Use AI to Accelerate RWD Transformation for Regulatory Submissions
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About this webinar
Real-world data (RWD) is increasingly used to support clinical development, safety evaluation and regulatory evidence generation. However, converting electronic health records, claims and registry data into Clinical Data Interchange Standards Consortium (CDISC)-compliant datasets requires more than simple data mapping. Patient histories must be reconstructed, coding systems aligned and clinical context preserved to ensure traceable, review-ready evidence.
This webinar will explore a practical framework for transforming RWD into submission-ready CDISC datasets through data fitness assessment, source harmonization, controlled mapping, SDTM implementation, validation and end-to-end traceability. The featured speakers will discuss the importance of maintaining data quality, consistency and reproducibility throughout the transformation process to support regulatory review.
The session will also explore how AI can accelerate mapping, terminology reconciliation, specification development and quality control while maintaining regulatory compliance through human oversight, provenance tracking and conformance testing. Attendees will gain insights into how these approaches can reduce manual effort, improve workflow consistency and support scalable RWD evidence generation without compromising data integrity.
Register for this webinar to learn how AI-assisted RWD transformation can improve data traceability, streamline CDISC mapping and strengthen regulatory readiness.
Who should attend
- Head of Real-World Evidence (RWE) or Observational Research
- Head of Epidemiology
- Evidence Generation or Integrated Evidence leaders
- Biometrics or Statistical Programming leaders
- Medical Evidence leaders
- Regulatory Affairs/Science or Data Standards leaders
- Oncology Clinical Development leaders
What you will learn
- Evaluate whether RWD is fit for regulatory-grade evidence generation
- Build traceable, submission-ready CDISC datasets from heterogeneous healthcare data sources
- Establish the documentation and governance required to support regulatory review and reproducibility
- Apply AI responsibly to accelerate RWD-to-CDISC transformation while maintaining human oversight and compliance
- Reduce manual effort and improve consistency across mapping, validation and quality-control workflows
- Develop a scalable roadmap for operationalizing AI-assisted RWD evidence generation
Featured Speakers
Jamie Powers
Jamie Powers serves as Senior Vice President of Biometrics at Ephicacy and leads the project-based services unit. In this role, he supports the continued growth of Ephicacy’s programming and biometrics services while advancing data-driven approaches that integrate clinical trial and real-world evidence.
Jamie brings more than two decades of experience spanning biostatistics, clinical operations analytics, artificial intelligence and machine learning (AI/ML) and real-world evidence (RWE). His career has included leadership roles across sponsor, CRO and technology organizations, including Quintiles, SAS Institute, ConcertAI and Takeda Global Clinical Development.
A Biostatistician by training, Jamie has extensive experience integrating clinical trial data with real-world data to enhance study feasibility, inform protocol development and support portfolio and development strategy. He has also led initiatives applying AI and machine learning across the clinical life cycle, including protocol optimization, site selection, enrollment forecasting and risk monitoring.
Jamie is recognized for bringing together cross-functional teams to deliver innovative solutions for biopharmaceutical clients. He has led and mentored teams of statisticians, analysts and data scientists while also working closely with commercial and client-facing organizations to translate complex analytics into actionable insights.
Jamie holds a DrPH in Biostatistics from the University of North Carolina at Chapel Hill, an MSc in Statistics and a BSc in Human Biology from the University of Guelph.
Shekhar Thumake
Dr. Shekhar Thumake is Head of AI at Ephicacy, where he leads the design and evolution of agentic AI capabilities across the company’s biometrics and data operations. He works closely with clients and delivery teams to reimagine how clinical trial data workflows are built, moving beyond point automation toward intelligent, standards driven systems and within the compliance boundaries the industry demands.
A techno-functional leader with nearly two decades of experience, Dr. Shekhar has built his career at the intersection of clinical domain depth and applied AI. He has built AI innovation functions from the ground up, shaping multiyear road maps that prioritize the highest impact opportunities across the clinical trial life cycle.
His hands-on work includes protocol digitization using CDISC’s USDM standard to unlock interoperability across clinical applications, AI systems that mine unstructured clinical notes to support patient eligibility and identification, natural language tools that protect sensitive patient information and predictive intelligence platforms that help identify high performing trial sites.
Dr. Shekhar is equally recognized for his consulting acumen in the clinical development domain. He has a strong track record of partnering with senior client and sponsor stakeholders to translate ambiguous business challenges into well scoped, technically sound solutions. He has represented organizations through proposal development, solution design and executive-level engagements.
A Physician by training with a degree in Alternative Medicine, Dr. Shekhar brings a distinctive clinical lens to technology leadership, one that is further shaped by a Master’s degree in Business Management and postgraduate study in data science and big data analytics. This combination of medical grounding, business acumen and technical depth defines his approach to building AI that biometrics teams can trust.
His passion for innovation with AI extends beyond work. He is an avid follower of the AI industry and spends much of his time reading and listening to leading voices in the field, tracking where the technology is heading in the near and long term.
Partner for this event
Ephicacy
Ephicacy is a global biometrics CRO and strategic partner to biopharma organizations, delivering biostatistics, statistical programming, data management, and real-world evidence solutions. With more than 20 years of experience, 500+ global professionals, and support for over 1,230 studies and projects across 100+ therapeutic indications, we help clients navigate complexity, reduce operational burden, and advance programs efficiently. Trusted by 4 of the top 10 pharmaceutical companies and hundreds of biotech, medical device, and diagnostic organizations, Ephicacy offers flexible FSP, project-based, and hybrid delivery models tailored to client needs. Through deep expertise, scalable global delivery, and long-tenured teams, we provide the consistency and reliable execution required to support successful clinical development outcomes. Explore Ephicacy’s capabilities and expertise in more detail at www.ephicacy.com.