We look forward to welcoming you in person at the US Connect 2022, 1–4 May in Atlanta, GA. Expect ground-breaking content from across 18 Streams, immersive Hands-on Workshops, our three inspiring Keynote Speakers Hal Stern, Ricky Kalmon and Matthew Richey and a half-day CDISC Partner Event!

If you aspire to gain exposure to cutting-edge problem-solving across the selected Challenge themes, then our PHUSE/FDA Innovation Challenge is for you. Read the full schedule in the agenda below.

More than 450 global attendees are already registered. Secure your place at what will be a truly unmissable event experience.

It’s not too late to reach and connect with your relevant audience through our sponsorship and exhibition packages. Contact the events team for more information.

Join us in person at the EU Connect 2022 taking place at the ICC in Belfast, UK, 13–16 November. Save the date – registration and hotel booking opens 9 May.

Call for Papers is open! Visit the PHUSE website and get your ideas flowing by viewing the Connect Stream descriptions. Find out more about the submission process and simply submit your 150-word abstract by 13 May. Still undecided? Check out the PHUSE Blog for reasons to present.

Sponsorship packages and branding options are now available. View the prospectus and if you have any enquires please contact events@phuse.global.

The first Single Day Event of 2022 was the India Spring SDE held last month, on the theme of Application of Open-source Technologies in Data Sciences and Analytics.

This event was a great success, with over 300 individuals attending live. Recordings and presentations are now on the PHUSE Engagement Hub.

“I liked everything about this SDE. I came to know about Julia open source for the first time and am interested in learning it. Getting to know and learn new things is what made this event so worthwhile” – India Spring SDE attendee.

Upcoming Single Day Events:

• India Summer SDE – 11 June
  

• EMEA Summer SDE – 21 June
  

Keep an eye on the PHUSE website for information due to be released soon. Sponsorship and branding options are available, take a look at the prospectus for further details.

Save the date! We look forward to welcoming you at the Data Transparency Summer Event, 28–30 June 2022. This will be held virtually over three days and is free to attend.

Presenters will share their experience and insights around the ongoing needs of data transparency within the clinical development arena, followed by a panel discussion and Q&A session.

We saw hundreds of individuals join us live for the Winter Event. If you missed it, you can catch up on the recording via the PHUSE Engagement Hub or read the summary blog.

PHUSE offer a variety of sponsorship packages. Find out more in the prospectus.

This month’s Webinar Wednesday is host to an exciting line-up of topics! Secure your spot now on this free webinar, which is open to all, on 27 April at 15:00 (BST).

Agenda:

• EU Connect – Registration Opening Soon!
• Single Day Event: Hot Topic on the Application of Open-source Technologies in Data Science and Analytics
• Safety Analytics Working Group: Investigator Assessment of Causality – Opportunity for Simplification?

Take a look at the Working Group’s recent blog to find out more ahead of the webinar.

Catch up on the March PHUSE/CDISC webinar, for an insight into the partnership, joint projects and upcoming collaborations including a Partner Event at the US Connect in May. This webinar and previous events are available on the PHUSE Engagement Hub

Deliverables Calling for Feedback 

As part of the Optimizing the Use of Data Standards Working Group, the Clinical Integrated Study Data Reviewers Guide project has prepared a final draft version of the iADRG.

The guide provides regulatory reviewers with additional context for integrated analysis datasets received as part of a regulatory submission. The iADRG is intended to describe analysis data submitted for integrated data summaries (ISS, ISE, etc.).

The team is calling for public feedback by 13 April on the iADRG which includes a template, completion guidelines and examples. Please send to workinggroups@phuse.global using the iADRG feedback tracker to log your comments.

• iADRG Template
• iADRG Completion Guidelines
• iADRG Example 1
• iADRG Example 2 with LDPC

SDTM FAQ IND/Multiple Screenings Response 

The SDTM ADaM Implementation FAQ project, under the Optimizing the Use of Data Standards Working Group, has published two new responses to questions they received under Data Submission.

The questions are based on the submission of subject information with multiple screenings to the FDA, as well as submitting clinical trial data at the time of submitting an IND. If you are curious to know more, visit the PHUSE Advance Hub.

Call for Volunteers – Working Group Leads

Emerging Trends & Technologies – 2 Working Group Leads

Data Visualisation & Open Source Technology – Working Group Lead

If you are interested in becoming a Working Group Lead, please provide a brief summary of how you feel you can contribute to driving the Working Group forward. Please send your application to PHUSE Working Groups Director, Chris Price, at chris.price@phuse.global by Friday 12 April.

Executive Summary Report  

View the latest PHUSE Working Groups report published March 2022. 

Advance your own development and that of your colleagues! Supporter benefits range from event discounts to free job advertising on our website. Have you renewed your package for this year? Or would you like to become a PHUSE Supporter? Contact community@phuse.global.

A huge thank you to the 33 companies below who have already signed up this year to support us in continuing our mission to advance the future of life sciences.

Are you suffering from knowledge or workforce gaps? Growing your teams? Transitioning to R? It may be time to bring in a specialist: Experis. We have solutions to get you on the fast track, including an easier way to transition from SAS^® to R with our Accel2R programme.

Let’s chat at the PHUSE US Connect! Email Steve.Walker@experis.com for a live demo.