For Data Monitoring Committee (DMC) reports, Biogen has moved from static, SAS-based reports to interactive R Markdown reports that allow users to immerse themselves in the data during review. While several stakeholders have welcomed this new way of …
This research introduces an innovative GenAI approach to enhance regulatory compliance in the pharmaceutical industry. Faced with evolving FDA and EMA regulations, pharmaceutical companies struggle with manual, error-prone processes for updating …
Product quality plays a vital role in the success of Biotech/Pharmaceutical organizations, and the accurate classification of quality risks is crucial to ensure the delivery of high-quality products. However, the current practice of assigning risk …
The current paradigm for analyzing clinical trial data is cumbersome it is an inefficient, slow, and expensive process. Several rounds of iterations between the main programmer and the validation programmer are usually needed to thoroughly explore …
In this workshop we will walk through an implementation of the R Validation Hub's white paper A Risk-based Approach for Assessing R Package Accuracy within a Validated Infrastructure (https//www.pharmar.org/white-paper/). The workshop will explore …
Shiny is a popular R package that lets users develop interactive web applications using just R code. The ease of use and downstream boost in productivity mean that working with Shiny can kick off a rapid request-implementation-inspiration-request …
For the Pharma Company How many times have you made a graph and gotten an email back saying "Can we change the axes?" or "Can we change the symbols?" or "I really need to look at the graph before I can tell you what I want". It would be much more …
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