Study Setup and Data Input

Overview

The Prognosis wizard guides you through 7 steps to fully configure your clinical trial forecast. Treatment can also open two optional sub-steps, Cohorts and Titration. 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.

Country and Depots

The first step. Configure your trial's geographic footprint and distribution network. You will set up your central depot (the primary manufacturing or distribution hub), add the countries participating in your trial, optionally configure local depots for regional distribution, and define shipping lead times between locations. Each country also requires site-level settings such as the number of clinical sites and site lead times.

For detailed configuration instructions, see Countries & Depots.

Recruitment

The second step. Define when and how patients will enroll in your trial. For each country, you specify the expected number of patients, the First Patient In (FPI) and Last Patient In (LPI) dates, and the enrollment distribution pattern (Standard, Slow Start, Fast Start or Linear curve, or exact Monthly counts). You can also configure a screen failure rate if your trial has a screening phase.

For detailed configuration instructions, see Recruitment Configuration.

Kits

The third step. Define the investigational products and materials used in your trial. Each kit type includes a name, category (Active, Placebo, Comparator, etc.), quantity, shelf life, and optional cost information. Most trials require multiple kit types, and you can add as many as needed.

For detailed configuration instructions, see Trial Kits.

Label Groups

The fourth step. Organize countries by their labeling and packaging requirements. Different countries often have different labeling needs (language, regulatory text), and label groups help you plan packaging runs efficiently and track inventory by label variant. Every country needs a label group.

For detailed configuration instructions, see Label Groups.

Treatment

The fifth step. Define your trial's treatment protocols, visit schedules, and kit dispensing rules. Each treatment arm has a name, allocation percentage (for randomization), a visit schedule (consistent or custom intervals), and kit assignments per visit. You can also configure drop-out rates at each visit to account for patient discontinuation. The Study design: row at the top of the step turns on the optional Cohort and Titration sub-steps.

For detailed configuration instructions, see Treatment Arms.

Cohorts and Titration

Two optional sub-steps of Treatment, added right after it when you turn them on (5.1 and 5.2 with both on). Cohorts splits the enrolled population into groups, each with its own treatment arms, countries and patient counts. Titration models patients moving between dose levels: one titration per kit type for the whole trial, shared by every arm that dispenses that kit.

For detailed configuration instructions, see Cohorts & Titration.

Production

The sixth step. Configure manufacturing parameters and supply constraints. This includes production lead time, safety stock and overage percentages (global, per country or per depot, with per-kit overrides), site seed amounts, and optional custom lots for production runs you already know are coming. Inventory you already hold is entered in Actuals, not here.

For detailed configuration instructions, see Production Constraints.

Shipments

The seventh and final step. Review the DNx cut-offs and the depot and site shipment settings the forecast will use, then continue to Analytics.

Actuals

Actuals is not a wizard step: it has its own page, Actuals (IRT/RTSM), in the trial's left navigation. Once your trial has begun enrolling patients or receiving kit inventory, you can enter actual enrollment numbers and current inventory levels. Prognosis uses this data to lock in confirmed numbers for past dates and recalculate future projections accordingly.

For detailed configuration instructions, see Actuals.

Site Shipments add-on

Site Shipments plans supply down to each site, the way your IRT ships it, and calculates overage instead of asking you to enter it. Every site gets an initial shipment (seed) and automatic resupply from trigger and resupply levels and short and long windows, with DNx cut-offs (DND, DNC, DNS). Overage is everything planned to be produced minus what is dispensed to patients: stock left at sites and depots, expiry and loss.

It is switched on or off for each trial. With it off, the trial plans supply at country level with entered overage and seed, exactly as on the free plan. Sites get their stock from local depots, so Site Shipments needs Depot Shipments: turning Site Shipments on turns Depot Shipments on too, taking a Depot Shipments add-on when the trial holds none. When none is free, Site Shipments cannot be turned on, and its card says why.

Your workspace's add-ons

Each trial with Site Shipments takes one add-on from your workspace. Settings → Add-ons is where add-ons are turned on or off: it lists every study you can see, with its scenarios under it, and shows each add-on's state and how many of the workspace's add-ons are in use. In a larger workspace, search by study or scenario name, filter by which add-ons are on, and select the arrow beside a study to show or hide its scenarios. Searching for a study's name also finds its scenarios.

• On the free plan, the add-on shows as locked, with a link to upgrade.
• A sandbox workspace has unlimited add-ons.
• To add more add-ons to your workspace, contact support@useprognosis.com.
• Hover the info icon beside an add-on's name for a short description, and select it for the full summary.
• Trials that ran Site Shipments before add-ons existed kept theirs, so more can be in use than your workspace holds.
• Turning Site Shipments off keeps the trial's add-on. Deleting the trial frees it, unless one of its scenarios runs Site Shipments: its scenarios become trials of their own, the oldest one running Site Shipments keeps the add-on, and any other one running it has Site Shipments turned off and its Site Shipments inputs deleted. The delete warning names them, and each can be restored from its Activity entry, which takes an add-on. Archived scenarios keep their setting.
• A scenario uses its trial's add-on and takes none of its own. A duplicated trial needs its own add-on; when none is left, it starts with Site Shipments off.

Turn Site Shipments on or off

To start a new trial with it, turn on Site Shipments under Add-ons on the creation screen before choosing Start Setup or Upload Files. For an existing trial or scenario, open Settings → Add-ons and click its Site Shipments status. With Site Shipments off, the trial's Shipments step can also turn it on, but not off. A line at the top of the Production and Shipments steps also says which model the trial runs, with Manage add-ons to open Settings → Add-ons. When a status cannot change, hovering or clicking it says why. After you confirm a switch, its status changes at once and shows a spinner until it is saved; if the switch is refused, the status goes back and a message says why.

When no add-on is left, the status cannot be turned on: contact support@useprognosis.com to add more. Turning it on after the earlier steps are complete lists what the site model still needs (Site Shipments still needs), such as an administration method for every kit, sites for every country with patients, or every site assigned to a strategy, in a message right after the switch.

Switching deletes the inputs of the model you are leaving, after a warning:

Depot settings, such as the depot safety stock and the burst/bulk buffer, belong to Depot Shipments and are never changed by this switch.

Site activation, on site or take-home administration on kits, and depot shipments already Planned or In Transit are kept either way. The change is recorded on the Activity page, where Undo this change on the trial's latest Site Shipments entry brings back the deleted inputs and the previous setting together. The forecast updates in the background after each switch.

What changes in the wizard

With Site Shipments on:

• Kits asks for on site or take-home for every kit and shows Effect on DND. See Trial Kits.
• Production asks for a kit loss rate instead of overage and seed. See Production Constraints.
• Shipments adds the DNx cut-offs and site resupply settings. See Shipments.
• Actuals adds the Site Inventory tab. See Actuals.
• Analytics adds the Site Shipments tab, and Site Strategies, Site Shipments and DNx Settings appear under the trial in the left navigation.

Site activation in Recruitment is available for every trial. See Recruitment Configuration.

A trial with Site Shipments on always forecasts with the site model. If it cannot run, for example because no depot ships a kit to one of its countries, the forecast stops and says what to fix rather than quietly using the country model.

Depot Shipments add-on

Depot planning runs for every trial that ships through local depots, with or without this add-on: Prognosis keeps enough stock at each local depot to cover the shipping time from central, refills it before it runs low, and sizes production to fill those depots. Without the add-on it uses the standard defaults: Min/Max, all kit types shipped together, Min stepping down after the last patient enrolls, and Max at Min plus about four months of demand, with no buffer, safety stock or shipment limits. Trials that ship only straight from central do not run depot planning.

Depot Shipments lets you see and steer those shipments: the Shipment queue in Analytics, the depot settings (Min/Max or Dynamic, stock levels, windows and shipment limits per depot and kit), marking shipments Planned or In Transit, and the workspace's Depot Shipments page across trials. Without it, none of these appear, and the trial is not listed on the workspace Depot Shipments page.

It is switched on or off for each trial in Settings → Add-ons, like Site Shipments, and a trial with no shipment add-on can also turn it on from its Shipments step. Each trial with it takes one add-on from your workspace's Depot Shipments pool. Settings → Add-ons shows the pool, as for Site Shipments: locked on the free plan, unlimited in a sandbox, and trials that had Depot Shipments before add-ons existed kept theirs.

• It cannot be turned off while Site Shipments is on, or while any shipment is Planned or In Transit: return those shipments to recommendations first. The card says how many there are.
• Turning it off, after a warning, puts the depot settings back to the standard defaults. The change is recorded on the Activity page, where Undo this change brings back the previous settings and switch together.
• Turning it off keeps the trial's add-on, so turning it back on takes no new one, and starts from the standard defaults.
• Scenarios, duplicates and deletions follow the same rules as Site Shipments. When a trial is deleted, the scenario that keeps its Site Shipments add-on also keeps its Depot Shipments add-on; otherwise the oldest scenario with a Planned or In Transit shipment, then the oldest one running Depot Shipments, keeps it.

After the Wizard

Once you have 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.