2nd DECENTRALIZED & HYBRID CLINICAL TRIALS WORLD CONGRESS 2026 EUROPE
Redefining Clinical Research Through Decentralization, Technology, and Collaboration
London, United Kingdom
Day 1 - Wednesday 25th February 2026
Regulation, Collaboration, and Patient Engagement
- Key updates on the CTR and its practical implications for DCT operations
- Coordinating approvals via the Clinical Trials Information System (CTIS)
- Managing ethics submissions and multi-country compliance challenges
- Building trust and transparency through harmonized EU oversight
Moderator:
Panelist:
- How the EU4Health and European Health Data Space (EHDS) initiatives enable DCT expansion
- EMA’s digital strategy and its implications for decentralized research oversight
- The evolution of national frameworks for telemedicine and remote care integration
- Envisioning Europe’s role as a global leader in digital clinical innovation
- Implementation lessons from Spain, Germany, France, and the Nordics
- Cross-border participant management and data sharing under GDPR
- Addressing operational fragmentation between national health systems
- Opportunities for mutual recognition and data reuse in the EU
- Adapting GCP principles for hybrid and home-based trial oversight
- Maintaining clinical responsibility across decentralized trial settings
- Leveraging digital dashboards and telemonitoring tools for supervision
- Supporting site staff through EU-level digital training frameworks
- Reducing barriers to participation for rural and aging populations
- Strategies for multi-language patient interfaces and digital inclusion
- Leveraging telehealth to improve representation in rare disease studies
- Building national digital literacy programs for broader engagement
- Advances in validated wearables, eConsent, and ePRO platforms
- Interoperability with hospital EHR systems
- Ensuring MDR/IVDR compliance for medical device-linked technologies
- Real-world deployment case studies from multi country trials
- Integrating GDPR, ethics, and consent requirements from inception
- Incorporating remote assessments and digital biomarkers
- Aligning decentralized protocol elements with local legislation
- Collaborative approaches to co-design with patients and advocacy groups
- Importance of strong relationship with sites and site network critical to the success of clinical trials
- Strategies sponsors can develop to build strong site relationships at scale.
- Key factors that are highly valued by both Contract Research Organisations (CROs) and Sponsors.
- Future directions for improving relationships with sites and site networks
- Managing decentralized data securely across multiple jurisdictions
- Best practices for anonymization and data minimization
- Cyber resilience in sponsor, CRO, and technology partnerships
- Building public confidence through transparent privacy frameworks
- Blending virtual and in-person interactions to enhance experience
- Supporting patients through multilingual, digital, and in-clinic channels
- Ensuring safety, adherence, and satisfaction in hybrid environments
- The path toward a unified, inclusive European patient-centric model
- Implementation of centralized monitoring models in EU pilot studies
- Handling eSource verification and remote audits under GCP
- Coordinating across multi-language data environments
- Lessons learned from recent decentralized oncology and vaccine trials
- Fostering pan-European ecosystems for DCT service delivery
- Integrating SMEs and digital health star tups into large-scale trials
- Coordinating cross-border logistics, training, and support networks
- Establishing standardized performance and quality metrics
Co-located with the Patient Centricity & Collaboration World Congress 2026 Europe.
Joint Networking & Exhibit Area.
