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 Establishing a successful Contract Research Organization (CRO) in the United States requires far more than laboratory infrastructure; it demands a robust quality system capable of withstanding rigorous federal scrutiny. This guide by Zenovel breaks down the critical 2026 FDA mandates, including Human Subject Protection (21 CFR Part 50/56), Electronic Record Integrity (21 CFR Part 11), and the intricacies of the BIMO inspection program. Learn how to structure your Standard Operating Procedures (SOPs) to ensure operational transparency, financial disclosure accuracy, and seamless data reliability that meets the highest global standards for drug and biologic submissions