CRF Health, a patient diary firm, announced that its hardware can now be wirelessly connected to spirometers and glucometers, specialized devices that measure lung function and blood sugars. “CRF Health’s ediary TrialMax platform now integrates with Entra Health Systems’ Bluetooth-enabled MyGlucoHealth wireless meter and Vitalograph’s Asma-1 electronic peak flow meter,” the company said in a release.

ClearTrial released a new version of its web-based trial budgeting application. For the first time, the Chicago firm is publishing its application programming interface (API), which allows the firm’s analytic software and data to be used in any web service-based system, “which encompasses virtually all of the eclinical, financial, resource management, and business intelligence systems in use by biopharmaceutical and medical device companies today,” the company noted in a press release. Said Andrew Grygiel, VP of marketing and product management: "The new web services API makes the integration and interoperability of ClearTrial with their existing systems even faster and easier than before." In the autumn of 2010, we wrote a series of articles on clinical trial optimization mentioning the firm's software, one of which is here.

U.S. politicians are maneuvering to find ways to nudge the FDA to loosen decisions and enforcement around Good Manufacturing Practices. The problem: perceived drug shortages. That's the gist of an article by a pro-industry Bloomberg journalist, who suggests the agency is indirectly at fault for overly strict oversight of drugs that predate its 1938 creation. Here’s an editorial.

Can clinical data standards be, God help us, fun? The work of the Clinical Data Interchange Standards Consortium (CDISC) can be a bit esoteric. But yesterday on the exhibit floor at the 2011 Drug Information Association annual meeting, we saw a demonstration of the power of what CDISC can do in the drug safety arena. The software was JMP Clinical from SAS. Presenting what happens to patients over time, the program can handle stunningly attractive, animated visualizations of adverse events. Subgroups of patients, organ systems and time intervals can all be easily selected or deselected to focus on suspected effects of a drug. In a few seconds, the software can analyze and display hundreds of paper pages of data or thousands of records. One term for the graphic is “exploding volcano,” but it resembles a bubble chart that moves. This stuff is not just eye candy. SAS says FDA reviewers are rigorously trained on JMP and comfortable with the software. Don't even try to do this in Microsoft Excel. CDISC data are required.

Medidata Solutions announced a new trial reporting system with preloaded metrics. The goal: to use operational data already in electronic data capture (EDC) and other systems to quickly create dynamic, interactive reports and charts. That will let managers easily see how a trial or group of trials is progressing. The module will run in a web browser and be called “Insights.” According to the Manhattan firm, it “offers immediate access to hundreds of metrics across critical operational areas, such as site enrollment, data quality and electronic case report form (eCRF) design, alongside industry benchmarks based on data from thousands of current and historical clinical trials.” Here’s a release.

• Medidata also said it will buy Clinical Force, a clinical trial management system company based in Britain. Terms were not disclosed; it’s not clear yet if the transaction is significant enough to require the disclosure of its price. Medidata is not the first technology firm to buy a clinical trial management system (CTMS), with half a dozen large and small rivals already having done so. But with other parts of its platform, including trial protocol authoring and database-setup engines, Medidata may be able to do more with a CTMS than competitors. Here’s a release and a previous ClinPage article on Clinical Force, which had especially strong functionality in the investigator-payments area.

Icon announced a new system that offers a unified view of all major systems of a clinical trial. Called Iconik, the software consolidates and normalizes data from EDC, sites, randomization and diaries, among other sources. There are also new reporting and data visualization tools. “Iconik provides immediate knowledge to study teams by allowing near real-time access to study performance metrics, critical safety and efficacy data, and analysis of this data in new and unique ways,” the company said. Depending on how easy to use the system turns out to be, it could put further distance between Icon and less tech-savvy contract research organizations (CRO) that are only starting to explore complex data integration tasks.

We’ll have more DIA news later in the week. Send it to .(JavaScript must be enabled to view this email address)

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