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Open Source – Open Source in Pharma, Regulatory Acceptance and Validation

The Open Source Technology in Clinical Data Analysis (OSTCDA) project project was set up with the aim to create a manuscript on the integration of open-source software solutions for clinical data management, analysis and reporting.As well as the GitHub Discussion for the project, we are hosted this virtual Open Forum on 14 June to discuss this important topic in our Community.

Questions we addressed during this Webinar:

  • How do you establish reproducibility and traceability with open-source solutions, e.g. R package management?
  • How do you document your trust in an open-source solution to satisfy a third-party inquiry?

As well as the GitHub Discussion, we are hosting a series of forums throughout the year. See the Working Group Events page for further details. 



PresenterBio

Mike Smith, Pfizer

Mike has worked at Pfizer for 30 years and has seen enormous change both at Pfizer and across industry during that time. He trained as a statistician but now describes himself as a “professional geek”. The R Centre of Excellence at Pfizer is a little over a year old and it aims to build the R community internally at Pfizer, lead the way in demonstrating how to use R and other open source tools to build production grade deliverables and to provide expertise and consultancy to colleagues whatever their job role.