Sunday, January 17, 2010

Clinical and Regulatory CTD Submission QC - Why QC?

Why QC your clinical and regulatory submission - data, documentation, summary module, CTD?

The result of effective QC -
  • The final product, your clinical and regulatory submission is credible, accurate and consistent with previously submitted documents and data worldwide - with QC review - inaccurate data and global inconsistencies are caught and corrected
  • Highly complex, complicated, summarized clinical integrated submission data and documents are inherently prone to errors and inconsistencies - with QC review - these errors are caught and corrected
  • SAS programmed integrated data, tables, listings, graphs and figures, summarized clinical and regulatory submission "storyline" statements, interpretations and conclusions appear sensible, however, clash after many team reviews - with QC review - inconsistent statements, interpretations and conclusions are caught and corrected
  • Module to Module data and documentation errors arise in CTDs - with QC review - intermodular and intramodular errors are caught and corrected
  • Clinical Summary to Nonclinical Summary to CMC Quality Summary - summary to summary inconsistencies arise during the course of submission - with QC review - summary inconsistencies are caught and corrected.

    The QC team are "gate-keepers" of all data and all documents and track errors, statements, interpretations, corrections, versions, etc., so the final data, documents, clinical and nonclinical, CMC summaries, CTD Modules are clear, consistent and accurate and are QC final with respect to QMP, SOP, ICH, CFR, FDA compliance and quality standards.

    The QC team provides a unique opportunity as gate-keepers - the team reviews all data and documentation in the clinical and project submission process while building your CTD. The process of QC is independent of pharma functions and CROs - a clear advantage.

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