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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.

Deliverables 

Q42020 Published Deliverables 

Calling for Feedback 

The Safety Analytics Working Group held a Workshop at CSS based on Planning and Interpreting Safety Analyses for Integrated Summaries. Click here to view the recording and here for the slides.

The CDISC Implementation Primer project has put together a series of short, animated videos as well as helpful links to introduce newcomers to the suite of CDISC Standards. Click here to read the standards. 

NOW LIVE! Take a look at our recently published update on COVID-19's Impact on CTT. This gives update to some of the initiatives that have changed since the initial discussion on the 'Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project'. Read more here.

There are no deliverables currently on review.


Volunteers 

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.

As a volunteer-led community, volunteers are at the heart of everything we do. Our success is drawing on the knowledge and experience of our supporters and in return we aim to provide a neutral platform for creating and sharing ideas, implementing data standards and exploring innovative methodologies and technologies.

Click here to see the latest volunteering opportunities. 


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.

We greatly appreciate your help in forming our future together, even if you are only able to respond to some of the questions.

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.

General

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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