CDISC

Don't miss your chance to register for the 2024 Korea Interchange! This event is the region's premier opportunity to connect with industry leaders, hear CDISC standards success stories, and learn about CDISC's roadmap for the future. Join experts for insightful discussions, interactive sessions, and invaluable networking opportunities. https://lnkd.in/gnjdBW2q

Congratulations to our first cohort of participants who completed "The Critical Role of Data Managers, Biostatisticians, and Programmers in Achieving TMF Excellence" training at the CDISC US + TMF Interchange in Scottsdale! Thanks to our expert trainers, Lisa Dotterweich Mulcahy and Dawn Niccum, this dedicated group has gained valuable insights into the critical impact that Data Management, Biostatistics, and Clinical Programming have on the Trial Master File (TMF) and its regulatory significance. Through focused sessions on TMF management principles and the CDISC TMF Reference Model (Zones 10 and 11), participants explored the essential processes and standards that empower them to support clinical study data with excellence and rigor. We're excited to see how these professionals will apply their enhanced skills to achieve stronger compliance and optimize TMF management within their organizations. Well done to everyone for your commitment to quality and compliance in clinical trials! If you missed the Training at the Interchange, the next opportunity is virtual in January 2025! Enroll here: https://lnkd.in/e8-7V64R

Join CDISC's Chris Decker and additional industry partners for PHUSE's Webinar Wednesday on 30 October at 15:00 GMT! Register here: https://lnkd.in/eVEQGcJ6 #cleardataclearimpact

We are thrilled to announce the release of a collaborative white paper with the Japanese Collaborative Committee for Clinical Informatization in Diabetes Mellitus (CCCIDM): Linking the Collaborative Committee for Clinical Informatization in Diabetes Mellitus (CCCIDM) with Data Standards in Diabetes Care. A huge thank you to our partners at CCCIDM for their invaluable expertise and dedication. Together, we’ve developed a resource that advances the adoption of data standards in diabetes research, enhancing data interoperability and supporting better patient outcomes. Read the full white paper to learn more about our joint efforts to drive innovation in diabetes informatics: Link to white paper: https://lnkd.in/ecws7vyf #diabetesresearch #cleardataclearimpact

A huge thank you to everyone who helped make the 2024 CDISC + TMF US Interchange such a success! From our insightful attendees and expert presenters to dedicated exhibitors and generous sponsors, your engagement and support were instrumental in driving the event forward. Highlights included compelling presentations on CDISC Foundational Standards, Digital Protocol Implementation, and AI & Automation in Clinical Data Management. Sessions on Data Governance, ICH M11 Protocol Development, and End-to-End Standards brought fresh perspectives and practical solutions, inspiring us all to push for new levels of innovation and collaboration. The dynamic discussions, networking, and exhibitions demonstrated our shared commitment to advancing data standards in clinical research. Thank you for being part of this journey with us! #cdisc2024us #cleardataclearimpact

So as the sun sets on another CDISC interchange and the inevitable trip to an airport, you start to reflect on all the presentations attended, posters read and conversations from a packed three days. Unusually, rather than the usual mess of tangled thoughts one clear message is in my head. We turned a corner, we have reached the top of a climb, we reached a tipping point. If I had 1$ for every mention of ICH M11, USDM or digital protocol, I would be a very happy man. From keynote through FDA talks to industry panels there was a single strong message, the digital protocol has arrived. There is still a long road to be travelled but I would like to thank the CDISC team who diligently develop the standard, CDISC for supporting it, TransCelerate BioPharma Inc. for funding it, our SMEs helping us on the journey and the sponsors and vendors adopting it. The next few months are going to be fun.

Insighful perspectives on Activity Concepts in OpenStudyBuilder from Novo Nordisk’s Mikkel Traun as part of a panel discussion on Biomedical Concepts in Practice at CDISC US Interchange. Feels like we’re making real progress in this space as an industry. A very illuminating discussion from all panellists. #cdisc #openstudybuilder #biomedicalconcepts #activityconcepts #cdiscusinterchange

Day 2 of the CDISC + TMF US Interchange in Scottsdale featured an insightful session led by Chris Decker, Sam Hume, and Peter Van Reusel, focusing on advancing the CDISC 360 initiative from proof of concept to full implementation. The next phase, now branded as 360i (with "i" for Implementation), aims to streamline key processes across three critical areas: • Defining End-to-End Standards • Automating Study Design and Build • Automating and Streamlining Data Flow The discussion was further enriched by a panel of Board Members, including Brooke Hinkson, Jonathan Chainey, and Rhona O'Donnell, who explored the next steps and opportunities for driving the initiative forward. By enabling automation and reducing variability, 360i is set to foster greater interoperability and efficiency across the clinical research landscape. If you are attending live in Scottsdale and missed the chance to provide feedback via the QR code, please visit the CDISC booth to participate in the survey! #cdisc2024us #cleardataclearimpact

A heartfelt thank you to all attendees, presenters, session leaders, sponsors, and exhibitors for your participation and engagement! Day 1 of the CDISC + TMF US Interchange was a tremendous success. The insightful presentations provided not only valuable information but also inspiration, offering perspectives that will help shape the future of our industry. The dynamic discussions, networking opportunities, and exchange of ideas fostered a spirit of collaboration and innovation, truly capturing the essence of the CDISC + TMF US Interchange. More to come tomorrow with Day 2! #cdisc2024us #cleardataclearimpact