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Discussions with the FDA and Ensuring Data Submission Success

Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions are important to obtain sufficient guidance from the agency and address any concerns before the final submission. This approach enhances transparency and reduces the likelihood of later corrections. Additionally, engaging in these discussions early on is particularly advantageous to improving the FDA’s confidence in your study. To ensure a successful submission, consider collaborating with a specialist biometrics provider who can integrate data management with biostatistics for your studies.

CDISC and Regulatory Data Submission expert Angelo Tinazzi authors the blog series, The Good Data Submission Doctor, offering his insight and expertise on data submission and data integration, such as the ISS and ISE. This week’s featured ebook, The Good Data Doctor on Data Submission and Data Integration details some of his most critical insights on clinical data standardization, including:


  1. From Before to After: Preparing and Concluding Your FDA Data Submission

Planning early discussions with the U.S. Food and Drug Administration is crucial for data submission success, allowing regulatory groups the opportunity to foster the agency’s trust as well as avoid the need for later corrections.

  1. In a Virtual Room with the FDA Reviewers

This chapter shares some lessons learned after a meeting with the FDA as a Data Standards Expert.

  1. Watch Out, the FDA Rejection Criteria Are Now in Place

In 2021, the FDA officially implemented the Technical Rejection Criteria, which could spell trouble for submissions if your eCTD fails to meet these new standards.

  1. The Importance of Traceability

Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. In CDISC, and particularly in ADaM, this crucial component is continuously stressed upon throughout CDISC documentation.

  1. The Integration Dilemma

PHUSE recently released the white paper, “Integration Strategies in Support of ISS/ISE Submissions,” proposing three integration approaches and discussing the pros and cons of each. Which option would you choose?

  1. More Hidden “Gems”: Raising the Awareness for Additional FDA Data Standards Submission Recommendations

It’s important for sponsors and vendors to periodically monitor and carefully review these guidances to keep their organization up to date, but also, most importantly, to assess the impact on existing data governance.

  1. Regulatory Submissions Support

Together with our Data Standards and Data Submission experts, our expert statisticians guide and implement rigorous data pooling and analysis strategies to optimize the likelihood of success.


Click below to read our complimentary ebook, The Good Data Doctor on Data Submission and Data Integration:


Download Publication


The Good Data Doctor on Data Submission and Data Integration is featured as part of our winter Weekend Reads series, which includes complimentary publications on a variety of topics on clinical trial design and data science. Subscribe to our weekly newsletter below and never miss a post!

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