Pharmanet

Client:

A global pharmaceutical company conducting a large, Phase III study that required close monitoring of safety data, accelerated collection and querying of patient data, and expedited database closure at study completion.

Challenge:

Although electronic data capture (EDC) was the ideal tool for this client’s needs, approximately 20% of participating sites–including key opinion leaders and sites that were expected to have high enrollments–were either unable or unwilling to use EDC.

Solution:

The study used PharmaSoft to acquire data from four sources:

Site-based single data entry (SDE)

In-house double data entry (DDE)

Faxed/scanned data from paper CRFs

Paper CRFs retrieved and entered in-house

All data, regardless of entry method, resided in a single database and were reviewed and managed centrally.

Outcome:

PharmaSoft enabled sites to enter data by their preferred method. PharmaSoft provided the study Medical Monitors with timely, online access to key safety and efficacy information, available for display as both electronic CRFs and patient case books. And, PharmaSoft reduced the time required for database closure by 50%, compared to a traditional study using paper CRFs.