Case Study

How To Successfully Transfer A Rescue Clinical Trial

Source: Chiltern
  • This was a rescue study with challenging milestones and recruitment timelines.
  • Ensuring the appropriate transfer of agreements with sites.
  • Timelines for lifting of high volume of patient diary cards and questionnaires to meet the sponsor’s internal review timelines were extremely challenging due to end-loaded recruitment.
  • Alignment of sponsor and Chiltern SOP requirements for SAE reporting.
  • Technical issues with access to the sponsor database systems.
  • Management and monitoring of sites to ensure continued motivation of study staff throughout study duration.
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