Getting Started with Prognosis

Accessing Prognosis

Creating Your Account

1. Navigate to useprognosis.com
2. Click Sign In in the top-right corner
3. Select Sign Up to create a new account
4. Enter your email address and create a secure password
5. Check your inbox for a verification email and click the confirmation link
6. Once verified, sign in with your credentials

Signing In

If you already have an account:

1. Go to useprognosis.com
2. Click Sign In
3. Enter your email and password
4. You'll be directed to your organization's workspace

System Requirements

Prognosis is a web-based application that works in any modern browser:

• Recommended: Google Chrome or Microsoft Edge (latest versions)
• Supported: Safari, Firefox
• Connection: Stable internet connection required

Troubleshooting: If you encounter login issues, try clearing your browser cookies and cache, then attempt to sign in again.

Navigating the Platform

Once signed in, you'll see the main navigation sidebar on the left side of your screen. Here's what each section contains:

Dashboard

Your command center for monitoring trial performance:

• Portfolio View — See all your trials at a glance with key metrics
• Trial Dashboards — Deep dive into individual trial analytics
• Quick Actions — Access frequently used features

Trials

Where you create and manage clinical trial forecasts:

• Trial List — View all trials in your organization
• Create Trial — Launch the wizard to configure a new trial
• Edit Trial — Modify existing trial parameters
• View Analytics — Access demand forecasts and supply recommendations

Depots

Manage your global distribution network:

• Central Depots — Manufacturing and primary distribution locations
• Local Depots — Regional distribution centers
• Network Configuration — Define shipping routes and lead times

This is your organization's master data—depots created here are available across all trials.

Drug Substances

Plan upstream material requirements:

• Substance Library — Define drug substances and their properties
• Product Mapping — Link substances to drug products
• Trial Associations — Connect products to clinical trials
• Substance Analytics — Forecast total material requirements

Settings

Configure your workspace:

• Organization Settings — Company information and preferences
• User Management — Invite team members and manage permissions
• Notifications — Configure alerts and email preferences

Creating Your First Trial

Step 1: Start the Wizard

1. Navigate to Trials in the sidebar
2. Click Create New Trial
3. Enter a name for your trial (e.g., "Phase 2 Oncology Study")
4. Click Create to launch the configuration wizard

Step 2: Complete the Wizard

The wizard guides you through 8 steps to fully configure your trial:

1. Countries & Depots — Set up your distribution network
2. Recruitment — Define enrollment timelines and patient targets
3. Kits — Configure the kits used in your trial
4. Label Groups — Organize countries by labeling requirements
5. Treatment Arms — Define treatment protocols and visit schedules
6. Cohorts — Configure patient cohorts (optional)
7. Production — Set manufacturing parameters
8. Actuals — Enter real-time data for in-progress trials (optional)

Each step includes helpful guidance and validation to ensure your data is complete and accurate.

Step 3: Generate Your Forecast

Once you complete the wizard:

1. Click View Analytics on your trial
2. Explore the various analytics tabs:
   • Summary — High-level overview of supply requirements
   • Production — Recommended manufacturing runs
   • Patients — Enrollment projections by country
   • Inventory — Stock level forecasts
   • Risk — Potential supply issues

Step 4: Refine and Iterate

Your first forecast is just the beginning:

• Create Scenarios — Clone your trial to test different assumptions
• Update Parameters — Adjust inputs as your plans evolve
• Track Actuals — Enter real data once enrollment begins

Quick Tips for Success

Start Simple

For your first trial, focus on getting the core parameters right:

• Accurate patient numbers and enrollment dates
• Correct kit configurations and visit schedules
• Realistic lead times for your supply chain

You can always add complexity later with cohorts, custom intervals, and lot configurations.

Use Realistic Data

The accuracy of your forecast depends on the quality of your inputs. Work with your clinical operations and supply chain teams to gather:

• Historical enrollment rates from similar trials
• Actual lead times from your logistics providers
• Current shelf life specifications for your products

Leverage Scenarios

Don't just create one forecast—use scenario planning to:

• Compare optimistic vs. conservative enrollment assumptions
• Test different production frequencies
• Evaluate the impact of adding or removing countries

Keep Data Current

For in-progress trials, regularly update your actuals:

• Enter real enrollment numbers as patients join the trial
• Update inventory levels as shipments are received
• Refresh your forecast to see updated projections

Next Steps

Ready to configure your trial? Continue to Study Setup and Data Input for detailed guidance on each step of the wizard.