The U.S. FDA rolled out a pilot program designed to speed up early-stage development by pairing drug sponsors with prequalified research institutions. The effort aims to reduce delays between IND preparation and first-in-human enrollment by enabling rolling review of key IND components during the pre-IND phase, alongside parallel work such as protocol assessment by institutional review boards and site activation. Separately, the UK’s MHRA warned that non–Good Clinical Practice-compliant electronic health record systems are harming UK clinical trials. The regulator said sponsors may reject NHS trusts during site selection and that poor eHR compliance could also block data reconstruction needed for marketing authorization applications and publications. Together, the announcements highlight a new emphasis on operational readiness—both at the IND submission stage and in the real-world capability of health systems to support compliant trial documentation and patient recruitment.