The OpenClinica solution for electronic data capture (EDC) will be used in trials in Europe and Israel. Projects run by the Safe-T consortium—a €36 million effort which includes Amgen, Lilly, Novartis and Pfizer—will use the free EDC system to detect drug-induced safety issues. Said Ben Baumann, OpenClinica's director of business development: "They will only have to master one system, and they can build case report forms (CRF) and standard operating procedures (SOP) only once and then re-use them as necessary. This eliminates a lot of redundancy, while accelerating study start-up and ensuring higher quality trials.” The decision amounts to a rare big pharma endorsement of a less-expensive EDC alternative.

Parexel has arranged a five-year, $400 million revolving credit line from Bank of America, J.P. Morgan and other lenders. Here's an announcement.

Seth Jayson, an amateur investor on the Motley Fool website, says some short-selling Wall Street types are watching Covance. Jayson says there are interesting trends in the big contract research organization's (CRO) financial metrics for when sales are reported and actually received from customers.

Comparative effectiveness research (CER) should not become another political football. That's the view of Scott Gottlieb, a former official at FDA. In this essay for a conservative think tank in Washington, the pundit-physician says American politicians should resist pressure to spend heavily on CER trials comparing two drugs directly. Single-drug Phase II and III trials, he says, will keep drug safety signal detection cleaner and clearer. Gottlieb cites unnamed former FDA colleagues as advancing the same argument in years past. He predicts the question of how much to spend on CER will resurface during next year's debate over FDA user-fee legislation.

Generic drug manufacturers face no liability when they fail to display the black box drug safety warnings of chemically identical branded equivalent drugs. That's the gist of a recent U.S. Supreme Court drug safety decision. The high court tossed out a case brought by a Minnesota woman who had horrendous complications from long term usage of the anti-nausea drug metoclopramide (Reglan). Because the pharmacist gave her the generic version of the drug, she never saw any black box warning. The judges feel that state and federal law in the U.S. are contradicting each other. Differing state and federal rules, the court said, make it impossible for industry to comply with both sets of rules. Under the Constitution (but contrary to a similar "pre-emption" case against Wyeth) state law prevails. The case could help nudge forward federal legislation to clarify the question. This is a PDF document of the court's opinion. Here's an editorial in the Washington Post. For the public, there is no question that awareness of discrepancies between labels for branded and generic products will cast lawyers, the pharmaceutical industry and FDA in a bad light.

The FDA has a new draft guidance document. Some in vitro diagnostic tests and radiologic devices are being down-regulated because the agency thinks their safety is well established. "FDA intends to propose an amendment to the classification regulations to exempt these devices from 510(k) requirements that currently apply under the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act," the government says.

Icon bought Firecrest, a clinical trial management system (CTMS) designed to improve investigator site compliance. Both firms are based in Ireland. The purchase is another sign that some top-tier contract research organizations (CRO) feel obliged to own selected mission-critical trial systems, and not depend on those controlled by sponsors or partnering CROs. In a news release, Icon CEO Peter Gray said: “We have worked with Firecrest on a number of trials and have seen first hand how their technology improves quality through enhanced protocol compliance and drives efficiencies by reducing data queries and errors at sites. Our combined commitment to quality and our shared vision for using innovative technology to deliver more efficient and effective development programs make the companies a good fit.”

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