Toll-gates are similar to milestones since they reflect an important event during the course of the project. Toll-gates, however, are critical events that need special attention of and go/no-go decision-making by the User, the Steering Committee (SC) and other stakeholders because the fulfilment and approval to continue the project has significant impact on time and resource allocation for the next project phase. It is therefore required to prepare a Toll-Gate-Decision Document (TDD), summarizing the work performed to date and describing the planned work (incl. budget, resources, risk, and deliverables) until the next toll-gate. Examples for toll-gates in pharmaceutical development are:
- Progress a lead candidate to in vivo preclinical studies
- Initiate the nonclinical development programme, incl. GMP-production
- Initiate clinical phase I (first-in-man) studies
- Initiate clinical phase II (efficacy in target population) studies
- Initiate clinical phase III (pivotal) studies, incl. full GMP-process validation and manufacturing of GMP-validation batches
