QUMAS, a provider of quality management and regulatory affairs solutions, announced that PharmaMar has selected QUMAS DocCompliance as its regulatory content management system. PharmaMar now has a single solution that enables it electronically create, manage and securely store all necessary content. It will manage reports and records related to bringing pharmaceutical drugs to market. Ken Hayward, executive vice president for QUMAS, said: “PharmaMar can deploy a solution that helps them operate in a continuous state of compliance at all times, even as new regulations come to the forefront.”

The Institute for OneWorld Health, a U.S.-based non-profit pharmaceutical company that develops drugs for people with infectious diseases in the developing world, announced the initiation of a major Phase IV pharmacovigilance and access program of Paromomycin IM Injection for visceral leishmaniasis (VL) in India. Partners include Odyssey Research for clinical research management; Synteract for data analysis; and Voxiva for a data management system. Ahvie Herskowitz, OneWorld Health’s co-founder and chief medical officer, said: “Our ongoing research results underscore the potential of Paromomycin IM Injection to treat VL—and save lives—at very low cost and in safe and practical ways.”

Holmes Biopharma, a contract research organization, announced its first quarter of profitability for the quarter ending September 30, 2007. The company expects revenue to grow and profits to increase going forward to the year-end December 31, 2007, and into 2008. It is also in the process of securing financing for another clinical research facility in the U.S. and start its drug development strategy. 

The FDA and the Duke University Medical Center have collaborated to modernize clinical trails. Duke will host a Public-Private Partnership that will include broad representation from government, industry, patient advocacy groups, professional societies, and academia. Robert M. Califf, vice chancellor for clinical research at Duke University, said:  “Our system of clinical trials provides the evidence for what the FDA approves and which medical practices are adopted as professional standards. We aim to provide a forum in which the experts in the field can put forward ideas about how to improve the system and then we can do research to inform policy makers about whether suggested changes are likely to have beneficial effects.”

There is another drug safety collaboration. The sponsors who are involved include Lilly, JNJ and Pfizer. “The collaboration will be working with the FDA to create an active drug safety surveillance system in the United States, which is a key provision of the recent FDA Amendments Act (FDAAA) of 2007,” says this article.

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