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Preparing and Concluding Your FDA Data Submission, and More Insights on Data Submission and Data Integration

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For several years, CDISC and Regulatory Data Submission expert Angelo Tinazzi has authored the series, The Good Data Submission Doctor, offering his insight and expertise on data submission and data integration. This collection details some of his most critical insights on clinical data standardization, including:

  1. From Before to After: Preparing and Concluding Your FDA Data Submission
  2. In a Virtual Room with the FDA Reviewers
  3. Watch Out, the FDA Rejection Criteria Are Now in Place
  4. The Importance of Traceability
  5. The Integration Dilemma
  6. More Hidden “Gems”: Raising the Awareness for Additional FDA Data Standards Submission Recommendations
  7. Regulatory Submissions Support

Click below to read “The Good Data Doctor on Data Submission and Data Integration”:

 

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