Quality Data...Delivered by Design™

Quality Data...Delivered by Design™


Integrating Trial Data Processes Across Functional Areas using Electronic Data Capture (EDC) Technology

A joint effort with Datatrak

One common theme in the pharmaceutical, biotechnology and medical device industry is the constant pressure to accelerate development of drugs, biologics and products to market. Improvements usually tend to focus on one aspect of the development workflow at a time. One of the processes that is the most time and effort intensive is data collection and management. Clinical data workflows have traditionally been tweaked especially with the growing acceptance of new technology and more contemporary enterprise eclinical applications (those applications that include clinical trial management systems (CTMS), electronic data capture (EDC), randomization and drug supply, etc.). Today many companies are viewing procedures not only within but across functional areas as a necessity to streamline data flow and the development process. This white paper will describe some of the process re-engineering, role modification or definition, enhanced communication and project coordination improvements needed to implement the use of an EDC application across the functional areas of clinical monitoring, project management, Investigator sites, and clinical data management (CDM) so companies can maximize the benefits of today’s technology.

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Achieving Cost Savings using EDC Effectively


As with many new technologies that dramatically change the way we work, the use of EDC to collect data during clinical trials still has its challenges. Challenges to proper implementation include poor early experience with EDC, corporate SOPs, department structures with a comfortable reliance on paper data collection methods, concern about data safety and integrity, and others.

Increasing costs and timelines for clinical development are forcing pharmaceutical companies to reduce costs and improve trial quality. Biotech companies, limited in funds, are looking for the same opportunities to reduce cost while increasing data quality. However, the inappropriate use of this technology and the lack of business process reengineering to implement the technology properly have resulted in the expectation and, in some cases reality, that EDC is more expensive than traditional paper trials.

This paper provides the logical and financial support for the cost savings and increased trial quality found with the use of EDC in Clinical Trials.

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