuration summary
• Demand projections by month, country, and kit
• Production recommendations
• Risk assessment details
• Cost analysis (if configured)

Integration Capabilities

For organizations needing deeper integration:

• API access for programmatic data retrieval
• IRT system integration (coming soon)
• Custom reporting solutions

Contact us for enterprise integration options.

Getting Help

In-App Guidance

• Information icons (ⓘ) — Hover for explanations of metrics and fields
• Validation messages — Guidance when inputs need attention
• Contextual help — Tips throughout the wizard

Support

For questions or assistance:

• Contact your Prognosis account representative
• Email support@useprognosis.com
• Visit our help center for FAQs and tutorials

Feature Requests

Have ideas for new capabilities? We'd love to hear from you:

• Submit feature requests through your account representative
• Provide feedback directly in the platform
• Join our user advisory program for early access to new features

Summary

Prognosis grows with your needs—from simple trial forecasts to complex multi-cohort studies with real-time data integration. These advanced features help you:

• Manage complex trial designs with cohorts and titration
• Improve forecast accuracy with real-time actuals
• Plan budgets with cost analysis
• Optimize supply strategy with flexible lot configurations
• Handle global trials with sophisticated distribution modeling

Explore these features as your forecasting needs evolve, and don't hesitate to reach out if you need guidance on applying them to your specific situation.