📃 The JSCDM Winter Issue is now available, capturing the momentum of what Ward Lemaire recently described as the “Golden Era of Data”, where we, as clinical data professionals, are not just keeping up with the change, but we're the driving force behind it.
This issue brings together research, perspectives, and updates that reflect the questions and innovations shaping our field:
➜ Patient‑centered trial design
➜ Ethical use of large language models
➜ Updates to foundational standards
➜ AI governance, real‑world data, and FAIR data practices
JSCDM continues to serve as both a scientific anchor and a catalyst for the knowledge our global community depends on. It is a foundation of SCDM Knowledge and our journey toward Vision 2030.
📖 Explore the Winter Issue and see where clinical data science is heading next: https://www.jscdm.org/issue/37/info/
Society for Clinical Data Management (SCDM)
Delen
Supporting clinical data managers and related professionals through education, professional developm
12/12/2025
Can Large Language Models really change the way we run clinical trials?
Administrative complexity has long been one of the biggest hurdles in clinical research. Slowing timelines, straining resources, and pulling focus away from what matters most: patients and science.
Our latest Digital First article, “Leveraging Large Language Models to Streamline Clinical Trial Data Administration: Balancing Efficiency with Ethical Responsibility”, explores how AI tools like ChatGPT could transform this reality.
Here’s what you’ll discover:
🔖 How LLMs can automate SOPs, documentation, and compliance workflows
🔖 Why efficiency gains must be balanced with ethical safeguards
🔖 Practical strategies for mitigating bias and ensuring responsible AI adoption
The takeaway? AI is a tool that, when applied thoughtfully, can make clinical research more agile, adaptive, and patient-focused.
📖 Read the full article on : https://www.jscdm.org/article/id/438/
24/11/2025
What does clinical data science look like in a year or two? What about in 2030?
At the 2025 Japan Conference, Ward Lemaire, Head of Data Management & Central Monitoring at Johnson & Johnson Innovative Medicine, and incoming SCDM Chair, will share where our industry is heading in the next five years and how will support this journey for clinical data professionals across the globe.
During his keynote, Ward will share a first glimpse into SCDM’s future-focused vision for 2030 which includes building partnerships and collaborations, transforming education, and expanding our global reach. All of this unified around one shared vision: to lead clinical data for a healthier world.
If you believe in a future where clinical data drives better health for all - our vision is your call to action.
📍 Join us at 2025 Japan Conference: https://scdmlive.org/japan-conference-2025/
19/11/2025
The SCDM 2026 EMEA Conference theme - Bridge Ideas, Build Futures - draws inspiration from Copenhagen’s iconic bridges, like the Øresund Bridge linking Denmark and Sweden. Just as bridges connect cities and communities, our work in clinical data connects systems, teams, and ultimately, patients.
This year, we’ll explore how stronger connections - between fragmented data sources, cross-functional teams, and the patient journey - can lead to smarter, more inclusive clinical trials.
Copenhagen is where we will meet for , where conversations will spark new ways of working, and collaboration turns into action.
Join us on 3-6 May 2026 to share your perspective, learn from others, and help build a more connected approach to clinical data: https://scdmlive.org/emea-conference-2026/
12/11/2025
AI-Powered Oversight Starts with Smarter Workflows
As Annexes 2 and 3 approach, clinical data teams must evolve from delegation to independent oversight.
During the next industry webinar brought to you by Revvity Signals, Christie Quarles, Philip Ross and Brent Meyers will explore how AI and automation are transforming how we detect risks, generate CtQ listings, and document decisions, without writing a single line of code.
If you’re navigating inspections, oversight, or AI-powered workflows, this session is your roadmap.🔗 Save your spot: https://register.gotowebinar.com/register/1721224331332138069
Oversight Isn’t Optional Anymore. Are You Inspection-Ready?
ICH E6(R3) is reshaping how sponsors approach oversight and inspectors are watching closely.
In this hands-on webinar from Revvity Signals, three experts - Christie Quarles, Brent Meyers, and Philip Ross - break down what’s already in effect (Principles + Annex 1) and preview what’s coming next.
💡 What you’ll learn:
Why “creator ≠ approver” is more than a compliance checkbox
How to apply risk-proportionate oversight using CtQ and RBQM
What ALCOA+ looks like when captured at the moment of decision
This is not just theory but a practical model that clinical data teams can apply immediately: Detect → Decide → Document
🔗 Register now to get the tools, templates, and governance tips you need to build audit-ready workflows: https://shorturl.at/BWtmm
Explore the and dimensions of biospecimen data governance in a new podcast episode.
In this sponsored episode, originally produced by Slope, Rust Felix CEO and Co-founder of Slope, sits down with legal and regulatory expert Edye Edens to unpack a critical — and often overlooked — aspect of the newly updated ICH E6(R3) GCP guidelines: biospecimen data.
💡 With EMA enforcement beginning July 23, 2025, this conversation is a must-listen for sponsors still relying on spreadsheets, paper, or disconnected systems to manage biospecimen workflows.
What you’ll learn:
☑️ Why biospecimen data now falls under ICH E6(R3) — and what that means for sponsors
☑️ Where hidden compliance risks live in your current workflows
☑️ What system validation really requires (and why misconceptions persist)
☑️ How to close gaps before EMA enforcement kicks in
Tune in to learn how to future-proof your biospecimen data strategy — and why governance is no longer optional.
🎧 Learn more and stream now➡️ https://scdm.org/scdm-sponsored-podcast-series-slope
We’re using AI to make clinical development smarter.
But are we smart about how we use AI?
That’s the question Munenori Takata will explore at — and it’s not just rhetorical.
Generative AI is already reshaping how we diagnose, analyze, and manage . But without clear governance, innovation risks outpacing responsibility.
Joining Munenori are Stephen Cameron, Mari Sugimoto, and Yasuhiro Yoshimaru who will walk us through what looks like in practice — and what it could look like tomorrow.
If you’re building, deploying, or regulating AI in , this session is your compass.
📍 Sept 27–30 | Baltimore
🔗 https://scdmlive.org/festival-of-opportunity-2025-program/
What happens in Baltimore shouldn’t stay in Baltimore.
That’s why we’re excited to have Veeva Systems as our Platinum Sponsor at — helping us capture and share the conversations that matter most.
From keynote insights to hallway debates, Veeva Systems is supporting the reporting that keeps our community connected — even if you’re following from afar.
Veeva’s Clinical Data platform enables a seamless and connected data flow across patients, sites, and sponsors — helping teams collaborate more effectively across the trial lifecycle.
As a Public Benefit Corporation, Veeva is committed to balancing the interests of customers, employees, shareholders, and the industry — serving over 1,000 life sciences organizations, from emerging biotechs to global leaders.
📍Join us in Baltimore, Sept 27–30
🔎 Learn more about Veeva’s Clinical Data platform: https://www.veeva.com/products/clinical-data-management/
29/08/2025
Still haven’t had a chance to dive into the Spring Issue of JSCDM?
This issue is packed with insights that reflect where we are, and where we’re heading as a profession. It’s grounded in SCDM’s 2030 Vision, with a clear focus on Clinical Research 2.0, End-to-End Data Flow, Intelligent Technologies, and Patient’s Choice.
Here’s what’s inside:
↳ A look at REDCapCloud.com
↳ Articles exploring AI, Machine Learning, and PowerBI®
↳ A newly revised GCDMP chapter: “Guidance for eCOA Development in Clinical Trials”
This issue also reflects on the latest initiatives—from the soft launch of our enhanced Learning Experience Platform (LXP), to new partnerships with MRCT Center, CDISC, PHUSE, and the FDA.
is your resource and a reflection of the work we’re doing together, and a reminder of the opportunities ahead.
📖 Read the issue: https://www.jscdm.org/issue/34/info/
Journal of the Society for Clinical Data Management | Issue: Issue: 2(5) Spring 2025 (2025) Joseph Geraci, Prasanna Rao, Cheryl Grandinetti, Bessi Qorri, Patrick Nadolny, Kassa Ayalew, Lisbeth Bregnhøj, Lindsay Edwards, Karen Hofmann, Sean Khozin, Nicolas Schaltenbrand, Torsten Stemmler, Alan Yeomans, Demetris Zambas and Ni Khin
What’s next for Clinical Data Science? You tell us.
Submit your session proposal for and share your outlook on the course of the CDM industry.
This year we're focusing on how tomorrow's trials will be shaped by:
✔️ How we connect fragmented data
✔️ Align cross-functional teams
✔️ Bring the patient journey into sharper focus.
Choose from one of the 7 CDM Competency Framework pillars - or submit a Wild Card idea that challenges conventional thinking.
If you’re ready to lead, inspire, and connect, we want to hear from you.
Submit your session proposal before 7 September and be part of the program 📝 https://scdmlive.org/emea-conference-2026/
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