Introduction of the Lean Protocol Process
The Nurocor Lean Protocol process is an end-to-end approach to front load and parallelize clinical trial processes based on a collaborative environment for developing digital study protocols. Standards-driven digital protocol development is essential to the Lean Protocol process. Lean Protocol is based on a parallelized protocol workflow where protocol design, development, and implementation processes are decomposed into a series of gates. In a gated protocol workflow, pre-defined gates with well-defined quality control criteria decide when meaningful parts of a protocol can be locked down, freeing up downstream protocol implementation activities, and thereby improving organizational efficiency and reducing costs.
Introduction of the Lean Protocol Application
The Nurocor Lean Protocol™ application features a configurable workflow process enabling organizations to structure a clinical study protocol as a sequence of independently executable gates, with each gate specifying a logical grouping of study development content and tasks. Lean Protocol enables previously serial processes to run in parallel.
Additionally, processes can be further decomposed into levels; for example, the Feasibility and Recruitment process may be decomposed into Early Indication Feasibility, Protocol Feasibility, and Site Feasibility, with each process level used to further refine the study protocol based on insights gained from prior level execution.
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.
Nurocor provides the industry-leading platform for Digitalized clinical development to help companies bring drugs to market faster. Automating the Nurocor Lean Protocol™ with the Nurocor Clinical Platform delivers a front-loaded, workflow-driven, digital process enabling the parallelization of multiple steps to significantly reduce the time required for clinical development.
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