Archives: Agenda

Navigating ICH GCP E6 (R3): updates and best practices

  • Understanding the changes in ICH GCP E6 (R3) vs ICH GCP E6 (R2) in a user-friendly manner·
  • Implementing effective compliance measures to ensure alignment with evolving regulatory expectations
  • Identifying key challenges and ways to overcome them

 

 

Breaking down barriers: the key role of localization in enhancing diversity in clinical trials

• Urgency vs. Diversity: the pressure for rapid trial results often leads to the exclusion of some diverse populations, in part due to the extensive localization efforts required
• Impact of localization: avoiding translation work can sideline certain participant groups, highlighting the need for improved translation strategies from sponsors, eCOA providers and translation vendors to enhance trial inclusivity
• Proactive solutions: adopting automation, integrating localization into technology development, and streamlining workflows for translation are essential for making clinical trials more inclusive and diverse

INTERACTIVE SESSION Get ready to actively participate and share your insights in this engaging, hands-on session

United for progress: AI and emerging technologies shaping the future

  • Upskilling and collaboration journey – how to stay on top of all emerging technologies
  • Use cases – where to begin and what is being done to integrate new technologies into clinical trials
  • Forward looking- what are the most promising ground-breaking technological advancements and innovations such as in silicon clinical trials?

Aspects to contemplate when selecting a CRO for rare disease trials

• Does possessing therapeutic expertise remain imperative in choosing a CRO for a rare disease inquiry?
• Evaluating the advantages of niche specialized CROs versus expansive multinational CROs
• Extra hurdles in the CRO selection procedure arise when addressing ultra-rare diseases, where CROs may lack familiarity with the condition
• Discussing the merits and drawbacks of engaging a comprehensive service CRO for your rare disease examination versus collaborating with various vendors across the study