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Session 3, Track B: Manage Trial Evolution: Aligning Patient-Centric DCTs and Digital Governance in Canada
Session Chair(s)
Nessrine Hanna, MSc
Director, Clinical Operations, AbCellera, Canada
Rosemarie Clarke, RN, PMP
Translational & Clinical Research Consultant, AllWright-Clarke Research Solutions Inc., Canada
While modern hybrid decentralized clinical trial (DCT) models bring research closer to Canadian patients, site-level adoption frequently lags due to fragmented digital workflows, operational complexities, and shifting Health Canada regulatory expectations. This session demonstrates how cross-functional teams in academia and industry can unify clinical operations and regulatory strategy by transitioning into synchronized digital ecosystems. Participants will analyze practical methods to deploy strategic partnerships with specialty nursing or pharmacy networks and implement digital tools that securely manage remote medication delivery across varying institutional privacy rules. Ultimately, attendees will walk away with a scalable framework to design patient-focused trials that ensure continuous compliance, reduce site burden, and maintain constant inspection readiness.
Learning Objective : At the conclusion of this session, participants should be able to: - Design hybrid trial protocols that integrate innovative trends and elements such as home nursing and local pharmacy networks.
- Formulate operational workflows that integrate digital infrastructure with Health Canada expectations.
- Explore site-level operations to proactively mitigate institutional privacy and compliance risks
Speaker(s)
Harry (Seung Bae) Park
Manager, Scientific Affairs Liaison, Bayshore Specialty Rx, Canada
Advancing Hybrid Decentralized Clinical Trial Models to Support Patient-Centre Research in Canada
Sara Saunders, MHA
Director, Global Regulatory Affairs, Florence Healthcare, United States
Aligning Clinical Operations and Regulatory Strategy to Accelerate Trials in Canada: The Role of Digital Infrastructure
Katarina Susnjar
Compliance and Enforcement Specialist, Clinical Trial Compliance Program (CTCP), Health Canada, Canada
Speaker
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