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Verisian Blog
Insights on clinical development, submissions and the path to approval. White papers, perspectives, customer stories, tutorials and podcast episodes from Verisian and industry leaders.
Perspectives
Move Submissions Off the Critical Path
Sponsors take months between the last patient last visit of a final pivotal trial (LPLV) and submission, time that sits directly on the critical path for time to market. These months are largely spent on the production and validation of analysis results and the generation of submission documents, before the final submission package is assembled.
Andrew York
Tomás Sabat Stöfsel
Moira Daniels
Customer Stories
How Bayer Uses Verisian AI to Automate Submission Document Generation
Bayer used Verisian AI to automate key submission documentation for a non-CDISC clinical trial, producing submission-ready drafts in under two days and demonstrating how traceability-driven AI can dramatically reduce statistical programming busywork while maintaining regulatory quality.
Podcasts
The Evolution of Statistical Programming: How AI, Open Source & Traceability are Shaping the Future
Andrew York has over 30 years experience as a statistical programmer, and has played a leading role in shaping best practice in the industry. In this episode, Andy shares his unique perspectives on how the role of a statistical programmer has evolved, and how AI, open source, traceability and standards will shape the future of the industry.
Tomás Sabat Stöfsel
September 11, 2025
Podcasts
The Birth of the CRO Industry: How Parexel Transformed Drug Development
Josef von Rickenbach is a true pioneer in the pharmaceutical industry. In 1982, he co-founded Parexel, a company that would go on to define the CRO industry as we know it today. Over the next 36 years as CEO, he led over 40 acquisitions, scaled the company to 19,000 employees, and helped set industry standards that still shape biopharma today.But
Tomás Sabat Stöfsel
March 8, 2025
Podcasts
The End of Double Programming? The Future of Validation in Clinical Trial Analysis
Double programming has long been the industry standard for validation in statistical programming, but is it the most effective approach? In this episode, Henning Kuich, Richardus Vonk, Sunil Gupta and Tomás Sabat Stöfsel discuss how code traceability is transforming the validation process.
Tomás Sabat Stöfsel
February 24, 2025
Podcasts
The Future of R in Clinical Programming
In this episode, we sit down with David, an expert in R programming for clinical trials, to discuss the evolving landscape of statistical programming. He explores the key differences between R and SAS, the critical importance of backward compatibility, and how organizations can future-proof their R-based systems.
Tomás Sabat Stöfsel
February 3, 2025
Product
Introducing Dataset Traceability
Code traceability captures every dataset imported, created, and exported during the execution of your programs. The resulting dependency graph extends across all files in your analysis, letting you seamlessly navigate from TLFs to raw data inputs in seconds. Get full and transparent data lineage for your clinical trial analyses.
August 14, 2025
Product
Introducing Value Traceability
A major milestone in the development of code traceability, the Verisian Tracer now contains and reaches far beyond all traceability concepts defined by CDISC data standards and the define-xml.
August 14, 2025
Podcasts
Automation and AI in Clinical Trial Reporting
In this episode of the Verisian Community Podcast, Shafi shares his over three decades experiences as an expert in statistical programming.
Tomás Sabat Stöfsel
October 8, 2024
Podcasts
The Future of Clinical Trials
In this episode of the Verisian Community Podcast, we welcome Nijat to share how Lindus Health is building the future of clinical trials.
Tomás Sabat Stöfsel
September 23, 2024
Podcasts
Mastering Statistical Programming: Journey, Skills, Challenges, and Future Insights
In this episode of the Verisian Community Podcast, we welcome Sunil Kumar Pusarla to share his journey in the world of statistical programming.
Tomás Sabat Stöfsel
September 9, 2024
Podcasts
Tactical and Strategic Use of AI in the Planning, Evaluation, and Reporting of Clinical Trials
In this episode of the Verisian Community Podcast, we welcome Richardus Vonk to discuss the future of clinical trials.
Tomás Sabat Stöfsel
September 2, 2024
Podcasts
The Limitations and Opportunities of Large Language Models
In this episode of the Verisian Community Podcast, we welcome Ricardo Baeza-Yates, a renowned computer scientist, to discuss the world of Large Language Models
Tomás Sabat Stöfsel
August 23, 2024
Product
Introducing Variable Traceability
Variable traceability is the holy grail in code tracing: it allows you to see everything necessary to understand a variable without any distracting information.
Henning Kuich
August 14, 2025
Perspectives
Metadata Automation is Failing: A Paradigm Shift is Coming
Existing technology, especially the promises around metadata-driven automation (MDA) and metadata repositories (MDRs), will never adequately address the fundamental problems of the industry. They promise to eventually automate 60-90% of all derivations and TLFs (depending on the complexity of the study).
Henning Kuich
August 14, 2025
Podcasts
Navigating Challenges and Unlocking Opportunities as a Statistical Programmer
In this episode of the Verisian Community Podcast, we welcome Daniel Rolo, Director of Statistical Programming at Parexel to discuss the evolving landscape of statistical programming.
Tomás Sabat Stöfsel
April 24, 2024
Podcasts
The New Age Statistical Programmer
In this Verisian Community Podcast episode, we welcome Ritika Aggarwal from Novartis, who shares insights on the evolving landscape of statistical programming.
Tomás Sabat Stöfsel
March 14, 2024
Podcasts
Good Programming Practice in Clinical Programming II
In this episode of the Verisian Community Podcast, we're thrilled to welcome Mansi Thakrar, a Statistical Programmer at Massachusetts General Hospital. This marks our second installment dedicated to discussing good programming practices, where Mansi shares her insights into what constitutes good statistical code in biostatistics.
Tomás Sabat Stöfsel
February 5, 2024
Podcasts
Automation, Generative AI, and Success in Statistical Programming
In this episode of the Verisian Community Podcast, we welcome Shadab from Merck and Rahul from Johnson & Johnson. Our conversation begins with a discussion on the feasibility and desirability of achieving end-to-end automation in clinical programming. We then delve into the world of generative AI, exploring its potential to revolutionize
Tomás Sabat Stöfsel
January 4, 2024
Podcasts
Good Programming Practice in Clinical Programming
In this episode of the Verisian Community Podcast, we welcome Cornelia from Bayer, to discuss good programming practice in clinical programming. Cornelia highlights the critical aspects of writing good SAS code and adapting to languages such as R. Cornelia delves into how Bayer is embracing AI in clinical programming and emphasizes the pivotal role
Tomás Sabat Stöfsel
December 22, 2023
Podcasts
Open Source in Clinical Data Analytics: Challenges, Opportunities
In this episode of the Verisian Community Podcast, Kyle (Syneos) and Oliver (Bayer) discuss the challenges and opportunities of open source in clinical analysis. They look at the importance of people and communication within the industry and the need for a culture change before embracing new systems.
Tomás Sabat Stöfsel
December 10, 2023
Podcasts
Inaugural Podcast: Validation in Clinical Programming
In the first episode of the Verisian Community Podcast, Tomás and Henning, along with industry expert Sunil, discuss how new technology can improve the world of statistical programming. They look at how the Verisian Validation Engine ensures programmers can guarantee the integrity of their analyses.
Tomás Sabat Stöfsel
December 3, 2023