Call for Project Volunteers 

The PHUSE Collaboration is accepting proposals for new projects. A proposal will address problems of significant relevance to computational science related to drug, biologic and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements: 

  • The projects must address significant research issues relevant to computational science
  • The project must not attempt to address FDA policy issues
  • There must be at one Project Lead personally involved in planning and carrying out the project

New Projects can be submitted anytime during the year

Projects of Particular Interest to the Collaboration include:

  • List and prioritisation of issues in drug, biologic and device development related to computational science
  • Identification of possible projects based on pressing issues in drug, biologic and device development related to computational science
  • Identification, prioritisation and potential pilots of emerging tools and technologies
  • Projects that fall within the scope of existing defined Working Groups

Application Process

Complete a New Project Request

Completed forms should be sent as an email attachment to workinggroups@phuse.eu

 

 

 

Working Group & Project Lead

Project Title

Description

Data Transparency 

Lukasz Kniola and Sarah Hewitt

Terminology Harmonisation

Currently there is inconsistency in terminology used in the field of data sharing and disclosure. These inconsistencies exist across industry and regulatory agencies as well as within PHUSE and cause unnecessary confusion. This project aims to collect, align and standardise terminology and their definitions used in to be used in future PHUSE deliverables. Previous PHUSE deliverables as well as key publications in the field will be examined to create a proposal for a baseline list of terms and definitions to be used moving forward.

Nonclinical 

Kevin Snyder and Mark Carfagna 

Harmonization of SEND Implementation to Enable Historical Control Data Analysis

The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research.

 

 

Thinking of joining PHUSE?

Already a member but not sure how you can benefit?

PHUSE is an expanding, global society with a global membership of clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

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