Master Protocols have the capacity for great advantages and efficiencies in drug development over traditional trial protocols but can be challenging for sponsors due to their inherent complexity. Involvement of experienced operational partners can help Sponsors effectively plan and execute their Master Protocols. Focusing on two types of operational partners (Trial Optimisation, Randomisation System), this paper will identify the critical role
that each of these partners contribute to a Master Protocol’s adaptive design features and will provide guidance for the due diligence of operational partner selection.