CRO Veristat urged the FDA to use first-in-human (FIH) clinical hold rates as a quality metric when selecting organizations for its new qualified research institution (QRI) network. The argument is that hold rate reflects cross-disciplinary IND preparation quality, including clinical, nonclinical, and CMC components. Veristat suggested the FDA compare hold rates over a defined recent period and contextualize them with IND submission counts and modalities. The company tied the proposal to the FDA’s broader “Operational Trailblazer” effort to expand early-stage trials in the US. If adopted, the approach could influence which sites sponsors choose for FIH protocol development, potentially tightening the feedback loop between IND submission discipline and trial initiation speed.