Schulman Associates, a commercial institutional review board (IRB) is expanding its services into Canada and opening a Toronto office. The company will use its web-based system to manage documents for Canadian trials. "Now that our Canadian IRB is operational, Schulman can provide the same high quality review for Canadian research as it has provided in the U.S. for the past 26 years," said Schulman's CEO, John Isidor. The Cincinnati, Ohio firm is accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP), which ClinPage covered a while back.
Phase Forward reported sharply lower profits, with a 50 percent drop to $1.8 million, a rare interruption to years of steadily higher earnings. But revenue still rose, by 23 percent, to $53 million. The firm signed up a new customer, Bausch & Lomb, which vowed to run all new projects using the firm's electronic data capture system. And the Waltham, Mass. company is sitting on $147 million in cash. Here's a release.
GE lobbied the FDA to over-rule staff scientists and not single out its MRI contrast agent for renal adverse events. GE quietly persuaded the agency leaders to assign black box warnings to numerous contrast agents. GE maintains it has provided more data than competitors, and that that alone accounts for more insight into the safety issues for its product. Here are links to ProPublica and Business Week.
Case Western Reserve's medical center will lead a $15 million NIH trial. A team lead by Jackson Wright will guide the 9-year, 7,500-patient hypertension project. The study is part of the government's Clinical and Translational Science Awards (CTSA) initiative, in which top academic sites are being encouraged to reassert their scientific mojo. Here's a release.
Parexel reported flat revenues and profits for the quarter. Service revenue was $260 million, not the $263 million in the same period last year. Net income was $12.4 million, not the $13.6 million of a year ago. The company saw $100 million in cancellations but more than three times as much in new business. Said Josef von Rickenbach, chairman and CEO: “Despite a difficult market environment for both our industry and our company, we were able to exceed our earnings per share expectations. Client mergers and portfolio reprioritizations have created some unevenness in the demand for our services as reflected in project proposal flow and time to award." Here's the release.
ERT reported higher profits amid lower revenues. Net income rose 12 percent, to $2.8 million. Revenues dipped 6 percent, to $22.7 million. The company's annualized cancellation rate is now 20.1 percent, up from 16 percent earlier in the year. "The quarter was marked by growth in our routine (Phase I - IV) business, offset by a continued weakness in our thorough QT business," said Michael McKelvey, president and CEO. "We recorded a book to bill ratio of 1.9 in the quarter, the highest that ERT has ever recorded in recent history." Here's a release.
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