Data integrity requires far more than a strong set of standard operating procedures (SOPs). It demands protocol experts who work closely with all clinical operations departments throughout a study, from start-up to close out. At Alliance Clinical, our quality team partners with staff on all document preparation and completion. They verify informed consent forms, medical histories, treatment histories, eligibility criteria, adverse event reports, primary outcome measures and institutional review board documents. They manage preparation for site monitoring visits, FDA audits, Sponsor audits. They even develop training programs for investigators and clinical research coordinators. Because without data integrity, the trial is meaningless.