Archives: Agenda

• The UAE as a prominent hub for research and clinical trials, driven by a focus on healthcare innovation and patient-centric approaches
• The UAE’s comprehensive regulatory framework that supports and facilitates clinical research
• Training and upskilling local researchers and clinicians in research methodologies
• Prioritizing patient-centric approach, engaging patient communities and advocacy groups

• Explore how PSI integrates GenAI for protocol similarity searches and enrollment rate predictions, improving accuracy and efficiency in clinical trial planning
• Learn how VISIONAL™ incorporates three new data sources to enhance site performance analysis and offer insights across 56 countries, supporting better decision-making
• Discover how VISIONAL™ enables sponsors to quickly generate multi-country feasibility scenarios and budgets in under 30 minutes, streamlining the planning process

• The challenge: Disconnected systems creating blind spots in trial management
• The opportunity: AI as the connective tissue between documentation and execution
• The Intelligent Trial Assistant: Natural Language Queries Across ETMF and CTMS
• AI-Driven Inspection Readiness: Connecting Document Quality to Trial Execution
• Predictive Trial Health: Using AI to Connect the Dots Between Documents and Operations
• Smart Document Classification Meets Smart Workflow: End-to-End Trial Automation

• Working closely with patients, caregivers and advocacy groups in clinical trial design
• The importance of building a close relationship with patients for trials where patients are the expert in their disease
• Reducing the financial burden of clinical trial participation on patients
• How to make trial participation easier on patients: where are the main hurdles impacting enrolment?
• Building long term relationships with patients post clinical trials

• Demystifying the Importer of Record (IOR) and Exporter of Record (EOR) functions and reframing it as a strategic enabler of cost efficiency, regulatory compliance, and accelerated timelines in global clinical trial logistics
• What IOR/EOR really means in a clinical context: Role in customs declarations, tax responsibility, and compliance.
• IOR providers’ responsibilities through HS classification, valuation review, and pre-clearance planning.
• Best-fit model: When and where to outsource vs. manage in-house.
• Tax pitfalls in outsourced IOR: Misclassification of goods (e.g., placebo vs. commercial drug), overpaying duties or VAT due to poor documentation control, and ignoring the available tax saving opportunities.
• Tax planning by design: The importance of implementing a sound IOR strategy to avoid the highlighted tax pitfalls.
• Walk away with a deeper understanding of IOR/EOR as a strategic lever for improved global clinical execution, guidance on how to incorporate an outsourced IOR for global clinical trials and a “Red Flag Checklist” with critical questions to vet vendors for outsourcing IOR/EOR

• Sponsors’ roles in supporting sites in order to increase trial efficiency and decrease overall timelines
• Where can clinical trial sponsors better support patients with rare diseases both during trials and in the long term?
• Lessons learned from Moderna’s experience of site and patient engagement during clinical trials

• Navigating new regulations around clinical trials smoothly and successfully
• The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
• Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?
• How may geopolitical and geoeconomic events including the financial crisis, the Inflation Reduction Act and the upcoming election impact clinical trials in the US?
• Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5 years?

MODERATOR: Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

• Examining common pitfalls in site selection for complex therapies and how data informed approaches can help sponsors overcome them
• Exploring strategies to balance sponsor preferred sites, CRO recommendations, KOL influence, and community investigators for stronger performance
• Understanding how to connect internal knowledge with external databases to drive greater accuracy and efficiency in early development
• Reviewing real world case studies that highlight innovative solutions to early phase challenges in complex therapies, from timeline management to site readiness

A look at the pros and cons of various outsourcing models including Full-Service Outsourcing (FSO), Functional Service Provision (FSP), and single service. A discussion of the benefits of a hybrid approach are explored.