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QC Workflow Optimisation – Started Q1 2025

The scope will include the following topicsProject Scope:

  • State of the union: how QC is broadly performed across the industry

  • What obstacles does double programming introduce when it comes to accelerating and making use of modern technology and techniques?

  • Alternatives to the current process

  • What impact does the adoption of Agile methodology have on the current QC process?

  • What are other regulated industries, such as banking and insurance, doing?

  • What is the cost of QC, and does changing the process impact on the cost positively or negatively?

How might the increasing use of AI change the QC process?

Current Status:

  • Project Approved

  • Project Calling For Volunteers

Regular Project Meeting Day/Time:

  • Kick-Off Meeting: TBC April 30 2025

Key Skills: (currently being reviewed by WG Leads)

Integration of Omics data into Clinical Drug Development – Calling For Volunteers Soon!

The scope will include the following topicsProject Scope:

  • Establishing best practices when working with BioCompute

  • A guide for creating and validating BioCompute Objects

  • Submission considerations for BioCompute Objects

  • Sharing of BioCompute Objects across the industry.

Current Status:

  • Project Approved

  • Project Soon To Be Calling For Volunteers

Regular Project Meeting Day/Time:

  • Kick-Off Meeting: TBC

Key Skills: (currently being reviewed by WG Leads)

The Use of Git in Statistical Programming – Q1 2025

Project Scope:

What features are most beneficial to stat programming? What are the benefits of Git?

There is interest across the pharmaceutical industry in using Git for statistical programming. Some companies have already incorporated Git, or are attempting to, and there are common challenges being faced. In these cases, the introduction of Git has increased the complexity of a statistical programmer’s tasks, which has led to challenges in uptake and to taking advantage of the benefits Git offers. This is an important challenge to overcome for increasing efficiency of operations. The purpose of this Working Group project is to provide the industry with tools and guidance for addressing and overcoming this common challenge.

Current Status:

  • Project Approved

  • Project Calling For Volunteers

Regular Project Meeting Day/Time:

  • Kick-Off Meeting: 4 April 2025

Key Skills: (currently being reviewed by WG Leads)