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Top Data Submission and Data Integration Posts of 2023

Perspectives covers a wide range of topics related to data submission and data integration, from ISS and ISE best practices to leveraging automation to the use of Define-XML 2.1, and much more. Here are some of the top topics covered this year:

 

  1. It’s Time to Move, Time to Move to Define-XML 2.1

  2. The Facts in the Case of Subject X

  3. Presenting Clinical Data for Regulatory Submission: A Stats Perspective

  4. Preparing Your Integrated Summaries of Safety and Effectiveness: Best Practices

  5. The Evolution of Open-Source Initiatives and New Standards Development for the Data Submission of the Future

  6. Standards and Open Source Hand-in-Hand: Leveraging Automation to Expedite Drug Market Request Review Process

  7. The Changing Landscape of the Pharmaceutical Industry: A Preview of Cytel’s Contributions at PHUSE EU 2023

  8. Experiencing the CBER: Anticipating Unique Challenges

 

A big thank you to Angelo Tinazzi, who authors the blog series The Good Data Submission Doctor, and Florence Le Maulf for these insightful posts!

If you’re interested in data submission and integration, don’t forget to subscribe to our newsletter below to stay up to date! And take a look at our complimentary ebook, The Good Data Doctor on Data Submission and Data Integration:

 

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