Publications by Paweł Przytuła
FDA Compliance in Software Development: Cases Where Poor Software Quality Led to Costly FDA Rejections
If you work in pharma, you know how much time and money go into drug development. The last thing you want is a painful FDA rejection, one that not only costs your company millions but also delays critical treatments for patients who need them.Regulatory rejections can happen for many reasons, such as insufficient clinical evidence, manufacturing an...
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FDA Compliance in Software Development: Cases Where Poor Software Quality Led to Costly FDA Rejections
If you work in pharma, you know how much time and money go into drug development. The last thing you want is a painful FDA rejection, one that not only costs your company millions but also delays critical treatments for patients who need them. Regulatory rejections can happen for many reasons, such as insufficient clinical evidence, manufacturing a...
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What is GxP Validation in Clinical Software Development?
If you’re a biostatistician or clinical software developer, you’ve probably felt the weight of trying to meet GxP standards while navigating the FDA/EMA submission process. It’s not just about getting the software right—it’s about ensuring safety, quality, and compliance, all under tight timelines. It can feel like a lot to juggle. Curiou...
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GxP Validation in Software Development starts from the Definition of Done
GxP validation can be a complex and often misunderstood process, with each company implementing their own unique approach. During a recent roundtable I attended at the R/Pharma Summit in Seattle, there was a recurring theme that stood out to me – every company seems to have their own definition of validation and different validation processes, an...
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Are you buying an apartment? How to hack competition in the real estate market with data monitoring
In the last couple of years, real estate companies have shifted their focus to the digital world, and now almost all investments have an online system showing what apartments are available. This is very convenient for their potential clients, as they can easily become familiar with the apartments on offer. Things become interesting when all avail...
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Alternative approaches to scaling Shiny with RStudio Shiny Server, ShinyProxy or custom architecture.
Shiny is a great tool for fast prototyping. When a data science team creates a Shiny app, sometimes it becomes very popular. From that point this app becomes a tool used on production by many people, that should be reliable and work fast for many concurrent users. There are many ways to optimize a Shiny app like using promises for non-blocking ...
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Data Quality Case Studies: How We Saved Clients Real Money Thanks to Data Validation
Machine learning models grow more powerful every week, but the earliest models and the most recent state-of-the-art models share the exact same dependency: data quality. The maxim “garbage in – garbage out” coined decades ago, continues to apply today. Recent examples of data verification shortcomings abound, including JP Morgan/Chase’s 2...
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rstudio::conf 2020 Takeaways: Updates to tidyeval, Shiny/Sass, shinymeta, parallel processing in R, and more…
The RStudio Conference in San Francisco last month was an amazing experience, and I will definitely attend again next year in Orlando. In this post, Pedro Coutinho Silva and I will share some packages and trends from the conference that might interest members of the R community who were unable to attend. Pawel and Pedro in front of Pedro’s rstu...
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RStudio Connect as a Solution for Remote Data Science Teams
The situation around COVID-19 has forced many countries around the world to adopt social distancing policies. This means that more of the world’s workforce is working remotely than ever before. Data Science teams are no exception. Distributed teams bring unique challenges, and managers may be looking for new tools. In this article we’ll expla...
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RStudio Shortcuts and Tips
Updated: May 2020 by Appsilon Data Science How to Work Faster in RStudio In this article we have compiled many of our favorite RStudio keyboard shortcuts, tips, and tricks to help increase your productivity while working with the RStudio IDE. We’ll also provide information about supplemental tools and techniques that are useful for data scienti...
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