Agenda Archive

Clinical trials in Japan: a new era of opportunity for global sponsors

Japan as one of the largest pharmaceutical markets presents unique challenges and opportunities
Overview of the current clinical trial environment, government support and major regulatory reforms
What’s the reward of running clinical trials in Japan and Japan market entry?

Operational inefficiencies quietly erode a drug’s Probability of Technical and Regulatory Success (PTRS) and reduce overall asset value
Biotechs must shift from reactive oversight to proactive strategies grounded in near-term visibility and actionable data
Same-day insights into trial conduct help de-risk execution, protect endpoints, and accelerate development timelines
Faster, cleaner data drives confident decisions and signals operational strength to investors and partners
Lessons from 25+ years in drug development offer a practical blueprint for embedding operation excellence into biotech strategy

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

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