Dainippon Sumitomo chose the web-based version of the SAS Drug Development platform as an electronic repository for its regulatory data and documents. The drug development system handles both content management and analytical activities within the SAS environment. Here's a release.

Kika Clinical Solutions, an electronic data capture supplier, reported strong growth during the recent quarter. The privately held firm did not release any financial data, but claimed ten new trials and a new version of its system that includes a free-text area for communication between sites and monitors. Here's a release.

Omnicare Clinical Research has been accredited at the highest level on the electronic data capture (EDC) system from Medidata. Omnicare notes its 60 programmers set up approximately 100 EDC databases annually. "Our customers continue to view Medidata Rave as a critical component of the clinical development process and rely on the solution as a hub of clinical data," said Michael Burton, director of eclinical solutions at Omnicare. "The ASPire to Win program has been instrumental in allowing us to easily and efficiently meet our customers' needs for EDC at all phases of clinical trials." Here's a release

Pharsight released new software to simulate pharmacokinetics and pharmacodynamics. Phoenix Nonlinear Mixed Effects (NLME) replaces the firm's WinNonMix and is a tool for modeling, analyzing and simulating using libraries or custom-written code. "Phoenix NLME shortens the learning curve for drug development scientists to make initial use of population modeling methods, and also provides high-end functionality required by more advanced modelers," said Daniel Weiner, senior VP of Pharsight. Here's a release.

The pharmaceutical trade has long had a casual attitude to off-label promotion. Every major sponsor firm does it from time to time. Many major firms have paid hundreds of millions of dollars in fines. Wall Street looks the other way, knowing such penalties, while impressive in news headlines, are never sufficiently large to dent the perpetrator's annual revenue or stock price. So we were surprised to see the U.S. government had convicted a formerly well-regarded California biotech executive, Scott Harkonen, former CEO of Intermune. The charge: wire fraud. The case hinged on a news release with a few not-entirely truthful statements about a clinical trial. The trial, alas, failed. The news release was a spectacular success. We're certain Dr. Harkonen's attorneys will keep him out of a locked country club where he might be obliged to play mah jong for a while. But in a tight job market, a conviction could be a delicate matter to add to a C.V. Does your rap sheet go before or after the MBA from the University of California, Berkeley? "Pharmaceutical executives will not be able to hide behind a corporate shield when they promote drugs using false or fraudulent information,” vowed Thomas Doyle, special agent in charge of the FDA’s office of criminal investigations. Would the FDA really pursue executives at more politically-connected firms? Here's a story and a press release.

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