SCOPE OF WORK

A Phase III clinical trial in the MENA region requiring Data Management.

THE CHALLENGE

The sponsor required Data Management services for a trial involving more than 1000 patients across 6 MENA region countries within a very short timeline.

THE CLINTEC APPROACH

With extremely short timelines and 50 sites located across 6 countries, ClinTec implemented electronic data capture (EDC) to circumvent shipping delays and further expedite the process. Implementation of EDC was the main challenge as most of the sites were naïve to the technology and required extensive training. ClinTec provided hands-on training to all sites prior to study start-up and a 24/7 technical support helpdesk throughout the study duration.  An efficient query-tracking system for resolution of discrepancies was also implemented. ClinTec’s Data Management team effectively resolved queries across all sites in less than 4 months to lock the database well within timelines.

THE OUTCOME

ClinTec successfully met the recruitment target within the aggressive timelines and coordinated the logistics of all samples for central analysis.