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FDA/EMA Inspection - Regulatory Expectations in Early Phase Clinical Trials

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FDA, EMA and other regulatory agencies routinely perform both announced and unannounced phase I clinical investigator inspections, in order to verify the accuracy and reliability of data that has been submitted to the agency, and to provide real-time assessment of the investigator’s conduct of the trial to ensure human safety. Preparing for a clinical inspection involves making sure that all aspects of your clinical trial are up to code. This includes being able to provide all required documents that prove that your trial is GCP compliant. A short summary of SGS CPU experience in ensuring site compliance prior to/during an agency inspection, as well as the importance of conducting site internal quality management will be presented. For more information visit: https://www.sgs.com/CRO and contact us at: clinicalresearch@sgs.com Follow us on LinkedIn: https://www.linkedin.com/company/sgs
Категория: Наука и техника
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