The Near-Future of Regulatory Submissions: Embracing Reproducibility, Open Source, and Interactivity
R in Pharma 2024 Workshop
🗓 October 28, 2024 | 9:00am - 11:30pm EDT
🏨 Virtual
💥 FREE workshop registration
Overview
In this workshop, we will explore the future of regulatory submissions, focusing on three pivotal advancements: full reproducibility, open-source technologies, and interactive data capabilities. We’ll examine how Continuous Integration and Continuous Deployment (CICD) and containerization are transforming submissions by enabling reproducible, automated processes. We’ll then look at how open-source tools and R packages are reshaping clinical reporting, offering flexible, transparent solutions. Finally, we’ll dive into interactive data tools like {teal} and Shiny, showcasing their role in dynamic data exploration and visualization.
Learning objectives
After a vision-filled motivational introduction, and through a succession of practical examples, this session will empower R developers, data scientists, and clinical researchers to adopt innovative, future-ready approaches.
Is this course for me?
Ever wondered how clinical trials reporting may look in the future? Are you interested in learning about some of the latest tools and technologies transforming regulatory submissions? Do you want to explore the potential of R in clinical research? If you answered yes to any of these questions, this workshop is for you!
The workshop is not designed only for those who are masters in R. We will bring you along an intuitive path to produce reproducible (and interactive) reports.
Prework
Before attending the workshop please check our posit cloud work space and create your own assignment. All packages needed are already installed there (it is a clone of the exercise folder).
Additional resources
Where to find more on NEST
Source code of all our packages: https://github.com/insightsengineering
NEST is part of https://pharmaverse.org/
Check cardinal
Check TLG-catalog for hundreds of ready-made TLGs
Check teal.gallery
Collaborate
How can I get involved?
Notice a 🐛 or an idea for enhancements💡? Get in touch!
- We encourage you to collaborate with us and contribute our code base can be found here: https://github.com/insightsengineering
🖮 You can get in touch with us on slack #pharmaverse-pkgs channel here
📧 or contact Leena our product owner if you are interested in industry collaboration (leena.khatri@roche.com)
Instructors
Davide Garolini (he/his) is a Statistical Engineer with an M.Phys. in Biophysics and a Ph.D. in Computational Neuroscience, has over ten years of R programming and package development expertise, specializing in clinical data analysis and regulatory deliveries. He significantly contributes to the NEST project by improving key tools like {rtables}, {tern}, and {gtsummary} for regulatory compliance. Davide strongly advocates for open-source collaboration, promoting advancements in clinical research.
Leena Khatri (she/her) is a Senior Data Scientist in Product Development Data Sciences at Roche. She is currently the Product Owner of the NEST data sciences expert team and associated packages such as {rtables}, {tern}. In addition she leads statistical programming teams, supporting late phase programs in Immunology. Leena is a strong advocate for the end to end usage of R in clinical reporting.