Clinical supply planning glossary

Working definitions of the concepts that come up in clinical trial demand forecasting and supply planning — written by practitioners, in plain language. Each entry starts with a definition you can quote, then the context that makes it useful.

• CD&OP (Clinical Demand & Operations Planning)

  Clinical Demand & Operations Planning (CD&OP) is a structured monthly planning process in which clinical operations and clinical supply chain teams align on one shared demand forecast and supply plan for each trial.

• Demand forecasting (clinical trials)

  In clinical trials, demand forecasting is the process of projecting how much investigational product will be needed, where, and when, over the life of a study.

• Buffer stock (clinical trials)

  Buffer stock (or safety stock) in clinical trials is investigational product held above the forecasted demand to absorb uncertainty — faster-than-expected enrollment, shipment delays, temperature excursions, or damaged kits.

• Depot allocation

  Depot allocation is the decision of how to distribute clinical trial supply across regional depots — the warehouses that receive drug from manufacturing or packaging and ship it onward to trial sites.

• IRT / RTSM

  IRT (Interactive Response Technology) and RTSM (Randomization and Trial Supply Management) are two names for the same category of clinical trial system: software that randomizes patients to treatment arms and manages drug assignment and resupply at sites during a trial.