Biopharmaceutical Software Working Group

Welcome to the home page of the Biopharmaceutical software working group (BiopharmSoft).

BiopharmSoft was created in August 2018 to initiate a community-led effort aimed at building and validating software tools for biopharmaceutical applications.  The initial suite of tools envisioned for development will include open-source software, including R-based software and free Windows-based software packages with a graphical user interface. These software tools will support novel simulation-based approaches, including Bayesian approaches, to the design and analysis of early-stage and late-stage clinical trials. In addition, the working group will actively reach out to other groups across the biopharmaceutical industry to discuss and set up collaborations that would facilitate the development of free software aimed at biopharmaceutical applications.

The working group’s goals include

·       Identify the gaps in the availability of software tools that facilitate the design, conduct and analysis of clinical trials with emphasis on tools that enable efficient clinical trial simulation.

·       Develop best practices for clinical trials simulation.

·       Develop general guidelines and more detailed specifications for statistical software tools, including software testing/validation guidelines.

·       Identify and collaborate with software developers to build free statistical software tools based on the specifications created by the working group.

·       Create a network of reviewers for testing the statistical software tools designed by the working group and gathering feedback to inform the next steps of the software development process.

·       Develop documentation and other instructional materials, including free training videos on BIOP’s YouTube channel, for the software tools.

·       Prepare publications, organize conference presentations and develop training courses to introduce the software tools designed by the working group to the biostatistical and clinical trial communities.

The goals are expected to be reviewed and revised on a regular basis.

Information on the BiopharmSoft’s work, its detailed plans, list of deliverables as well as general updates are available on the working group’s web page: