Archives: Agenda

Site selection for increased patient recruitment and retention

  • Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies
  • Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies
  • Showcasing how patient accrual has been affected in clinical trials utilizing virtual components

Critical to quality factors: a simple but powerful framework for risk-based quality management

The Quality by Design (QbD) and Critical to Quality (CTQ) Factor concepts were introduced by the Clinical Trials Transformation Initiative (CTTI) in 2015 and included in ICH E8(R1) (General Considerations for Clinical Trials) in 2021.  The current draft of ICH E6(R3) integrates the QbD and CTQ Factor concepts with RBQM.  Despite Health Authority and Industry endorsement and support, Sponsors and CROs aren’t taking full advantage of CTQ Factors in the clinical trial process. This presentation will explain how a CTQ Framework can be implemented simply and flexibly – to align RBQM activities from the protocol to the risk assessment to the operationalization of mitigation activities in the functional plans and more. 

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

Innovations in patient recruitment, powered by AI

  • Understand how AI is revolutionizing how content is rated and qualified by enhancing precision and accelerating the speed of communication
  • Experience a real-life AI application used to optimize patient recruitment materials
  • Gain insights into future trends and opportunities in AI-powered translation for the life sciences sector, including regulatory compliance for labeling