BayBiotech.NET Performing site visits to your CROs for compliance audits at certain time intervals ensures the integrity and quality of data you are receiving for the clinical research. Sponsor audits also set stage for engaged CROs to prepare for direct FDA audits and leads to increased chances of success. Audits may be either routine audits to check the facilities for compliance or may be based on the performance or any non-compliance issue that may have come in the highlight during the course of the study. In either case an audit provides CROs with timely opportunity to take corrective and preventive action measures and makes the CRO facility aware of sponsor’s vigilance leading to compliance on their part as well as best outcomes of financial investment for the sponsor. Before performing an audit, an audit plan must be drafted by the auditor specifically preparing a check list of the items or issues that are recognized as critical steps of the procedures performed at CRO sites.
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