Updates from the Board – Q2 2024 (2024)

Dear SCDM Friends,

SCDM has delivered on its promises for the first quarter of 2024. There have been significant content releases includingJSCDM’s Spring issuefocusing on clinical data science and informatics and the launch of ournew website and branding. There is continuing momentum on the SCDM Industry Competency Framework to map content to our learning journeys and four SCDM Essentials workstreams; SCDM Knowledge, SCDM Community, SCDM Certification and SCDM Live. The release ofCDS 101, hosted by Patrick Nadolny (Sanofi’s Global Head of Clinical Data Management and SCDM Chair), is also a significant milestone and an hour of complementary SCDM training you definitely will not regret! The conferences this year are in full swing with our largest ever SCDM EMEA conference setting our benchmark of informative content, leadership, networking, regulatory insights and an outstanding high-octane keynote speaker. We wrapped the EMEA conference with a board meeting setting the stage for the accomplishments yet to come throughout the year.

Board of Trustees meeting updates

Our global Board of Trustee’s meeting on 19 April was a quick one, but highlighted work on our CCDA certification and supporting materials. It was noted that we are actively seeking webinar speakers for slots throughout the year. If you are interested in being a webinar speaker, please reach out to our SCDM education committee. We also discussed the EMEA conference and preparation for the many conferences yet to come this year.

EMEA conference (17-19th April 2024)

The EMEA conference was a resounding success with well over 300 attendees spanning 27 countries. As we grew substantially, the venue changed this year to a hybrid format where the leadership and pre-conference sessions were hosted at Merck Research Labs. Thank you, Christopher Lamplugh (Head of Global Data Management & Standards, Merck Research Labs) and the MRL team, for an excellent location to collaborate and learn. The main event was at the Sofitel Victoria Hotel, allowing for an elevated vendor hall and keynote experience. There were many takeaways from the leadership session and, if you can believe, only one was around AI! A couple to highlight is to continue to ground yourself by thinking about the site and patient experience, considering whether you are making that journey easier and change for an individual often starts with a reaction of fear. To temper that fear, consider as a part of your future vision what that individual’s role will play in the framework and emphasize that they are a part of it! Our regulators also shared some valuable insights including the importance of data flow diagrams in your Data Management Plan and the potential safety ramifications of not catching a dose tapering programming error. Also, there were 7000 comments received for the ICH E6 R3 draft! If you haven’t had a chance to take a read through, now’s a good time.

For the conference itself the core learning focus of the event wascross-collaborationandits ability to drive innovation in Clinical Data Science, brought to life by the co-chairs Paulina Szczepaniak (Director of Operations, Clinical Data Management, MSD), Joanna Florek-Marwitz (Head Risk Management & Data Quality, UCB), and Irina Sher (Vice President, Data Management at Bioforum). We kicked off with a keynote from Paddy Lowe, CEO of Zero Petroleum and former Technical Chief Engineer of FI teams Williams, Mercedes as well as Technical Executive Director of McLaren. Paddy shared insights of the parallels with the stakes of F1 and data science, including that new data can inspire new innovations. Beyond the data, Paddy reminded the audience, through a terrific analogy of the 2016 Brazilian rain race where all data pointed to the rain tapering off but the puddle beside him told a different story and critical thinking allowed him to make the right call at the right time! Tanya DuPlessis (SCDM BoT member and Chief Data Strategist and Solutions Officer at Bioforum) and Christopher Lamplugh joined him on the stage for further discussions including the connection to the five V’s with a highlight to consider data stakeholder uses may vary and to focus on the data that matters for the targeted use.

After the keynote, the conference expanded into three streams with dozens of speakers, including Jonathan Andrus (President & COO, CRIO and SCDM Executive Treasurer) hosting our regulatory panel including Dr. Kassa Ayalew (Division Director, Division of Clinical Compliance Evaluation, US FDA), Dr. Cheryl Grandinetti (Clinical Pharmacologist, US FDA), Dr. Lisbeth Brenghøj(GCP Inspector DMA) and Mandy Budwal-Jagait (GCP Inspector, MHRA). There were many takeaways, including a focus on the ICH E6 (R3) key foundational principles that support risk proportionality and inspection finding examples. If you missed a session, don’t worry, attendees will be able to watch recordings in the coming weeks. For me, mutual mentorship was a takeaway concept wherein young employees can also mentor their managers on the technologies and learning strategies they deploy as they can differ greatly from more “seasoned” employees – my hair seasoning happens to be more of the salt and pepper variety these days it seems!

Many thanks to Wayne Walker and Medidata for hosting an extravagant social event full of dancing and networking before our last day and closing plenary led by Richard Young (Veeva) on what you would like to have disappear in George Orwell’s 1984 room 101 or magically appear. There were some fun ones like Excel and sponsors to disappear. To appear magically; all systems to connect automatically as well as a machine to read minds and instantly creates the needed tools. For me, I am going big and putting disease into room 101 and site to site teleportation to appear magically as an open-access technology. If you thought this year’s EMEA was amazing, you won’t want to miss next year, hosted by Ward Lemaire (Head of DM, Janssen R&D, SCDM BoT member) and J&J in Brussels, Belgium!

Annual Conference 2024 (September 29 – October 2)

The session chairs have all been identified and are reviewing 200 outstanding abstracts received to select best-in-class speakers for their sessions in May. This year’s theme is a Festival of Opportunities. Packed with potential, this year’s conference will reveal new ideas, powerful new technology, world-class guest speakers and key presentations on topics ranging from Clinical Data Science (CDS) & Analytics to AI & cognitive tech including eight topic streams to choose from and a special event yet to be announced. Join us in the heart of Boston, Massachusetts 29SEP-2OCT. Registrations are now open!

China

SCDM’s seventh China conference is fast-approaching and will occur June 27-29, 2024 in Shanghai and a theme of “Focus Data Science, Foster Transformation”. The focus is on the shift from CDM to CDS and will include hot topics such as regulations and standards, risk-based quality management (RBQM), DCT, AI and other new technologies in clinical data management as well as real-world data curation. The pre-conference workshops on the 27^thwill focus on quality in clinical data management to meet regulatory requirements and new technologies in clinical data management.

India

The single event on June 29, 2024 in Ahmedabad is themed on the RBDM Odyssey – From Foundation to Practice. Registration is open!

We are well on the way to the formal launch of the CCDA certification in 2024 including supporting study materials and CDA 101. If you are new to Clinical Data Management (0-2 years) and interested in signing up for the beta exam, you can sign up here:https://app.prolydian.com/organizations/scdm. If you are looking for content on Clinical Data Science,CDS 101is the first step towards continued development of CCDS, For those looking to register for your CCDM, here is aquick linkto get you there. TheCDM Industry Competency Frameworkis highlighted in the CDS 101 training and overlays key focus areas for CDA, CDM and CDS. Lastly, if you like listening to something on your walks, commutes or while washing the dishes, you may enjoy listening to one of our growing library of podcasts! Check them outhere.

Secretary, SCDM Board of Trustees

You know you want to, and what better way to connect with SCDM’s community of experts and share and grow your knowledge. Pick from one of our four strategic pillars around education, content alignment, community engagement and global expansion. If you want to learn more, pleaseclick to find out more!

Thank you!

I hope you have enjoyed the updates shared and look forward to connecting with you throughout the year, sharing insights, highlights and a bit of fun along the way! Cheers, Stephen.

Stephen Cameron

Secretary, SCDM Board of Trustees