Archives: Agenda

Driving asset value through operational precision

  • 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

Beyond Integration: How AI Creates a Clinical Trial Platform

  • 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

PSI’s VISIONAL: enhancing feasibility and enrollment predictions with GenAI

  • 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

Beyond the Middleman: Strategic Outsourcing of IOR/EOR for Global 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

Strategic site selection in early development: Meeting the demands of complex therapies

  • 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

The importance of accurate and consistent sample collection and management in clinical trials

  • 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.