Why web-based Electronic Data Capture (EDC) is recommended for use in Phase I trials:

This information is not meant to provide a thorough presentation of the benefits of EDC, since such benefits have been widely publicized over the past several years as the technology has finally "come of age".

• Real-Time Access to the Data : All interested parties will have real time access to study data over the internet as it is generated. This allows for the monitoring of patient enrollments and related metrics, by site, at the earliest time point. This is useful in both the small and large clinical trials especially if working under relatively tight time lines. Enrollments need to be monitored very closely and corrective actions taken at the earliest opportunities. Built in system notifications can alert your medical monitor the second that an AE is created. Your clinical project manager can track the study remotely without ever traveling to the site.
• Faster Study Completion : TrialMaster saves time at the back-end of a study by precluding most of the time it takes for database "clean-up" in studies involving paper-based CRFs with fewer of your resources being utilized. That is because most incorrect or incomplete entries are automatically flagged at the time of entry and queries for non-automatic items can be handled shortly thereafter through electronic data review by the monitors. Given the deadlines for many clinical trials, which are getting tougher by the day, a savings of time for study closure is important. It is estimated that 3 to 4 weeks can be saved on the back-end, time which may be critical if there are any unanticipated future delays in either the commencement or conduct of the study.
• Cost Savings : EDC involves fixed upfront system development costs. The cost of TrialMaster is comparable to paper. The use of EDC can be even more cost effective when applied to multiple studies, which is relatively easy to do in certain therapeutic areas, in which there are a few primary indications and the studies are relatively simple and similar in terms of data captured. It is clear that the main cost is in system development. However, once the system has been developed, it can be highly leveraged.