Duke University Medical Center: Digitizing clinical trials to boost efficiency and compliance

Introduction

Duke University Medical Center (DUMC), renowned for its groundbreaking HIV vaccine research, conducts critical immunogenicity testing on human clinical trial specimens. To maintain compliance with Good Clinical Laboratory Practice (GCLP) while managing an extensive number of standard operating procedures (SOPs) and audits, the Central Quality Assurance Unit (CQAU) needed a more efficient and reliable solution.

The challenge

The CQAU at DUMC faced considerable challenges with their existing paper-based processes: 

• Handling vast amounts of paperwork, including 300 SOPs and multiple audits, was labor-intensive and cumbersome.
• Maintaining paper records in Biosafety Level 3 Labs posed significant contamination risks, complicating compliance. 
• Reliance on paper-based audit checklists created a heavy administrative burden and increased the potential for errors.

Finding the right solution

DUMC sought a solution that could streamline their operations, reduce paperwork, and enhance compliance. They selected Ideagen Quality Management for its ability to: 

• Digitize documentation, providing mobile access to SOPs and eliminating the need for paper records.
• Automate audits, allowing staff to conduct audits electronically and improving efficiency.
• Enhance lab safety by reducing the use of paper in Biosafety Level 3 Labs, minimizing contamination risks.

Implementation and impact

The implementation brought significant improvements to DUMC’s clinical trials:

• Staff now access all SOPs on tablets, which improved efficiency and mobility across the board.
• Audits are now conducted without paper, reducing time spent on administrative tasks and ensuring accuracy.
• Digital records have minimized contamination risks, creating a safer and more compliant lab environment.