Imperial Clinical Trials Unit Dramatically Accelerates Medical Product Trials by Using Electronic Data Collection
 
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Imperial Clinical Trials Unit Dramatically Accelerates Medical Product Trials by Using Electronic Data Collection

Established in 2010, The Imperial Clinical Trials Unit (ICTU) is a research unit working across Imperial College London and Imperial College Healthcare National Health Service (NHS) Trust. Together with the Royal Brompton and Harefield NHS Foundation Trust and affiliated NHS trusts, the ICTU delivers world-class clinical trials. ICTU is part of the United Kingdom’s first Academic Health Sciences Centre (AHSC) and plays a pivotal role in helping the center to achieve its goal of becoming one of the world’s top centers for research and healthcare delivery.

ICTU implemented Oracle Health Sciences InForm to eliminate paper-based clinical data management systems and improve clinical trial efficiency while ensuring regulatory compliance. The use of the library function has assisted the team by re-using prewritten and tested forms.

 
 

 
 

Challenges

  • Implement an electronic data collection system to execute world-class clinical trials as required by a global, academic customer base
  • Replace manual and paper-based tools for capturing and managing patient data to improve efficiency and reduce costs
  • Ensure compliance with legal and regulatory requirements governing clinical trials
  • Standardize clinical trial design with written standard operating procedures to ensure compliance and accelerate future trial deployments

Solutions

  • Accelerated typical clinical trial set up from approximately 22 weeks to 16 weeks with re-use or amendment of existing forms― and completed one trial in just 5 weeks
  • Gained repeat customers across a wider range of therapeutic areas, including cancer and HIV drug research, with an industry-respected electronic data collection system, faster trial set-up, and improved access to interim reporting during trials
  • Standardized and streamlined clinical trial design with Oracle Health Sciences Central Designer, accelerating trial set-up times, reducing design costs, and gaining the ability to efficiently and accurately replicate trials
  • Replaced paper-based data capture and paper audit trail with electronic data collection and validation system to improve efficiency and reduce costs
  • Improved monitoring and reporting effectiveness during the trial process, enabling trial managers and sponsors to analyze interim results to assess study progress and treatment efficacy
  • Facilitated compliance with regulatory requirements with a fully compliant and validated clinical trial and data management system