Data Management

lient: Diagnostic and imaging company conducting a multi-center comparative study

Situation

New team lacking the internal capabilities and resources to successfully run the trial on their own. With limited clinical staff, the company assembled a team of experts from different companies. Monitors, statistical, and data management functions were outsourced.

Solution

• A fax infrastructure was established so that CRFs could be sent directly from the site to data management in close to real-time of patient visits.
  
  
• Faxed CRFs were processed into the data management system for pre-monitoring review and cleansing.
  
  
• Dyad conducted weekly status meetings with the sponsor to discuss trial strategy, site enrollment, data management issues, plan monitoring visits, and determine appropriate trial course corrections.
  
  
• Data was queried and weekly progress reports were sent to sites and monitors along with requests for clarification and to resolve discrepancies.
  
  
• Monitors were able to plan visits with electronic access to CRFs pages and listings of outstanding discrepancies.

Benefits

• Data cleansing performed prior to monitoring visits - allowed monitoring visits to be more productive and less error-prone.
  
  
• Dyad caught and reported site errors within hours of first patient enrolled allowing immediate feedback and training to occur, reducing the ripple effect of compounding data errors.
  
  
• Tight integration between sponsor, monitors, data management, and site coordinators allowing database to be closed and locked within 10 days of last patient visit.