etrials Worldwide, Inc.

Dec. 13, 2006
Wireless Patient Diary Technology Optimizes Clinical Trials

The fully-integrated eDiary and interactive voice response (IVR) solutions offered by etrials Worldwide, Inc., a provider of eClinical software and services that optimize clinical-trial management and accelerate time-to-market, is being used in large global wireless studies.

eDiary is built on Microsoft's Windows mobile platform and captures patient-reported outcomes as they relate to the safety and tolerability of a drug. It manages and maintains patient enrollment as well as inventory management. The integrated etrials products all connect to a centralized server where comprehensive study data can be analyzed and reported for faster and more informed decision-making. Large scale trials can be deployed utilizing multiple solutions while rapidy integrating data into one central database.

eDiary is part of etrials’ clinical trial management system (CTMS), an Internet-based application that permits sharing of clinical trial information among office and home-based staff. It improves the efficiency and effectiveness of investigative studies by improving communication with investigative sites and project team staff regarding study start-up, conduct and close out, and corresponding documentation. A user-friendly application, CTMS offers a role-based security feature, limiting access to information depending on the user’s role in the organization or study. Data entered into CTMS can be accessed via standard and customizable reporting mechanisms. Custom integration is also available for seamless importing and exporting of data from and to CTMS.

The system enables users to document all site issues (such as protocol deviations, GCP deviations, etc.), as well as documenting all actions taken by staff members to resolve or address issues. It also serves to inform management about site issues and resolution progress and to ensure that significant issues are shared with the sponsor and IRB, if necessary, in a timely manner.