Statistical Computing Environments

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Project Title

Statistical Computing Environments (SCEs)

Project Team Members

Project Lead: Art Collins

Project Co-leads: Stephen Matteson, Olivier Leconte, Mark Matthews

Affected Stakeholders

Could include statisticians, clinical reviewers, nonclinical reviewers, software developers, SDO, etc.

Definition(s) of Problem/Issue/Challenge

This project came about because of a common set of challenges facing organizations across the industry around Statistical Computing Environments (SCEs). The group has four objectives:

  1. Discuss the current state of SCEs, identify common gaps and share best practices
  2. Define ideal case user requirements for an SCE
  3. Clarify expectations for an SCE within industry and regulatory agencies regarding implementation and compliance
  4. Explore SCE relationship to the Metadata Repository (MDR) and the Clinical Data Repository (CDR)

Related Pages

Deliverables and Dates:

Deliverable Date
Follow-up meeting 29 April, 2015
Round-table discussion at PharmaSUG May, 2015
Draft white paper titled ‘The State of the SCE’ by October, 2015
Discussion club/round-table discussion at PhUSE Annual Conference October, 2015
Publish white paper on the State of the SCE by end of year December, 2015
Begin working on white paper defining user requirements for optimal SCE March, 2016



Last revision by Collinsa,04/17/2015