The FDA released its final bioresearch monitoring (BiMo) guidance for clinical trial inspections but did not add concessions regarding on‑site access or the hazards of electronic access during remote audits, despite stakeholder requests from trade groups such as AdvaMed. The final text largely mirrors the 2024 draft and leaves open questions about how remote and hybrid inspections will be operationalized. Clinical trial sponsors and contract research organizations urged clearer rules to protect proprietary data and clinical site workflows. The guidance’s limited changes maintain regulatory inspection expectations while generating continued industry debate over access and cybersecurity during oversight activities.