FDA head Margaret Hamburg has been worrying about the role of the life sciences in national security and research to thwart bioterror attacks. In truth, most of the federal money lavished on bioterrorism after 9/11 went into a black hole. But in a speech last week at Pittsburgh's medical school, Hamburg…more...

SAS has updated its JMP Clinical software. According to a press release, the new package "lets researchers look for patterns across all safety domains and identify similarities within subsets of subjects. Time windowing, also new, makes it easy to compare interventions, events and findings for two or more time periods. A…more...

West Coast Clinical Trials (WCCT), a contract research organization, selected OmniComm's system for electronic data capture (EDC). Jon Rojas, chief operating officer at WCCT, said he was happy to have found "a system that helps increase data quality, decrease costs and better meet the high demands of early phase development." Here's…more...

An article in PharmaTimes says a European think tank is concerned about the oversight of clinical trials in developing markets. One issue for the Dutch Center for Research on Multinational Corporations: the ambiguous regulatory role of contract research organizations (CROs) in an era of outsourcing. The think tank estimates that the…more...

All you have to do to find patients for clinical trials is advertise on Facebook and voila. Problem solved. That's the word from MediciGlobal. The company notes that for a recent trial that required adolescents and their mothers, the privacy violation social networking website found enough volunteers in less than six…more...

Safety experts at the Central Drugs Standard Control Organization in India have launched a pharmacovigilance program. But according to this blog post, they’ve not yet selected any drugs to analyze in depth. The new Indian system has already received approximately 5,000 spontaneous adverse events reports. Twelve regional offices are up and…more...

ERT has a video and blog article on suicidality monitoring. The video features an academic thought leader on the topic, psychiatrist John Greist of the University of Wisconsin and Healthcare Technology Systems. XML4Pharma, a German clinical trial software and consulting firm, announced a new version of its tool to map clinical…more...

Roche has been chastised about an ad featuring Sally Field. In the ad, she touts Boniva, the company's osteoporosis drug. "The print ad is misleading because it overstates the efficacy of Boniva," the FDA complains. The agency goes on to assert that Roche's claims are not warranted by clinical evidence. These…more...

Merck and Parexel inked a strategic, long-term collaboration for generic biotechnology products. The big contract research organization (CRO) will give Merck "strategic access to a broad range of regulatory strategy and clinical development planning capabilities for the development of certain broad classes of biosimilars across various therapeutic areas, including exclusivity for…more...

ERT awarded new titles to current chairman and chief scientific officer Joel Morganroth, designating him to be the firm's interim president and CEO while an executive search for the top post continues. A cardiologist by training, Morganroth spent a decade at FDA. This is a biography, but it's abbreviated. Sunesis launched…more...