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White Papers
Industry White Papers
From best practices in EDC, to helpful data management tips, these white papers will help you learn from the success of others, and provide valuable insight to conduct your own trials better. Please register to read our white papers.
Data Management Strategies
Electronic Data Capture (EDC) systems should be more than just a means to an end. Quality EDC systems can enable the entire clinical trials information management process. Your diligence in implementing thorough preparation—including edit check specifications and standardized eCRF design—will improve the efficiency of your study, and help you avoid some of the most common pitfalls even an experienced data manager can encounter.
Full Service EDC as an Alternative to Outsourcing
Companies find remarkable results are a feature of how they capture and monitor clinical data during clinical trials; especially when they implement electronic data capture. Most sponsors describe their use of CROs as a strategic, rather than a tactical decision. However, most sponsors also view CROs as considerably more expensive than in-house resources. Does EDC actually allow a sponsor to do anything they just can’t do with paper?
FDA Response to AEs
In the wake of the recent spate of drug withdrawals and other drug safety issues, there have been renewed calls to reform and enhance the U.S. approach to monitoring safety issues in marketed products. These calls have come from many quarters, and a variety of initiatives have been the result.
EDC in Oncology Studies
Functional challenges aside, electronic data capture can improve cancer clinical trials. EDC in oncology has a number of functional challenges that must be addressed in order to fully utilize its potential. Among these challenges are study design issues, capturing measures of study efficacy, study safety monitoring, and the management of study logistics. This white paper focuses on the opportunities to ease some of the issues by using EDC.
Comments (1) | See more...
wenker@chpnet.org, 11/30/2009:
Can't download your paper. Interested in EDC for our GI cancer system.
Can't download your paper. Interested in EDC for our GI cancer system.
The Business Case for Outsourcing EDC
This white paper is intended for clinical operations managers who are either considering their electronic data capture (EDC) options for the first time or re-evaluating previous decisions. This paper looks at the primary approaches for acquiring, implementing and applying eClinical technologies with a particular focus on choosing the approach that best matches your organization’s goals and capabilities.
The 8 Secrets of EDC
The promise of Electronic Data Capture to improve the speed and quality of clinical trials is too great to be ignored. These eight “secrets to success” will help you understand how to fulfill that promise — and gain the full advantage of EDC. Review the eight steps.
Medical Imaging and Electronic Data Capture in Clinical Trials: The Future Paradigm
All clinical trial data are ultimately digital. The pathway to this digital database is not always as connected as one might expect in this technological age. The backbone of clinical trials is now Electronic Data Capture (EDC), and this is not yet synchronous with the other major aspects of data collection, such as medical imaging. With the need for more streamlined processes, this paper explores the combination of medical imaging with EDC and provides the future paradigm for the trial list in the digital age.
This is a a great white paper!