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 eTMF study documentation and make the necessary updates. The company required an assessment of the metadata and folder status of clinical documentation for multiple studies within the document system and eTMF and remediation of any irregularities. Some vital metadata was not included in the migration and all the metadata needed to be verified and corrected. Alignment of binders to the global submissions was also needed.

Red Nucleus Solution

The Red Nucleus team utilized their system, clinical, and documentation expertise to develop and execute a plan to deliver the required results. The initial assessment identified gaps in the clinical documentation and associated metadata that needed remediation as well as binders and/or folders that needed to be created and populated. The team developed a plan that included remediation of metadata, creation and population of submission binders/folders, Red Nucleus quality control, and client validation.

Red Nucleus provided recommendations for updates to the metadata, naming conventions, and document versioning and an approach to addressing gaps in the documentation. They established requirements for future alignment/remediation of clinical studies for authority inspections.

Value

Within 5 months, the clinical documentation of the studies for the anticipated FDA inspection were updated in the new document system and submission binders/folders were aligned to match the official submission register. Metadata for the documentation were corrected to match the current client standards.