Dear SCDM Friends,

Twenty twenty five is coming to an action-packed conclusion with our single day Latin America event launch as well as multi-day events in both India and Japan.  We continue our outreach to academic institutions as we seek to inspire and invigorate our next generation of clinical data professionals.  From our certifications track, the CCDS beta exam enrolled 250 volunteers within a month!   

Conference updates

We launched our Bogotá, Colombia single day event on November 21, 2025.  Prior to the event we had an academic outreach at the Universidad de los Andes hosted by Professor David Bigio Roitman, Director of the Department of Biomedical Engineering.  Dozens of students from faculties across the campus joined us for a highly-interactive overview of our industry, with many joining for the single day event to take a deeper dive.  The conference marked SCDM’s first local event in Latin America as we continue building our global event model, bring the conference to local audiences around the world.  The event fostered collaboration within the local clinical data management community, celebrated knowledge sharing and blended both Spanish and English content for a balanced and welcoming environment for all attendees.  A big thank you to the two Luis’s (Torres and Ávila) for opening the conference and for the many SCDM volunteers who worked tirelessly over a year and a half to bring this event to life.  I had the honour to step in and speak as the opening keynote for the event on “my why,” and was inspired by many in attendance joining in and sharing their personal journeys and inspirations. Maria Craze, we missed you tremendously this year!  It was mentioned so many times how foundational your leadership and organization has been to the growth of the CDM community in the region.  I know they can’t wait to have you share your inspiring story at the next LatAm event (date and location to be announced in 2026).  As we work the details out on the next single-day event, we are also already working on a LatAm leadership forum to come to Mexico in April.  Topics highlighted personal experiences, the minds of our future and enhancing our bridge between sites and DM through communication and technology innovations.  A special thank you to Bioforum, the Data Masters for hosting the social event.   

The SCDM India 2025 Hyderabad event was from the 4th to 6th of December. Focused on bringing together clinical data management professionals across South Asia. Anand S, a Large Language Model Psychologist, provided the opening keynote and explored how agents can automate or augment the clinical data workflow from design and capture to cleaning monitoring, and submission, as well as where they cannot be safely used yet. 

Conference topics over the three days highlighted advancing knowledge in data integrity, regulatory compliance, and technology-driven solutions for clinical trials. The program featured keynote sessions on global CDM trends, workshops on risk-based data management, and discussions on leveraging AI and automation for data quality. It also provided networking opportunities for professionals from CROs, sponsors, vendors, regulators and academia, fostering collaboration and knowledge exchange in a rapidly evolving regulatory landscape.  The first day also had an Academia outreach and we did something special for this event.  Hosted at the St. Ann’s College for Women, well over 600 students local to or from surrounding colleges and Universities joined to hear and share insights on unleashing career opportunities in Clinical Data Management.   Reading posts on the event, it was clear the inspirations were shared both by students and speakers alike.  A special thanks to Oryxion for sponsoring this milestone event and for ClinoSol Research for supporting local community outreach and engagement! 

The event emphasized practical strategies for implementing decentralized trials, improving data governance, and aligning with global standards such as CDISC and ICH E6(R3). Attendees engaged in interactive panels addressing challenges in emerging markets, vendor oversight, and patient-centric data collection. With strong participation from industry leaders and regional experts, the Hyderabad conference reinforced SCDM’s commitment to building capacity and promoting best practices in clinical data science across India and neighboring regions. 

Rose Kidd’s closing keynote focused on leadership in clinical data management and the future of global collaboration, emphasizing how organizations can adapt to rapid technological changes while maintaining data integrity and compliance. She highlighted strategies for empowering teams, fostering innovation, and building sustainable talent pipelines to meet evolving industry demands. 

The SCDM Tokyo 2025 Conference (December 10–11, 2025) extended this year to a two-day regional event focused on advancing clinical data management practices in the Asia-Pacific region. Hosted in Tokyo, Japan, it featured sessions on data integrity, risk-based monitoring, and regulatory compliance, with a strong emphasis on ICH E6(R3) and CDISC standards. The program included an opening address by professor Munenori Takada, an update on SCDM’s eSource initiative by Jonathan Andrus, SCDM Executive Treasurer, and a keynote address by Ward Lemaire, Vice Chair of SCDM.  Ward provided an overview of SCDM’s 2030 vision as we lead innovative clinical data science to advance global health through a patient-driven, inclusive and collaborative model. from global thought leaders, interactive workshops on AI-driven data cleaning, and panels discussing decentralized trials and patient-centric data strategies. Networking sessions connected professionals from CROs, sponsors, and academia, fostering collaboration and knowledge sharing. 

The closing day highlighted future trends in clinical data science, including automation, real-world evidence integration, and talent development for emerging markets. Speakers stressed the importance of harmonizing global standards, leveraging technology for efficiency, and building resilient teams to meet the demands of complex trials. The event reinforced SCDM’s commitment to expanding its footprint in Asia and supporting innovation in clinical data management. 

SCDM board representatives also attended the European Medicines Agency GCP IWG, where practical regulatory insights were shared on ICH E6 R3, AI, EMR and  RBQM.  Of particular note was a shared lessons learned of a LLM technology implementation.  For this example, version control was possible to show clear validation.  There were discussions on what validation would look like for a Generative AI solution with ongoing learning.  The regulators are willing to explore scenarios with the sponsors and encourage early engagement.  In general, I think it may be that we look to similar validation steps to what we would do for a human.  After all, we don’t typically validate new versions of ourself as we experience ongoing learning throughout a trial. 

Thank you to all of the co-chairs, speakers, sponsors, vendors and attendees that came together to make each of these conferences a resounding success as we bring the conversation to you, the members, around the globe!  

Education and Certification

Here’s our link to details on CDA, CDM, and CDS certifications.  The CCDS Beta registration is closed after a flood of interest and we are assessing exams to make final tweaks for the formal launch in 2026. 

Many are already taking advantage of the Elev8 learning experience platform as new content like our six masterclass sessions on soft skills such as critical thinking, leadership and team management come online.  For example, I took the one based on Rik Vera’s keynote , “Surfing the wave of change:  Inspiration about fast change and innovation.”  It was highly immersive and provided practical takeaways as you explored the three box thinking model in a practical and interactive setting.  What are the boxes? 

Box 1: What should we preserve? (Core strengths and current business) 

Box 2: What should we let go? (Processes or models that no longer serve the future) 

Box 3: What should we create? (New ideas, technologies, and business models for tomorrow) 

Ready to learn more? Click here. 

Baltimore Industry Summit Highlights

The 2025 Industry Summit, held during the SCDM Annual Conference in Baltimore, brought together senior leaders from across the clinical data and trial ecosystem. In a confidential, cross-company setting, participants engaged in open dialogue about the future of clinical data management (CDM), the impact of AI, and the evolving role of data professionals. The conversations were guided by a shared commitment to collaboration, despite competitive boundaries.  In the spirit of timely sharing, please see key highlights below. 

1. Pemise

The clinical data landscape is undergoing a profound transformation. Artificial Intelligence (AI), once a speculative tool, is now actively reshaping how trials are designed, executed, and analyzed. The industry summit gathered insights from leaders across the sector as they convened to explore the future of clinical data management (CDM). Through open dialogue, participants challenged assumptions about workforce reduction, regulatory readiness, and the role of standards in an AI-driven world. They explored the three-layer framework for AI deployment posed in the  November JSCDM paper, SCDM Executive Committee Perspective:  The Future of Clinical Trials with AI and Decentralized, Hybrid and Data-driven Approaches.  They examined the evolution of data roles and offered strategic recommendations for navigating the next era of clinical research. 

2. Introduction 

The 2025 Industry Summit was not a typical conference session. It was a curated space for candid conversation — a rare moment where competitors became collaborators, united by a shared urgency to rethink the future of clinical data. The backdrop was clear: AI is no longer theoretical. From generative models to agentic systems, technology is accelerating faster than governance, culture, or infrastructure can keep pace. 

Participants brought diverse perspectives, but a common theme emerged: transformation is inevitable, but not yet intentional. Many organizations are reacting to change, rather than shaping it. The summit offered a pause — a chance to reflect, recalibrate, and reimagine what clinical data management could become if designed for the future, not the past. 

Conversations were distilled into a structured reflection. It does not aim to summarize every viewpoint, but rather to surface the most resonant insights and explore their implications for the industry at large. 

3. Positioning Statement

The dominant narrative around AI in clinical trials often centers on efficiency — and by extension, reduction. Fewer people. Fewer processes. Faster outcomes. But this framing misses the point. AI is not a substitute for human expertise; it is a catalyst for redefining it. 

At the summit, leaders consistently rejected the idea of large-scale workforce reduction. Instead, they envisioned a shift: from transactional roles to strategic ones, from data entry to data orchestration. Roles like data curator, AI trainer, and cross-functional integrator are emerging — roles that require not less skill, but different skill.   

The evolving regulatory landscape (e.g. EU AI Act, FDA credibility frameworks) presented both challenges and opportunities. Participants stressed the need for proactive engagement with regulators and the importance of building internal expertise to navigate risk-based frameworks. 

4. Shared Perspectives 

Despite differing organizational contexts, several points of convergence emerged: 

• AI adoption will be gradual but exponential — starting with 5–10% impact and scaling rapidly. 

• Efficiency gains will not reduce workload — they will enable broader portfolios and deeper insights. 

• Cross-functional collaboration is essential — data teams must work alongside clinical, medical, and statistical functions to realize AI’s full potential. 

• Change management is the bottleneck — not technology. 

5. Disruptive Ideas

The summit surfaced several bold, forward-looking concepts: 

• Robotic data capture: envisioning AI-powered agents at sites, passively collecting and transmitting data in real time. 

• Avatar-based patient support: personalized AI companions guiding patients through trials. 

• Direct-to-regulator data pipelines: bypassing traditional submission formats in favour of real-time, structured data exchange. 

• Unified control arms: pooling synthetic or real-world data across trials to reduce patient burden and accelerate insights. 

6. Challenges Identified 

The path forward is not without friction: 

• Fragmented tech ecosystems: Sites struggle with multiple platforms, logins, and devices. 

• Lack of shared infrastructure: Industry-wide foundational layers remain aspirational. 

• Regulatory ambiguity: Risk-based frameworks lack clarity, creating hesitation. 

• Cultural resistance: Many professionals still equate AI with job loss, rather than opportunity. 

7. Preliminary Recommendations 

To move from insight to action, participants suggested: 

• Investing in AI literacy across all functions. 

• Redefining roles to reflect new capabilities and responsibilities. 

• Building modular, interoperable tech stacks that support semantic integration. 

• Engaging regulators early to co-create scalable, compliant solutions. 

• Documenting and sharing use cases to build trust and momentum. 

8. Conclusion 

The leaders aligned that AI not a threat, but a transformative force that expands the scope of what data professionals can do. It argues that the future of CDM is not about doing less, but about doing more — differently, and with greater impact. 

Global Academic Council AI Survey

Speaking of AI, we would love to hear from you too!  The SCDM Global Academic Council circulated a survey at the annual conference.  If you responded, excellent, we appreciate your response!  We are widening our outreach to the wider SCDM community to reach a broader response community.   This survey will support research aimed at understanding current practices, perceptions, and future directions of use of AI in CDM. Your responses will be used solely for research purposes. The survey begins with five demographic questions to help us better understand the background of respondents followed by 36 AI-related questions that serve as the basis for our study.  The entire survey should only take 5 minutes of your time to complete and is intended to answer three foundational questions: 

1. What is the current state of AI adoption and effectiveness in clinical data management (CDM)? 

2. What are the ethical, regulatory, and operational challenges associated with integrating AI into CDM workflows?

3. How is AI transforming the role and skillset of clinical data managers?

Take a moment for the survey and be a part of the data driving the conversation! 

Upcoming Events

2026 is just around the corner!  Our EMEA Conference has already been announced on 3-6 May in Copenhagen, Denmark, with topics selected and speaker abstracts open for submission!  We also have the annual conference announced in Raleigh, North Carolina 14-17 September.  Watch for session abstract requests to come out soon, along with announced dates for the many global events throughout the year. 

Volunteer

SCDM volunteering can take your inspiration to new heights.  Whether it is writing, speaking, inspiring, mentoring or editing, there are a plethora of ways for you to step our SCDM community forward.  With a new year giving new opportunity, this may be your right time to jump in and volunteer!  We can’t do it without you and look forward to seeing your inspiration take shape into action! 

Cheers, Stephen

Stephen Cameron

Secretary, SCDM Board of Trustees