Public Citizen, a pro-public lobbying group, has a track record of identifying drug safety issues years before they reach the boiling point at regulatory agencies. The group has just reissued a 1998 call for a ban of gloves with cornstarch powder or latex rubber, citing allergies that can affect patients and care providers. “The FDA’s prolonged failure to take action eliminating the dangers posed by powdered surgical and patient examination gloves demonstrates a reckless and inexcusable disregard for the health and safety of patients and health care workers,” said Michael Carome, deputy director of Public Citizen’s Health Research Group. Here's a ClinPage story on the organization.
In the midst of $40 billion in federal subsidies to help IT-challenged U.S. physicians buy computers, it's a relief to learn that one of the most disadvantaged medical specialties, radiology, has not been overlooked. The name for this vital program: "meaningful use." Here's a news release. One worry is what underprivileged radiologists in Appalachia or inner-city locations will do if the money runs out before they can grab it. If additional federal philanthropy is not available, let's hope the Red Cross or Doctors Without Borders will step in.
Oracle announced a new version of its software for clinical trials. The company appears to be meeting greater demand for data integration between its own products and those of other technology firms. Oracle says it is now offering "prebuilt" modules to collect data not only from its own electronic data capture (EDC) systems, but also from arch-rival Medidata. "The release provides new integration, increased automation, and expanded data standardization to enable accelerated processing of clinical trial data from multiple sources in a variety of formats and increased user productivity from capture through submission," the company said.
DZS Software announced enhancements to its tools for clinical data management. The improvements to its ClinPlus report system include ways to convert data and metadata into the formats developed by the Clinical Data Interchange Standards Consortium (CDISC). This gets a bit technical. But DZS says its "ADaM Data Conversion and Reporting Toolkit [is] an elegant solution for both metadata-driven conversion of SDTM data to ADaM data and the production of metadata-driven flexible safety tables and listings from the ADaM data. The metadata, defined in Microsoft Excel spreadsheets, becomes the ADaM documentation, thereby eliminating any chance that documentation does not correspond to the actual process," according to a release on this page.
PPD reported robust quarterly financial results that may herald a potential turnaround for the contract research industry. Service revenue at the Wilmington, North Carolina firm rose 10 percent, to $356 million. Profits rose 104 percent, to $37 million. "We were pleased to deliver solid gross and net authorizations in the first quarter of 2011," said David Grange, CEO. "Clinical development services segment margins remained strong for the quarter, while laboratory services segment results were impacted by higher than normal project cancellations and postponements, and increased investment in research and development to support the future growth of our drug discovery services business." Here's the release.
We'd been wondering about what happened to Averion. It turns out it's been one of several firms rolled into a new, larger contract research organization, Aptiv Solutions. Other member companies include: Treo Clinical Research, Fulcrum Pharma, ClinResearch, Addplan and Niphix. The CRO doesn't yet identify the geographical location of its main headquarters, as far as we can tell. But earlier this month, it announced a new center for adaptive designs—the firm's specialty. "Our goal at Aptiv Solutions is to be the leading provider of adaptive design and execution services worldwide," Patrick Donnelly, CEO says in a video greeting. The firm is planning formal announcements of its existence at upcoming trade shows.
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