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.
For a number of years, Angelo Tinazzi, Senior Director of Statistical Programming at Cytel, has authored the series “The Good Data Doctor” on data submission and data integration, such as ISS and ISE.
Angelo is a leading global expert on CDISC, in particular, the Analysis Dataset Models (ADaM) and Study Data Tabulation Models (SDTM). His lively insights and deep knowledge of submission standards have enabled countless sponsors to have a seamless experience during one of the most critical moments of a clinical trial.
Angelo is a CDISC ADaM Authorized Instructor and a member of the CDISC European Coordinating Committee. This collection features a number of his most critical insights on clinical data standards submission, including:
- From Before to After: Preparing and Concluding Your FDA Data Submission
- In a Virtual Room with the FDA Reviewers
- Watch Out, the FDA Rejection Criteria Are Now in Place
- The Importance of Traceability
- The Integration Dilemma
- More Hidden “Gems”: Raising the Awareness for Additional FDA Data Standards Submission Recommendations
- Regulatory Submissions Support
To read more, click below to download the full publication:
Read more from Perspectives on Enquiry and Evidence:
Sorry no results please clear the filters and try again
CDISC Europe 2023: A Preview
The Facts in the Case of Subject X
(Re)Integration Dilemma: Integrated Summaries of Safety and Effectiveness
