www.rednucleus.com contact us at info@rednucleus.com Case Study R&D INSPECTION READINESS – CLINICAL DOCUMENT VERIFICATION AND ALIGNMENT Client Challenge The client, a large global pharmaceutical company, was preparing for an audit by the FDA for upcoming NDA submissions. They had recently migrated document systems and were unable to report on the status of the study documentation and make the necessary updates due to resource constraints. The company required an assessment of the metadata and folder status of clinical documentation for multiple studies and remediation of any irregularities. Some vital metadata were not included in the migration, the metadata needed to be verified and corrected, and the protocol and submission binders needed to be created and populated. Alignment o

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