A study protocol is a detailed description of a scientific experiment. Lean Protocol (LP) allows the study protocol version under development to be parallelized. In other words, Lean Protocol allows and enables a controlled initiation of downstream tasks in levels based on sign-off of different aspects of the protocol version definitions. In Lean Protocol, these aspects are known as conditions. Instead of waiting for the full study protocol to be specified and approved prior to initiating downstream activities, you can start multiple aspects of the protocol implementation while other sections are being defined, getting you to first patient/first visit much quicker.

The central purpose of the Lean Protocol application is to free up downstream processes as early as possible during study design rather than waiting for the entire study design to be completed and approved. Put another way, Lean Protocol takes an agile approach as opposed to the traditional waterfall approach which is the current practice in the pharmaceutical industry. Upon gate approval, one or more downstream activities associated with the approved process are freed up for working, based on the information provided within the locked study conditions associated with the gate conditions. This enables early action and parallelism within the study design and implementation processes, leading to a faster and less error-prone handover to study execution, more commonly known as First Patient First Visit or FPFV.