OmniComm Systems, out of Florida, signed up a customer in Mountain View, California. Broncus Technologies will use OmniComm’s systems for both electronic data capture (EDC) and clinical trial management (CTM). “With TrialMaster, we have the ability to practically eliminate the data visibility gap that occurs with paper-based trials. Utilizing the capabilities of OmniComm’s EDC solution will enable Broncus to save time and money,” said Dov Gal, VP of Clinical Affairs of Broncus. “We selected the TrialMaster solution because of its ease of use and flexible structure. Its integrated platform will enable Broncus to save valuable time and provide control over critical trial processes.”

There is a new version of ClinTrace, Phase Forward’s tool for drug safety. The new version is tightly integrated with business intelligence software from Cognos and compliance with the online reporting requirements under the FDA’s 2001 MedWatch 3500A program.  That FDA program has a November, 2006, deadline but no clear path for FDA enforcement. Here’s what the people from Cognos said in the press release: “Cognos ReportNet provides a single authoring environment for creating reports to improve decision-making and increase business agility,” said Bill Stevens, senior director of life sciences solutions at Cognos. “Combining Cognos ReportNet with Clintrace adverse event tracking and reporting system represents a powerful solution that will enable Phase Forward customers to build their own reports without IT involvement.”

Microsoft announced pricing for its Vista operating system: from $200 to $400, depending on the type of license. Amazon had posted the prices early, without confirmation from Microsoft. Scheduled for wide release in January, 2007, the software is several years late. Most observers believe its shipping date could still slip further. Some early versions of Vista have been subjected to an unusual level of hostility from the Microsoft user community, which is worried about security bugs and other new features. Almost every new feature to make Windows more user-friendly—in photo editing, finding files, parental controls and other features—has been a familiar element of the Apple platform for several years.

PPD is touting its ability to let institutional review boards (IRBs) manage source documents and clinical trial events online. The company’s new GlobalView EventNet software is an electronic data capture solution but includes some clinical trial management functionality: The system is designed for all phases of research and registries. Here’s a release.

Mark McClellan stepped down as the administrator of the vast Medicare entitlement program. He sent an email to his staff that said, in part, “Many of you have heard me quote my grandfather: it’s not the dollars you make; it’s the difference you make.” It’s unclear whether McClellan was pushed or left on his own. He was blamed for glitches in the rollout of a prescription drug benefit to seniors, but generally credited with potentially transformative efforts to emphasize preventive care and save the government trillions. The physician-economist has not announced his next position, or the timetable for his departure. As head of the FDA, McClellan was generally respected by members of both political parties. But because of that post he is a target of a lawsuit over the delayed approval of the contraceptive Plan B.

Apotex, the large generic drug company, picked Sparta Systems’ Trackwise

software, which manages compliance data and work flow in the life sciences. “The vision of this system is to create an efficient, cost effective, global solution to track all required regulatory information pertaining to new products and product lifecycle management,” says Michael Davidson, CIO for Apotex. “Apotex selected TrackWise because it meets our functional requirements, and it provides our organization with a scalable and configurable web-based architecture, which has the ability to adapt and grow as our company’s needs evolve.”