eClinical

Estimates suggest that biopharmaceutical companies spend more than $150 million per year on data exchange. The industry needs to work smarter, faster, and with fewer resources.

A technological look at yesterday and today could predict tomorrow's trends.

Paper-free clinical trials may not ever happen-but many of its advantages are already available.

For all the promises of the impact of technology on clinical trials-from enhanced trial efficiencies to reduced time to market-very few specific examples have been published that clearly demonstrate a marked impact. This article provides just such an example, by examining the impact of electronic diaries (eDiaries) on the collection of Patient Reported Outcome (PRO) data in a large, pivotal Phase III trial evaluating a medication for the treatment of overactive bladder (OAB). We compare the results obtained using eDiaries to capture real-time data on voluntary and involuntary micturitions with those obtained from a Phase II trial that used paper diaries. The result: measurable subject protocol compliance and significantly reduced error variance, yielding increased study sensitivity and the opportunity to realize a significant financial savings in future trials.

One new idea that?s ready for use; another that will be soon; and a third that?s not yet there.

Two of the latest concepts in computing are new twists on old ideas?which could be the eventual path for clinical trials data processing.

Web services and the concept of technology integration are hot new trends that may have a major impact on the way we do business and manage data.

Paul Bleicher shares his regulatory philosophy and perspective and defends his position regarding eSource, in response to June?s Guest Commentary.

Take a tour through the world of freeware, shareware, shrink-wrapped, enterprise, and open source software.

Making electronic CRFs friendly to both investigators and reviewers is a challenge.