PHUSE

Registration is open for the Data Transparency Autumn Event 2024! Join us virtually across 17–19 September for access to insights from leading experts and to engage with cutting-edge discussions on data transparency. Find Out More: https://lnkd.in/eyjAWS4H Register Now: https://lnkd.in/efGPEh9c

Registration is officially open for the Data Transparency Autumn Event 2024! This highly-anticipated event takes place virtually from 17–19 September and is free to attend. With a dynamic lineup of speakers, presentations and Q&A in store, this is your chance to be at the forefront of data transparency advancements and contribute to shaping its direction. Topics range from cutting-edge approaches in autonomous security and transparent data sharing to the latest advancements in AI-driven data protection and clinical documentation. Discover the presentations and speakers on each event day: https://lnkd.in/eyjAWS4H and stay tuned for the full agenda later this month. Register Now: https://lnkd.in/efGPEh9c #PHUSE

PHUSE are delighted to shine a spotlight on the dedicated individuals who make the PHUSE Blog an engaging and informative resource. Working diligently behind the scenes, each of our Blog team members brings unique expertise and perspective to ensure our blog covers topics relevant to the PHUSE Community. Want to get involved? Become an industry guest blog writer! Share your unique insights or in-depth analysis on current trends with our global audience. Email [email protected] to learn more and express your interest. Read Our Blogs: https://lnkd.in/e9gMiFtR #PHUSE

PHUSE, CDISC and the FDA collaborated to execute a pilot from September 2023 to April 2024 to test the feasibility of using CDISC Dataset-JSON as a transport format for study data submitted with regulatory applications. The pilot aimed to demonstrate that CDISC Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. This webinar presented the findings of the pilot and next steps as published in the PHUSE white paper (https://lnkd.in/e8ct_eVa). Watch Now: https://lnkd.in/drPp4YSg #PHUSE | Chris Price, Sam Hume, Jesse P. Anderson

Could you be the EU Connect 2024's Connect Monday Dinner sponsor? As we gear up for the highly anticipated event in Strasbourg, France, 10–13 November, sponsorship opportunities are quickly approaching sell-out! Don't miss the chance to make your mark on this event and sponsor one of the most exciting and well-loved evenings at the conference. By doing so, your company will gain prominent visibility, build meaningful relationships and leave a lasting impression. Find full details in the prospectus: https://lnkd.in/e5aqNd_N Get in touch with [email protected] to secure this package now for €9,500. #PHUSE | Anne-Sophie Bekx, Jennie McGuirk, Jinesh Patel

As we approach the end of 2024, don’t miss your chance to be part of PHUSE's insightful SDEs. With just 12 SDEs remaining this year, there are plenty of opportunities to get involved, whether you want to attend, speak or both! Open for registration: ↳ Collegeville (PA), United States | 29 August Theme: Navigating the Path to Regulatory Success: Streamlining Data Processes for Effective Submissions View Agenda & Register Now: https://lnkd.in/erQ48faQ ↳ Mississauga (ON), Canada | 13 September Theme: Coding the Future: Tomorrow’s Statistical Programming Toolset View Agenda & Register Now: https://lnkd.in/gZ5k7xpv ↳ Basel, Switzerland | 18 September Theme: Open Horizons: A Symphony of Capabilities View Agenda & Register Now: https://lnkd.in/eBDkuV7g Don’t miss the pre-SDE workshop the day before! Calling for speakers:   ↳ Ridgefield (CT), United States | 21 October Theme: Value Creation Using Real-World Data Submit Your Abstract: https://lnkd.in/e5_33cGc (deadline 16 August) ↳ Cary (NC), United States | 21 November Theme: AI in Clinical Research Submit Your Abstract: https://lnkd.in/e4G7N66N (deadline 30 August) View all remaining SDEs: https://lnkd.in/e3ATjNB6 Don’t let these opportunities slip by! #PHUSE

Keep your eyes peeled for this graphic over the coming weeks! The US Connect 2025’s Stream Chairs will be sharing this graphic alongside their tips and insights into their Stream, as well as their topic inspiration for Call for Paper submissions… Submit your 150-word abstract to one of the Connect Streams by 6 September – don't miss this opportunity to share your knowledge and advance the future of innovations. Register Now: https://lnkd.in/e4zDgs5W Submit Abstract: https://lnkd.in/eiv9WP24 Find out More: https://lnkd.in/eGuEmFg9 #PHUSE | Karnika Mahat Dalal, Kirsty Lauderdale, Harper Forbes, George Stuts

The America's SDE in Radnor (PA) took place last Thursday, and it was a huge hit! 55 attendees came together in Pinnacle 21 by Certara’s new office to explore the theme of ‘Back to the Future of Clinical Trials: Navigating the Ever-Changing Landscape When Conducting Clinical Research.’ The presentations and dedicated networking sessions sparked insightful discussions on the future of clinical trials. From innovative approaches to data management to strategies for navigating regulatory landscapes, so much valuable information was shared. Presentations are now available to view: https://lnkd.in/eXquBX3j  #PHUSE

The Real World Evidence Working Group is back with another insightful blog post! In our latest publication, we dive into the FDA's guidance on using registry data to support regulatory decision-making. This blog, crafted by the Quality and Reusability of Real World Data project, examines key topics from the guidance and highlights the challenges we face in current practices. Take a look at the blog post titled "RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making" Read now: https://lnkd.in/eGjdUUqT Project Information: https://lnkd.in/erm6fmbG #PHUSE | Chris Price, Berber Snoeijer, Ashwin Rai, Parag Shiralkar

Submit your abstract to present at the incredible US Connect 2025 in sunny Orlando, Florida, from 16–19 March. Last year, we received a record-breaking number of submissions for the US Connect event, so let's make history again! In need of inspiration to write your abstract? PHUSE has got you covered! ↳ Explore the diverse Connect Streams: https://lnkd.in/gyMhsHEJ If you’re unsure if your topic fits within one of these Connect Streams, please submit your abstract to the Non Specific Stream. ↳ Gain direct insights from some of our Stream Chairs! Analytics and Statistics (AS) Jing Dai:  https://lnkd.in/eBmguKw3 Machine Learning, AI & Large Language Models (ML) Caroline Phares: https://lnkd.in/exxNAnBs Don't miss out on this incredible opportunity to share your research and network with professionals from around the globe. Call for Papers closes on 6 September. Submit your abstract today! Find Out More: https://lnkd.in/eGuEmFg9  Submit Abstract: https://lnkd.in/e3vj-nRy #PHUSE