Dear SCDM Friends,

The last quarter has been full of activity for our SCDM community.  We had both our South Africa Single Day Event and our Annual Conference.  We launched our CCDS Beta Exam and our elev8 learning experience platform. On the publication front, the fall edition of JSCDM is released and a new chapter of GCDMP on Risk-Based Quality Management was circulated for public review! Looking to next year, the Board elections were announced. 

Conference updates

The SCDM 2025 South Africa Single Day Event, held on August 22 in Bloemfontein, brought together clinical data management professionals from across the region and beyond for a day of focused learning, networking, and innovation. Under the theme “Data Management 2030: Embracing Innovation and Advancing Our Future,”, the event explored the evolving landscape of Clinical Data Science, emphasizing the importance of forward-thinking strategies and technological integration. The program was designed to foster meaningful dialogue and collaboration, with sessions that addressed both current challenges and future opportunities in the field.  Before getting started, there was a pre-conference SCDM academic outreach at the University of the Free State, with dozens of students in attendance, eager to learn about clinical data management careers. 

The agenda featured a dynamic mix of keynote addresses, panel discussions, and interactive sessions. Highlights included a keynote from Nomsa Mtshali (Rare Diseases South Africa), reflecting on the current state of data management.  A terrific quote from her was  

Data makes a difference every day, and as custodians of that data we are directly making a difference every day!

There was also a panel on the implications of ICH E6 (R3) for clinical data professionals, and presentations showcasing practical solutions to common industry issues. Attendees also engaged in roundtable discussions on statistical topics and regulatory technologies, reinforcing the event’s commitment to both strategic insight and operational excellence. The day concluded with a closing ceremony and final networking session, leaving participants energized and inspired. 

This single-day conference exemplified SCDM’s mission to connect and empower the global clinical data community. By spotlighting innovation and fostering regional engagement, the South Africa event served as a catalyst for professional growth and industry advancement. With strong participation and impactful content, the 2025 edition built on the success of previous years and set the stage for continued collaboration and progress in clinical data management across Africa and beyond. 

The agenda featured a dynamic mix of keynote addresses, panel discussions, and interactive sessions. Highlights included a keynote from Nomsa Mtshali (Rare Diseases South Africa), reflecting on the current state of data management.  A terrific quote from her was  

Key takeaway from the event:  

• Future-Focused Data Management: The conference emphasized the importance of preparing for the future of clinical data science, particularly in light of evolving global standards and technologies. The theme “Data Management 2030” encouraged attendees to think strategically about innovation, automation, and the integration of AI and machine learning into data workflows. 

• Regulatory Readiness and ICH E6 (R3): A major focus was on the anticipated changes in the ICH E6 (R3) guidelines and their implications for clinical data professionals. Experts discussed how these updates will affect data integrity, risk-based approaches, and the role of data managers in ensuring compliance and quality. 

• Regional Collaboration and Capacity Building: The event highlighted the growing importance of regional engagement in Africa, showcasing local expertise and fostering connections among professionals. Discussions underscored the need for continued investment in training, infrastructure, and partnerships to support the continent’s expanding role in global clinical research. 

Our SCDM 2025 Annual Conference, themed “Hey Data, Where To Next?”, took place from September 27–30, 2025, in Baltimore, Maryland, at the Baltimore Convention Center. Our flagship Festival of Opportunity event brought together global leaders in Clinical Data Management to explore the future of data-driven innovation. 

Before our conference got started, SCDM’s Board met to discuss active deliveries, accomplishments and our 2030 roadmap.  We also spent a half day at the University of Maryland Health Sciences and Human Services Library, where we met with students and alumni to discuss career journeys in clinical data science.  Dean Emily Hurst, MSLS, and staff were exceptional hosts and provided a wonderful setting for learning and sharing.  Did you know that librarians spend a large portion of their time doing research, not just filing books?  A special thanks to Dr. Eun Shim Nahm, Professor and Associate Dean, PhD Program, UMD School of Nursing, for sharing her personal journey and insights in interactions with clinical trial data.  It paired well with our discussions as we observed parallels within the practice of nursing informatics and sparked interest in our next generation of clinical data professionals.  

Following the Academic Event, we joined other thought leaders at the Industry Summit, where we expanded the conversation on AI impacts to our clinical trial industry.  Discussions included not only regarding the deployment and regulatory considerations but also on the personal impact to our workforce.  A couple key thoughts are that the transformative nature of AI is not a substitute for human expertise, but that it is a catalyst.  Humans will remain vital to clinical trial delivery as their roles evolve synergistically with AI augmentations.  As with our delivered commitment to our EMEA Conference, we are working to summarize these insights in a future paper for our SCDM community.  If you haven’t read the EMEA perspective on the future of clinical trials with AI and DCT, hybrid and data-driven approaches, you may want to check it out! 

We then proceeded to pre-conference workshops covering topics such as AI/ML, regulatory updates, and soft skills in clinical data science, offering deep dives into practical applications and emerging trends. The Leadership Forum provided senior professionals with a strategic space to discuss emerging challenges in the space of AI like technology and data disruption, regulatory evolution and the balance between trust and outcomes through the lens of the patient. Throughout the event, attendees engage with regulators, academia, sponsors, vendors and CRO thought leaders, making it a hub for cross-sector collaboration and learning.  One key takeaway I had was when analyzing risks proportionally, one needs to consider whether they are addressing the symptoms of an issue or addressing the root cause and best-advancing solutions. 

The opening keynote was an absolute highlight of the first day of the Annual Conference.  Delivered by Matthew Griffen, a globally recognized futurist known for guiding organizations through digital transformation and disruption, his address set a bold tone for the conference, urging clinical data professionals to embrace the accelerating pace of change in healthcare and data science. His talk, titled “Navigating the Future of Clinical Data: Innovation, Ethics, and Human-Centric Design,” challenged attendees to rethink traditional data management paradigms and prepare for a future shaped by AI, automation, and patient-centric technologies. 

Griffen emphasized that the clinical data field is at a crossroads, where innovation must be balanced with ethical responsibility and privacy protection. He explored how emerging technologies—such as generative AI, predictive analytics, and decentralized data ecosystems—are reshaping clinical trials and regulatory landscapes. Importantly, he encouraged leaders to adopt a mindset of continuous learning and adaptability, highlighting that success in the next decade will depend on how well organizations can integrate human values into digital systems.  We already have Einstein-equivalent technical resources at our fingertips.  How we use them as clinical data professionals is what matters! 

The keynote concluded with a call to action:  With quantum AI coming in the next three years, this will be yet another fundamental step change.  We will need to lead with purpose, collaborate across disciplines, and build data systems that are not only efficient but also equitable and transparent. Together, this may be the step that shifts us from sick care to predictive healthcare.  Griffen’s insights resonated deeply with the audience, setting the stage for a conference focused on transformation, leadership, and the future of clinical data science. The session provided direct insights from regulators helping clinical data professionals prepare for upcoming compliance requirements like those outlined in ICH E6 (R3) and technological shifts in clinical research brought by AI adoption. 

There were a plethora of thought-provoking sessions throughout the conference with insights on AI, RBQM, people skills and trial modernization.  A highlight was the regulatory panel, which this year included FDA (U.S), MHRA (UK), BfArM (Germany), DKMA (Denmark), Swedish Medical Products Agency, and Health Canada.  This represented the largest panel of regulators ever hosted at an event and, as a Canadian, I was particularly happy to see Health Canada joining for the first time! 

The closing keynote, delivered by Dr. Sara Brenner, Principal Deputy Commissioner at the FDA, reflected on the profound impact of the COVID-19 pandemic on clinical trials and data management. Brenner explored how emergency-driven innovations—such as remote monitoring, decentralized trials, and regulatory flexibility—can be refined and sustained to shape the future of research. Drawing from her frontline experience in diagnostic innovation and policy, she will urge attendees to preserve the best of pandemic-era progress while reinforcing the scientific rigor and resilience needed for future public health challenges.   Joined on stage by Jonathan Andrus, Co-CEO CRIO, discussions expanded to the roll-out of the new agentic AI tool, Elsa, in the summer as the agency poises itself to modernize. 

Key takeaways from the conference include: 

• Data as a strategic asset: Not just classical data management data, but also real world, financial, operational and cross-functional data can be utilized to provide greater trial insights. 
• AI and regulatory readiness: Integrating AI into our clinical trials needs to move to being intentional by design instead of a retrofit as our regulations and global standards evolve further guardrails while allowing us to explore and innovate. 
• Community and collaboration: A strong sense of connection among professionals, with opportunities to network, share experiences, and co-create solutions for the future of clinical data management remains a cornerstone of SCDM and nothing can replace an in-person event! 

If you attended but were not able to join all of the sessions, know that recordings are already available on the conference app.  Key sessions will also be shaped into learning modules on elev8 for wider access. A tremendous thank you to all the speakers, co-chairs, and volunteers as well as our SCDM team in support.   Each event complements our global community as we bring local insights forward throughout the year and keep our community’s insights ever on the pulse of clinical data innovation.  

Board elections 

We are excited to share some important leadership updates announced at the recent SCDM 2025 Annual Conference: 

• A special thank you to Dr. Deepak Kallubundi, CCDM®, CPM, for your outstanding contributions to our certification programs, including most recently the CCDS Beta Exam! 

• Maria Craze, your years of service on the SCDM Board have brought invaluable expertise and leadership. We look forward to welcoming you as the keynote speaker at our first-ever SCDM Single –Day Event in Latin America this November. Thank you for your dedication and impact. 

• I am honored to share that I have been re-elected to the SCDM Board. Thank you to all SCDM members for your trust and continued support. 

• Please join me in congratulating and welcoming our newly elected board members: 
  Tanya du Plessis, Wayne Walker, and Julie Filipenko. We look forward to collaborating with you in the years ahead. 

• Dawn Kaminski, congratulations on your new role as Executive Secretary. We are excited for your leadership and look forward to your first newsletter to the SCDM community in 2026. 

• Shobhit Shrotriya, congratulations on being elected Vice Chair of SCDM. Your dedication and vision will be instrumental as we navigate the exciting opportunities ahead. 

• Finally, a heartfelt thank you to Patrick Nadolny. Nearly a decade ago, the idea of evolving from CDM to CDS began to take shape, and your unwavering commitment has been a guiding force throughout this journey. We are grateful for your continued support as an Executive Board Consultant. 

Together, we are shaping the future of Clinical Data Science. Thank you to all our members for being part of this global community and for your ongoing engagement. 

Education and Certification

We have recorded and are set to launch the CDM 101 webinar this fall, completing the trio of the CDA, CDM, CDS certification journey for our members. In addition, the CCDS Beta Exam launched in September and is free for those who would like to participate.  The Fall 2025 edition of JSCDM has also been released, including articles on EDC using Redcap, FDA’s GCP inspection assessment, a psych-oncology DCT implementation, SCDM best-practice on eSource transitions, CDISC deployment in academia and our EMEA executive perspective on the future of clinical trials with AI and DCTs.  Thank you, Claudine Moore, JSCDM Chief Editor, and the many authors and reviewers for bringing your insights to our journal this quarter!  As of this September, our Journal articles have had over 330, 000 views! It is great to see there’s now a convenient link on the JSCDM page to MRCT’s glossary.  Did you know there’s also an SCDM glossary? The Global Academic council launched a poll on AI at the Annual Conference.  We are keeping the poll open through the end of the year to collect further responses.  If you would like to participate, click here.

Upcoming Events 

We still have exciting events to come in the last quarter of 2025, including: 

1. Our inaugural  event in Bogotá, Colombia on 21 November 

1. Hyderabad, India 4-6 December, and 

1. Tokyo, Japan 10-11 December 

Volunteer 

Our SCDM volunteer community is amazing.  I am continually inspired by the quality and dedication of our supportive network of volunteers.  Each contribution drives our global insights forward in a collaborative voice of global acuity. If you are interested in taking part, please check out this link!  I will be handing my SCDM Executive Secretary duties off to Dawn Kaminski this year and I know you will be in kind hands.  I have truly appreciated being the voice of SCDM over the last couple of years and look forward to continued support as your elected Board member.  I will leave you with a bit of poetic fun and look forward to crossing paths down the road!  

The Nonsense Table 

A table sat in quiet gloom,

Its data muddled in frightful doom.

The queries came, a dreadful tide,

Till RBQM opened wide.

It swallowed nonsense with voracious care,

And sorted values here and there.

Every cell now clear insight —

Revealing at last data’s might.

Cheers, Stephen

Stephen Cameron

Secretary, SCDM Board of Trustees