Standards are frequently misunderstood and maligned as stifling innovation, adding burden and increasing costs. However, standards can reduce operational burden by improving data quality, interoperability and research readiness. This webinar explores how standards support more reliable data sharing and AI-enabled clinical research.
Standards can also serve as a first line of protection in AI-enabled development. Without established standards, AI systems may propose inconsistent terminology or select terms without proper grounding.
Standard protocol elements and study-related definitions now form the basis of ICH M11, a “globally harmonized framework for organizing and describing core protocol content in a way that can support both human readability and downstream machine processing.” Looking further upstream, the EU xSHARE project is demonstrating that harmonizing data standards across HL7, CDISC, IHE and ISO, toward a standard International Patient Summary (IPS), can enable the reuse of healthcare data for research.
AI adds another dimension, as high-quality, standardized data supports more reliable results and enables technology tools and statistical programs to advance more efficiently. Together, these initiatives position standards not as documentation overhead or a mapping burden but as foundations for faster, more reliable research that benefits patients globally.
This webinar brings together a panel spanning regulatory science, data-sharing infrastructure, European health data policy and clinical technology to explore the ICH M11 computable protocol, the EU xSHARE project and AI implementations at the Clinical Research Data Sharing Alliance (CRDSA). Each panelist will share the interoperability challenges their initiative addresses, then join a discussion of the barriers that remain and how they might be tackled. Attendees will leave with a clearer view of how standards form the foundational architecture for the next generation of digital health and AI-driven clinical research.
Register for this webinar to learn how data sharing standards can improve interoperability, strengthen AI outputs and accelerate research readiness.
Speakers
Rebecca Daniels Kush, PhD, President of Catalysis and Founder and President Emeritus of CDISC
Rebecca Daniels Kush, PhD, is the President of Catalysis and Founder and President Emeritus of CDISC. Her career has focused on the use of healthcare data and standards in sync to streamline clinical research and accelerate learning health cycles. She currently serves as a volunteer for the EU-funded xSHARE project, is on the Board of the Learning Health Community and is an Associate Editor of the Learning Health Sciences Journal.
Dr. Kush led the Clinical Data Interchange Standards Consortium (CDISC) from 1997-2017, while it developed a suite of global data standards and terminology to support clinical research in over fifty therapeutic areas and initiated the Shared Healthcare and Research Electronic Library (SHARE, now known as the CDISC Library). She served on the HL7 Board during the period of FHIR adoption and created collaborations with HL7, NCI and CDISC around the ISO/HL7/CDISC BRIDG model and the Protocol Representation Standard, which now serve as the basis for the ICH M-11 initiative related to digital protocols. She also founded the CDISC Europe Foundation to partner with IMI (IHI) on projects such as EHR4CR and xShare. Prior to founding CDISC, Dr. Kush worked with the US National Institutes of Health (NIH), academia, a global clinical research organization (CRO) and biopharma companies in the US and Japan. Dr. Kush earned her doctorate in Physiology and Pharmacology from the University of California, San Diego School of Medicine and a BS in Biology and Chemistry with honors from the University of New Mexico.
Message Presenter
Ron Fitzmartin, PhD, MBA, Principal Consultant, Decision Analytics LLC
Ron Fitzmartin, PhD, MBA, is a Regulatory Science and Drug Development Leader with more than 25 years of experience advancing regulatory policy, data standards and modern submission processes across government and industry. From 2012 to 2025, he served at the US Food and Drug Administration as a Senior Informatics Advisor in CDER and CBER, where he led standardized study data policy initiatives, supported FDA’s IDMP work and held leadership roles in ICH, including Regulatory Chair for the ICH M8 Electronic Submissions EWG and Rapporteur for the ICH M11 Clinical Protocol Template EWG. He currently serves on the CDISC Board of Directors.
Ron is the Principal Consultant at Decision Analytics, LLC, where he advises regulators, global health partners and industry on global data standards, submission modernization, end-to-end data governance and the practical evaluation of generative AI tools for regulatory use. Earlier in his career, he held senior roles at Daiichi Medical Research, Daiichi Sankyo and Purdue Pharma, leading biostatistics, clinical data management and informatics functions.
Message Presenter
Aaron Mann, Chief Executive Officer, Clinical Research Data Sharing Alliance (CRDSA)
Aaron Mann is the CEO and Co-Founder of the Clinical Research Data Sharing Alliance (CRDSA), where he designed and is engineering Project Concordia, a production-grade agentic AI harmonization platform for life sciences research data, built as reproducible, auditable infrastructure. Aaron led the 2021 multi-stakeholder effort to establish CRDSA and initially served as its Senior Vice President, Data Science. Before co-founding CRDSA, he led Roche’s industry data-sharing collaborations and, as the Industry Lead for TransCelerate BioPharma’s data-sharing platform, drove the industry’s COVID-19 patient-level data-sharing initiative.
With over 25 years of experience spanning global enterprises, high-growth technology companies and early-stage startups, he brings deep expertise in AI-enabled data architecture, cross-organization collaboration and the regulatory and governance frameworks that shape how AI can be responsibly deployed. Aaron works where AI meets research-data infrastructure, using the latest tools to solve long-standing data interoperability and reuse challenges.
Message Presenter
Dipak Kalra, President, The European Institute for Innovation through Health Data (i~HD), Professor of Health Informatics, UCL, Visiting Professor, University of Gent
Professor Dipak Kalra is President of The European Institute for Innovation through Health Data (www.i-hd.eu), a Professor of Health Informatics and a former London General Practitioner. He plays a leading international role in Electronic Health Record R&D, including the reuse of EHRs for research. He has led the development of ISO standards on EHR interoperability, personal health records and data protection. He contributes to several European Commission-funded projects focused on accelerating the adoption of digital health innovations, improving the quality, interoperability and reuse of health data for research and supporting the development of the European Health Data Space. His work also includes advancing the collection and use of health outcomes to support value-based care, developing an AI-powered federated learning platform for lung cancer and improving patients’ understanding of their medications to strengthen confidence and adherence.
Message Presenter
Sean Connolly, Chief Product and Technology Officer, Evinova
Sean Connolly is the Chief Product and Technology Officer at Evinova, where he leads Product Strategy, Platform Development and the advancement of AI-driven solutions aimed at transforming clinical development. He oversees the integration of technology, data and analytics to streamline the design and execution of clinical trials, with a focus on improving efficiency, reducing costs and accelerating timelines.
Prior to joining Evinova, Connolly held senior leadership roles across technology and product organizations, where he focused on building and scaling enterprise platforms, driving digital transformation and applying data and AI to complex, regulated environments such as healthcare and life sciences. He brings a background that blends product innovation with operational execution, shaped by experience working at the intersection of software, data and clinical research. Connolly holds a strong academic foundation in technology and business-related disciplines, which underpins his focus on applying artificial intelligence in practical, scalable ways within regulated industries. His work emphasizes enabling more informed decision-making while maintaining high standards for data security, compliance and scientific rigor.
Sean holds a Master of Science in Information Systems and a Bachelor of Business Administration and Computer Science from George Washington University.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical Researchers (Protocol Authors, Clinical Development and Operations professionals, Investigators, Monitors and Coordinators)
- Data Analysts, Managers and Programmers/Statisticians
- Innovation and AI-focused leaders
- Patients/Volunteers
What You Will Learn
Attendees will gain insights into:
- How applying standards from the start streamlines research processes and supports computable protocols
- How health data reuse can accelerate research and support the interoperability and quality goals of the European Health Data Space
- How standards development organizations can align frameworks and work together more effectively
- How standards improve data quality, enable data sharing and strengthen AI-generated results
- How science-based digital health approaches can support innovation and better health outcomes
- How regulatory, technology and infrastructure perspectives shape the use of standards across clinical research
Xtalks Partner
Evinova
Purpose-built by healthcare for healthcare, Evinova empowers life science leaders to accelerate better health outcomes with digital and AI-native solutions that optimize clinical development from end to end
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