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Built with precision for clinical trial professionals

SOC 2 Type II
Prognosis
Back to Documentation
  • Introduction to Prognosis
  • Getting Started with Prognosis
  • How Substance Forecasting Works
  • Creating a New Trial
  • Study Setup and Data Input
  • Scenario Planning
  • Managing Drug Substances
  • Advanced Features
Documentation
Back to Documentation
  • Introduction to Prognosis
  • Getting Started with Prognosis
  • How Substance Forecasting Works
  • Creating a New Trial
  • Study Setup and Data Input
  • Scenario Planning
  • Managing Drug Substances
  • Advanced Features

Creating a New Trial

Start a new trial using the step-by-step wizard or AI-powered document upload.

Overview

Once you are familiar with the Prognosis dashboard and navigation, it is time to create your first trial. Prognosis offers two ways to get started: a guided step-by-step setup or an AI-powered document upload that extracts trial details automatically.


Starting the Trial Creation Flow

From the Trials page, click the Create New Trial button in the top-right corner of the page. This takes you to a dedicated creation screen where you choose how you would like to set up your trial.

You need the appropriate role permissions and an available trial slot on your plan to create a new trial. If the button is disabled, you may need to request access from your workspace admin or upgrade your plan.


Choosing a Creation Method

The creation screen presents two options side by side.

Option 1: Step-by-Step Setup (Recommended)

This is the recommended approach for most users. You manually configure every detail of your trial through an 8-step guided wizard.

Best for:

  • New users learning the platform
  • Trials where you need precise control over every parameter
  • Situations where no protocol document is available

What you get:

  • Full control over every detail
  • Validation at each step
  • Most accurate forecasting results

Click Start Setup to begin. A dialog appears asking you to name your trial.

Option 2: Upload Documents

Upload your trial protocol (or other supporting documents) and let Prognosis's AI extract key details -- countries, recruitment dates, kits, treatment arms, and more -- to pre-populate the wizard for you.

Best for:

  • Quickly setting up a trial from an existing protocol
  • Getting a head start when you have comprehensive documentation
  • Reducing manual data entry

What you get:

  • Support for PDF, images (PNG, JPG), Excel, CSV, and text files
  • Instant AI-powered data extraction
  • A review step before anything is finalized

Document upload and AI extraction are available on paid plans only. If you are on the free plan, this option displays a "Paid Plan Required" badge and the button reads "Upgrade to Unlock." Contact your account administrator or visit account settings to upgrade.


Step-by-Step Setup: Creating Your Trial

When you click Start Setup, a dialog appears.

Trial Name

  1. Enter a name for your trial in the Trial Name field (e.g., PHOENIX-001).
  2. The name is required and can be up to 255 characters.
  3. Click Create & Continue.

The system creates your trial and immediately redirects you to Step 1 of the configuration wizard (Countries & Depots). You can always rename your trial later from the Trials page.

Tip: Use your internal protocol number or study ID as the trial name so it is easy to find later.


Upload Documents: AI-Powered Setup

If you are on a paid plan, click Upload Files on the creation screen to open the upload page.

Uploading Your Files

  1. Drag and drop files into the upload area, or click to open the file picker.
  2. You can upload multiple files at once.

Supported file types:

FormatExamples
PDFTrial protocols, investigator brochures
ImagesPNG, JPG -- scanned documents or protocol pages
SpreadsheetsExcel (.xlsx), CSV -- enrollment data, site lists
TextPlain text files with protocol details

File size limit: 50 MB per file.

Adding a Trial Name (Optional)

Once you have selected files, a Trial Name field appears below the upload area. This is optional -- if you leave it blank, the AI will suggest a name based on the protocol content.

Starting Extraction

Click Extract Data to begin. The system uploads your files and starts the AI extraction process.

Monitoring Extraction Progress

After upload, you will see a real-time progress view with four phases:

PhaseLabelWhat Happens
1AnalyzeThe AI reads and classifies your documents
2ExtractTrial details are pulled from each section
3VerifyExtracted data is validated for accuracy
4FinalizeResults are reconciled and prepared for review

During extraction, you will see each section update in real time:

  • Countries & Enrollment -- country list, patient targets
  • Depot Configuration -- depot setup and distribution
  • Recruitment Schedule -- dates and enrollment rates
  • Kits & Products -- kit definitions and dosing
  • Label Groups -- labeling and country assignments
  • Treatment Arms -- arms, randomization ratios
  • Cohorts -- cohort structure
  • Production Constraints -- manufacturing parameters
  • Actuals Data -- any historical recruitment data (from spreadsheets)

A progress bar and elapsed timer keep you informed. You can also click Continue in background to return to the Trials page while extraction runs -- the process continues automatically.

Reviewing Extracted Data

Once extraction completes, you are redirected to the Review screen. Here you can:

  • See a summary of what the AI extracted for each wizard section
  • Check which sections are complete, incomplete, or missing
  • Edit or correct any extracted values before proceeding
  • Confirm the extraction to enter the wizard with pre-populated data

AI extraction is a starting point, not a final result. Always review the extracted data carefully. Some fields may need manual adjustment, especially complex configurations like cohort titration rules or production constraints.

After confirming, you enter the 8-step wizard with your data already filled in. You can refine each step as needed.


What Happens After Creation?

Regardless of which method you choose, you end up in the same place: the trial configuration wizard, starting at Step 1 (Countries & Depots). From here, you will work through 8 steps to fully define your trial's forecasting parameters.

If you used the upload method, many fields will already be populated. If you used step-by-step setup, you will start with a blank slate and configure everything manually.

For detailed guidance on each wizard step, see Study Setup and Data Input.