2010

FDA Inspecting Few Overseas Sites

Thursday, July 8, 2010

More than three quarters of all clinical trial subjects were enrolled overseas, and yet the FDA inspected just 45 foreign investigative sites in 2008. That’s just 0.7% of all overseas sites that enrolled a trial subject.

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UBC Secures additional $150 million

Wednesday, July 7, 2010

United BioSource Corporation (UBC), a global scientific and medical affairs organization based in Bethesda, Md., has secured a new line of credit that provides the company with up to $150 million in additional financing for acquisitions and other significant growth investments. Wells Fargo, PNC Bank, Capital One and JPMorgan Chase participated in financing the new credit facility.

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Synexus Expands Operations in Poland

Wednesday, July 7, 2010

Synexus, an international recruiter and operator of clinical trials, is expanding its operations in Gdynia, Poland. It has also recently increased the capacity of its original center in Wroclaw. The new dedicated research center in Gdynia will have the capacity for four full-time investigators and will include a wide range of diagnostic instruments to cover Synexus’ expanding therapy area coverage. Dr. Radoslaw Janiak, Synexus Country Manager for Poland, said, “Being part of Synexus’ worldwide operations means that we are increasingly involved in large global clinical trials. We are able to recruit the right numbers of patients within the right time frame, and that’s exactly what sponsors are looking for. We are seeing considerable interest from a number of leading Pharmas and CROs who are keen on the developments we have under way to increase our capacity here.” Manchester, England-based Synexus has been operating in Poland since 2006 and expanded its operations there in 2009 when it acquired three new dedicated research centers in Warsaw, Gdynia and Katowice, following its takeover of CLCC.

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Doctor Sentenced to Six Months for Faking Study Results

Wednesday, July 7, 2010

Scott Reuben, the Massachusetts doctor dubbed the medical equivalent of Bernie Madoff by Scientific American, was sentenced to six months in federal prison on June 24. His crime: faking favorable painkiller study results. Reuben pleaded guilty to one count of health care fraud in February.

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PPD Named Best CRO in Asia

Thursday, July 1, 2010

PPD was named Best Contract Research Organization (CRO) in Asia at the World Vaccine Congress’ inaugural 2010 Vaccine Industry Excellence (ViE) Asia Awards held in Singapore.

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