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The PHUSE Working Groups, which are led by volunteers from major stakeholders, have been developing innovative solutions that address unmet computational science needs. Here, we will look to share the latest information around the PHUSE Working Groups, from workshops to White Papers, project news and Industry views.



Working Groups End of Year blogOver the course of the year, the PHUSE Working Groups have published 28 deliverables and concluded 12 projects. Read our latest blog to find out all they have achieved in 2020.
Working Groups Latest ReportThis Report provides a detailed overview of the projects progress to date.
Pistoia Alliance Webinar on Informed Consent Blockchain

Wednesday 27th January 17:00 - 18:00 CET

Register here.

Synopsis and Session Objectives:

Patient control of personal data and regulatory compliance are key areas of improvement in clinical trials. Blockchain technology can help address these by bringing an unprecedented level of security and trust to the way information is exchanged and recorded between parties during a clinical trial.

In this webinar we will present our work in the context of a multi-pharma project led by Pistoia Alliance to implement blockchain technology in the Clinical Trial Informed Consent process. We will deep dive into how the technology can streamline patient participation in clinical trials and increase the speed and compliance of clinical trials by ensuring greater control over the Informed Consent process as well as ‘anytime’, real-time auditing.

Speaker Bio:

Dr. Michael Rüther is CFO/COO and co-founder of Spherity. Prior to founding Spherity, Michael founded two ventures in the IT and innovation space and worked in management positions for RWE, SMS Demag, ThyssenKrupp and Fraunhofer institute. Michael has a cross-industry technology background and holds a PhD in Business Computing of the Heinz Nixdorf institute.

Projects Calling for Participants 

Project Idea?

Our Nonclinical Topics Working Group is currently looking for a Co-Lead. If this is a role you are interested in supporting, click this link to find out more and submit your application.

The Industry SEND Progress Survey project in the Nonclinical Topics group is seeking new team members and/or co-lead to develop a new direction and future scope. Click here for more information. 


The Harmonization of SEND Implementation to Enable Historical Control Data Analysis are collaborating with BioCelerate to find solutions to overcome cross-study analysis challenges highlighted in the last CSS meeting. One of the issues identified was determining which studies used a specific vehicle component. To help find a solution results in the greatest value for the least pain for everyone, the team has prepared datasets following 3 different possible approaches and are asking for your evaluation of them. Between now and January 15, 2021, please allocate about 5 to 10 hours to evaluate these approaches and inform us of the results by completing this survey. This short timeline for evaluation is necessary to enable CDISC to consider the outcome of this work as they finalise the scope for the next version of SEND. Instructions and the survey are available here.


Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must 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 least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here for template and submission.

Webinars Events 

Have you attended a PHUSE Webinar Wednesday?

They run throughout the year around the last Wednesday of every month and include presentations of hot topics in the industry and PHUSE.

Click here to register and view previous presentations. 

Our PHUSE events are different in both nature and set-up. PHUSE events started back in 2004 with the inaugural PHUSE conference in Heidelberg. Since then PHUSE has been organising events all over the globe. With that, we strive to meet the needs of our global membership to share, advance and connect. All our events are aimed at different audiences. Click the banner above to see upcoming events. 


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