Archives: Agenda

• 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.

• Biospecimens are foundational for all clinical trial data: they are data at an early stage
• Errors in collection, logistics, or analysis can have major impacts.
• Pre-analysis processes (requirements, collection, logistics, lab contracting, analysis, data transfer) are critical and should not be left to chance.
• Clinical Trial logistical design is increasingly complex, and errors can occur at any stage
• Compliance with evolving regulations is essential.
• Informed consent, ownership rights, and privacy are key issues.
• Transparent policies, ethical oversight, and robust tracking of samples and data are necessary
• We need to Focus on the entire lifecycle to ensure compliance and trust.

• How to keep up with rapid changes in technology?
• How do all the systems interact with each other?
• What is the ultimate goal?

• Designing the study and getting IRB permission to run it
• Site selection
• The importance of electronic data capture
• Why a sponsor’s representative must be there
• The physician’s or surgeon’s muscle memory