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Rapid Onboarding for Master Protocols

Facilitating the rapid onboarding of new treatment arms in Master Protocols can be a challenging task for the study’s operational leaders. Thus, being ready for this task is extremely important. To be successful, these leaders need to facilitate a comprehensive understanding across the e-clinical ecosystem to identify all activities required when adding a new treatment.

Typically, the study’s Interactive Response Technology (IRT) system is designed with a flexible randomisation scheme to accommodate new treatments. However, the designated team members who are managing the randomisation must know exactly how it is to be used in practice. In addition, other activities (e.g., medication packaging, shipping, etc.) required for new treatment onboarding must be identified and well-coordinated. To get the involved team ready, it is crucial to crystallise the process broadly in terms that all team members can understand. Effective leaders will foster a collaborative process where teams develop empathy for the objectives and challenges of other team members, vendors, and operations partners.

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