CRO Veristat told BioXconomy that the FDA should incorporate first-in-human clinical hold rates into decisions about joining the agency’s qualified research institution (QRI) network. Veristat argued that clinical hold rates reflect cross-disciplinary judgment and IND submission quality across clinical, nonclinical, and CMC components. Under the FDA’s Operation Trailblazer initiative, the QRI network is intended to partner with sponsors to develop and review first-in-human protocols. Veristat suggested applicants provide hold-rate statistics over a defined recent period alongside other submission metrics. For biotech development teams, the message is practical: regulatory track record may become a more explicit selection signal for the institutions that sponsors rely on to accelerate early-phase trials in the U.S.