Archives: Agenda

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.