PPD appointed Neil McCullough as VP of quality management systems. He formerly worked at Pfizer. Commented David Grange, CEO of PPD: "Having led quality assurance initiatives for pharmaceutical companies for more than 20 years, Dr. McCullough brings exceptional leadership skills and quality expertise that enhance our ability to deliver for clients in today's changing drug development environment." Here's a release.

Kendle has a new chief marketing officer and senior VP. Recently working at i3 Global, where he was VP of business operations, Mark Roseman will replace Simon Higgonbotham and report directly to Candace Kendle. She said: "Mark brings to Kendle a wealth of operational experience and proven sales success in the CRO industry." Here's a release.

Medidata Solutions signed up another partner for its program for contract research organizations: PharmaNet. In a press release, Dalvir Gill, PharmaNet's president of late stage development, said: "From its ease-of-use and multilingual support to its double data entry and robust reporting for effective data analysis, [Medidata's electronic data capture system] Rave will effectively support the diverse group of investigators who participate in our studies.”

A British group will publish guidelines on patient-reported outcomes (PRO) in sleep disorders. The British Association for Psychopharmacology promises "an accessible yet up-to-date and evidence-based outline of the major issues, especially those relating to reliable diagnosis and appropriate treatment," according to a news article on Medscape.

CRF Health, a supplier of patient diary solutions, won certification from EXACT-PRO, a research consortium seeking to standardize patient-reported outcome research in chronic obstructive pulmonary disorder (COPD). The company said the certified handheld devices run on Windows Mobile. Separately, Bonnie Teschendorf has joined CRF as patient reported outcomes scientific advisor.

In a call to ban Avandia, GSK's diabetes blockbuster, editors at British Medical Journal present withering criticism. The journal comes close to accusing European and U.S. officials of incompetence and negligence. The authors criticize the usage of surrogate end points; bemoan regulators' tolerance of high numbers of patients who leave clinical trials; and mock the math used to defend the drug. "Sponsors, investigators, regulators and journal editors seem to have been content to accept truly dreadful standards of methodological quality," charges professor of clinical epidemiology Nick Freemantle at the University of Birmingham. "If the regulatory bodies do not insist on definite evidence of greater benefit than harm to patients, rather than changes in surrogate end points, they are failing in their basic purpose," write Richard Lehman and colleagues at Oxford and Yale. For now, GSK is not mounting an energetic defense of its data or its research methods, which are being reviewed by regulators on both sides of the Atlantic.

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