Glossary

This glossary defines terms used throughout the Prognosis documentation. Terms are arranged alphabetically. If you encounter an unfamiliar word while using Prognosis, look it up here.

A

Actuals -- Real patient enrollment and kit inventory data entered during trial execution, as opposed to forecasted projections. When actuals are present, Prognosis uses real numbers for past periods and forecasts only the remaining future.

Allocation Percentage -- The percentage of randomized patients assigned to a given treatment arm. All treatment arm percentages must add up to 100%. For example, a two-arm trial might allocate 60% to the active drug and 40% to placebo.

B

Batch Size -- The number of kits manufactured together in a single production run. Prognosis lets you set a minimum and maximum batch size. For example, if your minimum is 500 kits, you can order 500, 1,000, or 1,500 kits -- but not 700.

Bell Curve (Enrollment) -- A recruitment distribution pattern where patient enrollment ramps up, peaks in the middle of the enrollment window, and tapers off. Prognosis offers standard, slow (later peak), and fast (earlier peak) bell curve variants.

C

Carry-Forward Inventory -- Kits remaining in stock from previous months that are still within their shelf life and available for future dispensation. Prognosis tracks this automatically using a first-in, first-out (FIFO) approach.

Central Depot -- The primary supply hub in your distribution network -- typically a manufacturing site or global distribution center. All kits originate here before being shipped to local depots or directly to clinical sites.

Clinical Site -- A hospital, clinic, or research center where patients are enrolled and receive treatment. The number of sites per country is an important input that drives enrollment projections and seed stock calculations.

Cohort -- A subgroup of patients within a trial that shares a specific enrollment window, treatment arm, and set of participating countries. Used for phased enrollment (e.g., a safety run-in followed by expansion), dose escalation studies, or staggered regional rollouts.

Confidence Level -- In Monte Carlo simulation, the probability that actual outcomes will fall within a predicted range. A 95% confidence level means that 95 out of 100 simulated scenarios fell within the projected range.

Configuration Complete -- A trial status indicating that all 8 wizard steps have been filled in. This does NOT mean the clinical trial has ended -- it means the trial setup in Prognosis is finished and forecasts can be generated.

Cost of Goods (COG) -- The raw material and manufacturing cost to produce a single kit. One of several cost categories tracked in Prognosis for trial cost analysis.

Cost per Kit -- The total cost to produce and deliver one kit, including manufacturing, labeling, packaging, and distribution. Used in cost analysis to project total trial supply expenses.

Cost per Patient -- The total kit supply cost divided by the number of patients. Helps compare the supply cost efficiency across different trial designs or scenarios.

Coverage (Supply Coverage) -- The percentage of total kit demand that is met by planned supply. 100% or higher means supply is adequate. Between 80-99% indicates tight supply (warning). Below 80% signals a critical shortage risk.

Custom Lot -- A user-defined manufacturing batch with known dates, quantities, and label group assignments. Use custom lots to account for kits that are already manufactured or have confirmed production schedules.

D

Date-Aware Forecasting -- A forecasting mode that activates automatically for in-progress trials. Instead of projecting from scratch, it uses actual historical data for past periods and forecasts only the remaining future enrollment and supply needs.

Days of Supply -- The number of days that current kit inventory can sustain projected demand before running out. A higher number means more buffer; a lower number signals potential shortage.

Demand Plan (DP) -- The configuration of patient enrollment patterns and kit requirements for a trial. Created through the first 5 steps of the wizard: countries, recruitment dates, kits, label groups, and treatment arms. The demand plan drives all enrollment and dispensation forecasts.

Demand Projection -- A time-series forecast showing how many kits will be needed each month, based on enrollment patterns, visit schedules, and treatment arm assignments.

Depot -- A warehouse or distribution center that stores and ships kits. Prognosis supports two types: central depots (main supply hubs) and local depots (regional warehouses). Depots are created in Master Data and assigned to trials during setup.

Direct Shipping (Direct-to-Site) -- A distribution method where kits ship directly from the central depot to clinical sites in a country, bypassing all local depots. Used when a country does not need regional warehousing.

Discontinuation -- When a patient leaves a clinical trial before completing all scheduled visits. Also called "dropout." Discontinuation reduces kit demand for remaining visits.

Dispensation -- The act of giving kits to patients at scheduled visits. Kit dispensation is the core driver of demand in Prognosis -- every kit forecast ultimately predicts how many kits will be dispensed, where, and when.

Distribution Strategy (DS) -- The supply-side configuration for a trial, covering production constraints, safety stock rules, and logistics. Complements the Demand Plan by defining how supply will meet the projected demand.

Dose Escalation -- A titration pattern where patients start at a lower dose and increase to higher doses over time based on tolerability. Modeled in Prognosis using titration rules that specify which percentage of patients transition between kit types at specific visits.

Dose Level -- The specific dosage strength assigned to a patient at a given point in the trial. Patients may move between dose levels through titration (escalation or de-escalation). Each dose level corresponds to a different kit type.

Dropout Rate -- The percentage of patients who leave the trial before completing all visits. A 10% dropout rate means 1 in 10 enrolled patients will discontinue. Prognosis supports a single global rate or different rates at each visit. Higher dropout reduces kit demand for later visits.

Drug Product -- A finished pharmaceutical item manufactured from a drug substance -- such as tablets, capsules, or vials. Drug product batches are tracked through manufacturing stages in Master Data.

Drug Substance -- The active pharmaceutical ingredient (API) or raw material used to manufacture drug products. Tracked in Master Data with batch status lifecycle from planned through consumed.

E

Enrollment -- The process of recruiting and registering patients into a clinical trial. In Prognosis, enrollment is modeled as a time-distributed flow -- patients enter at different rates across countries following configurable distribution patterns.

Enrollment Ramp -- The gradual increase in patient enrollment at the start of a trial, as clinical sites activate and begin recruiting. Most real trials follow this pattern rather than enrolling all patients on day one.

F

FIFO (First-In, First-Out) -- The inventory management method Prognosis uses: kits closest to their expiry date are consumed first. This minimizes waste from expired kits.

First Patient In (FPI) -- The date when the first patient is expected to enroll in a country. Sets the start of the enrollment window.

Forecast -- The primary output of Prognosis -- a projection of patient enrollment, kit demand, production schedules, and inventory levels based on all your wizard configuration inputs. Represents what will happen if everything goes as planned.

Frequency of Production -- How often manufacturing runs can occur -- for example, every 2 weeks or every month. This limits how frequently new kit orders can be placed and affects supply responsiveness.

G

Gross Requirement -- The total production quantity needed before accounting for existing inventory and custom lots. Prognosis calculates gross requirements first, then subtracts available inventory to determine actual production orders.

I

Inventory Level -- The quantity of kits in stock at a given depot or across the supply network at a point in time. Prognosis projects inventory levels forward to identify when and where shortages may occur.

is_complete -- A status flag on a trial, Demand Plan, or Distribution Strategy indicating that the configuration wizard is finished. This does NOT mean the clinical trial has ended -- only that setup is done and forecasts can be generated.

K

Kit -- A packaged unit of medication or placebo given to a patient at a clinic visit. Kits are the fundamental unit of supply planning -- every forecast, inventory calculation, and cost projection answers: "how many kits are needed, where, and when?" Kit types include Active, Comparator, Placebo, Standard of Care, Ancillary, and others.

Kit Type -- The therapeutic category of a kit. Common types: Active (the drug being tested), Comparator (an existing treatment for comparison), Placebo (inactive substance), Standard of Care, Ancillary (supporting supplies), Infusion Bag, and Blinding Sleeves.

L

Label Group -- A set of countries that share the same kit labeling -- same language, regulatory format, and production run. Kits within a label group are identically labeled and manufactured together. Different label groups require separate production batches.

Last-Mile Delivery -- The final leg of kit distribution -- from a local depot or central depot to the clinical site where patients receive treatment. Site lead time represents this delivery duration.

Last Patient In (LPI) -- The date when the last patient is expected to enroll in a country. Sets the end of the enrollment window.

Lead Time -- The time between ordering or shipping kits and their arrival at the destination. Prognosis tracks three types: production lead time (manufacturing), depot lead time (shipping between warehouses), and site lead time (last-mile delivery to clinical sites).

Local Depot -- A regional warehouse that receives kits from a central depot and distributes them to clinical sites or other local depots. Used when countries need regional staging of supply.

Local Depot Group -- A chain of two or more local depots through which supply flows in sequence -- for example, an import warehouse feeding a cold-chain storage facility. Appears as a single node on the network diagram.

Lot -- A specific production batch of kits identified by a lot number. In Prognosis, lots can be custom (user-defined with known dates and quantities) or auto-generated by the forecasting algorithm.

Lot Number -- A unique manufacturing identifier for a production batch, used for regulatory traceability -- for example, "TRIAL-2025-001."

M

Manufacturing Lead Time -- The time required to produce a batch of kits, from order placement to delivery of finished product. Orders must be placed far enough in advance for kits to arrive before they are needed.

Monte Carlo Simulation -- A statistical technique that runs thousands of randomized scenarios (1,000 to 10,000), varying enrollment rates, dropout, manufacturing delays, and other parameters. Instead of a single forecast, it shows a range of possible outcomes and the probability of each -- helping you understand supply shortage risk and right-size safety stock.

O

Overage Percentage -- Extra kits produced above forecasted demand as a buffer against variability. For example, 15% overage means if 1,000 kits are needed, 1,150 are produced. Can be set globally, per country, per depot, or per kit type.

Overage Recommendation -- A Monte Carlo simulation output that compares your current overage percentage against what is needed to meet your chosen service level target. Tells you whether to increase, reduce, or keep your current overage, along with the cost impact.

P

Peak Demand -- The month with the highest projected kit requirement across the trial timeline. Identifying peak demand helps ensure production capacity and inventory are sufficient during the most critical period.

Percentile -- A statistical measure showing what percentage of simulated outcomes fall below a given value. The 50th percentile (P50) is the median -- half of scenarios are above, half below. The 95th percentile (P95) means 95% of scenarios fall below that value. Prognosis displays P5 through P99 in simulation results.

Personal Workspace -- Your individual workspace in Prognosis where you can create and manage trials independently. Separate from team workspaces.

Production Constraints -- The manufacturing rules governing kit supply: how fast kits can be made (lead time), how many per run (batch size), how often runs can occur (frequency), and how much buffer to hold (overage and seed stock). Configured in wizard Step 7.

Production Lead Time -- The time from placing a manufacturing order to receiving finished kits. This is a key constraint -- if lead time is 8 weeks, orders must be placed at least 8 weeks before kits are needed.

Production Run -- A planned batch of kit manufacturing generated by the forecasting algorithm. Each run specifies: start date, kit ready date, quantity, countries supplied, and expiry date.

Q

QC Quarantine -- A holding period during which manufactured kits or raw materials undergo quality control testing. Supply in quarantine cannot be used for clinical distribution until testing passes and the batch is released.

R

Randomization -- The process of randomly assigning enrolled patients to treatment arms according to predefined allocation percentages. Ensures unbiased distribution of patients across treatments.

Real-Time Recruitment -- The actuals data entry step (Step 8) where you input confirmed enrollment numbers, dates, and kit inventory from the ongoing trial. Bridges the gap between forecasted and actual trial execution.

Recruitment Forecast Type (Recruitment Pattern) -- The shape of patient enrollment distribution over time. Options include: linear (even distribution), standard bell curve, slow bell curve (later peak), fast bell curve (earlier peak), custom bell curve (adjustable intensity), and spline curve (fully user-drawn).

Recruitment Mode -- The method for entering patient enrollment targets. Three modes: Enrollment (direct patient counts), Screened (enter screened patients plus a failure rate), and Regional (set targets at the region level, auto-distributed across countries).

Resupply / Replenishment -- The process of restocking kits at depots and clinical sites to maintain adequate inventory levels. Prognosis calculates when and how many kits to resupply based on demand projections and production schedules.

Risk Probability -- In Monte Carlo simulation, the likelihood (expressed as a percentage) that a kit shortage will occur in a given month. A 15% risk probability means 15 out of 100 simulated scenarios resulted in a shortage that month.

S

S-Curve -- An enrollment distribution pattern that resembles the letter "S" -- slow start, rapid acceleration in the middle, then leveling off. Similar to a bell curve but describing cumulative enrollment over time.

Safety Stock -- Extra kits held as a buffer to protect against unexpected delays, demand spikes, or supply variability. In Prognosis, safety stock is managed through overage percentages and seed stock quantities.

Scenario / Scenario Analysis -- A what-if exploration where you adjust trial parameters (production quantities, timing, enrollment assumptions) to see how outcomes change. In the Supply & Demand analytics tab, you can edit production runs in real time to compare scenarios without committing permanent changes.

Screen Failure Rate -- The percentage of screened patients who do not pass the trial's eligibility criteria and are never enrolled. If 100 patients are screened and the screen failure rate is 20%, only 80 patients will enroll. Used in the "Screened" recruitment mode.

Seed Stock (Site Seeding) -- An initial quantity of kits pre-distributed to clinical sites before patient enrollment begins, ensuring sites have supply ready on day one. Calculated as seed amount per site multiplied by the number of sites. Prognosis also handles re-seeding when the previous seed batch approaches expiry.

Sensitivity Analysis -- A simulation output showing which input parameters (enrollment rate, dropout, lead time, etc.) have the greatest impact on trial outcomes like cost or kit demand. Displayed as a tornado chart where wider bars indicate more influential parameters.

Service Level Target -- The confidence level for supply recommendations from a Monte Carlo simulation. A 95% service level means enough supply is recommended to cover 95% of all simulated scenarios. Options: 90%, 95%, 97%, 99%.

Shelf Life -- How long a kit remains usable after manufacture. Configured per kit as a value and time unit (days, months, or years). Determines how far in advance kits can be made and how long they can be stored before expiring.

Shortfall Risk -- A simulation output measuring the probability and expected magnitude of a kit shortage in a given month. Includes P50 (median) and P90 (worst-case) shortage quantities.

Simulation Precision -- Controls the number of Monte Carlo simulation runs: Quick (1,000 runs, approximately 1 minute), Standard (5,000 runs, approximately 3-5 minutes), or High (10,000 runs, approximately 10 minutes). More runs produce more statistically reliable results but take longer.

Spline Curve Editor -- An interactive tool in the recruitment configuration step that lets you draw a custom enrollment distribution by placing and adjusting control points on a graph. Provides full control over the shape of patient enrollment over time.

Stochastic / Stochasticity -- Involving randomness or probability. A stochastic model (like Monte Carlo simulation) incorporates random variation in its inputs to produce a range of possible outcomes, rather than a single fixed prediction.

Stockout -- The projected point at which kit inventory reaches zero -- kits run out entirely and patients cannot receive their scheduled doses. Identifying potential stockouts early is a primary goal of Prognosis forecasting.

Supply Risk -- Any identified threat to maintaining adequate kit supply. Risk types include: timing (kits not arriving when needed), production constraint (batch size violations), depletion (prior demand consuming available supply), expiry (kits expiring before use), and allocation gap (mismatch between allocated and available quantities).

Supply Shortage -- A projected period where kit demand exceeds available supply. Prognosis flags these in the analytics dashboard with severity levels and recommended actions.

Supply Window -- The time period a specific production run covers. Starts when kits from that run arrive and ends at either the kit expiry date or the arrival of the next production run -- whichever comes first.

T

Team Workspace -- A shared workspace in Prognosis where multiple team members can collaborate on trials. Trials created in a team workspace are visible to all members with appropriate permissions.

Titration -- The gradual adjustment of a patient's dose during a trial. Common patterns include dose escalation (increasing dose over time) and dose de-escalation (reducing dose). Modeled in Prognosis as rules specifying what percentage of patients switch from one kit type to another at specific visits.

Titration Rule -- A specific configuration defining: which cohort or arm the rule applies to, the visit number for the dose change, the "from" kit, the "to" kit, and the percentage of patients who make the transition.

Tornado Chart -- A horizontal bar chart used in sensitivity analysis where each bar represents one input parameter. Wider bars indicate parameters with the most influence on outcomes. Helps prioritize which assumptions to refine.

Treatment Arm -- A group in a clinical trial where patients receive a specific treatment or placebo. Each arm has a name, allocation percentage, visit schedule, kit assignments per visit, and dropout configuration. A simple trial might have two arms: "Drug A" (70%) and "Placebo" (30%).

Trial -- A clinical study testing the efficacy and safety of a medication. In Prognosis, a trial is the central entity -- it contains all configuration (countries, patients, kits, arms, production rules) and generates forecasts.

Trial Status -- The current state of a trial in Prognosis. Common statuses: Planning (wizard in progress), Active (trial is running with enrollment underway), and Completed (trial has concluded).

U

Uncertainty -- The inherent unpredictability in trial execution -- patient enrollment may be faster or slower than planned, manufacturing may be delayed, dropout may differ from expectations. Monte Carlo simulation quantifies this uncertainty by showing the range of possible outcomes.

V

Variability -- The natural variation in trial parameters like enrollment rates, patient dropout, and visit timing. Monte Carlo simulation models this variability to show how it affects kit demand and supply outcomes.

Visit / Study Visit -- A scheduled appointment within a treatment arm where a patient may receive kits. Each visit is defined by an offset in days from the patient's treatment start date. The sequence of visits forms the visit schedule.

Visit Schedule -- The full sequence of patient clinic visits for a treatment arm. Can use consistent intervals (equally spaced, e.g., every 2 weeks) or custom intervals (each visit at a different offset). Determines when kits are dispensed.

Visit Window -- In Monte Carlo simulation, a variability parameter (0-7 days) representing how much a patient's actual visit date might differ from the scheduled date. Accounts for the reality that patients don't always arrive exactly on schedule.

W

What-If Scenario -- An exploration mode in the Supply & Demand analytics tab where you can adjust production run quantities and timing in real time to see the immediate impact on supply metrics -- without saving permanent changes.

Wizard Step -- One of the 8 sequential configuration screens for setting up a trial in Prognosis: (1) Countries & Depots, (2) Recruitment, (3) Kits, (4) Label Groups, (5) Treatment Arms, (6) Cohorts, (7) Production Constraints, (8) Actuals.

Workspace -- Your working area in Prognosis. Can be a personal workspace (individual) or a team workspace (shared with colleagues). You switch between workspaces using the account switcher in the navigation.