Statistical Programming eBook

By Angelo Tinazzi

Engaging in regular technical discussions with the FDA is crucial for data submission success. The purpose is to receive adequate guidance from the agency and resolve all queries prior to the final submission. This helps to bring improved clarity and reduces the need for making corrections at a later stage. Moreover, it is always beneficial to begin these discussions earlier as they can have a positive impact on the agency’s trust. A specialist biometrics service provider can align data management with biostatistics for your studies and help you achieve a successful submission.

For a number of years, Angelo Tinazzi, Senior Director of Statistical Programming at Cytel, has written a series of blogs on our experience with data submission and data integration such as ISS and ISE.

Angelo is a leading global expert on CDISC Analysis Dataset Models (ADaM) and Study Data Tabulation Models (SDTM). His lively insights and deep knowledge of submission standards have ensured that countless sponsors have encountered a seamless experience, during one of the most critical moments of a clinical trial.

Angelo is a CDISC ADaM Authorized Instructor and member of the CDISC European Coordinating Committee. Cytel's latest eBook has a number of his most critical insights on clinical data standards submission 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. The FDA “Real-Time Oncology Review” Process: An opportunity & Challenge for Sponsors

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