Lilly lauded specialized contract research organization i3 Global with a supplier of the year award. Said Gregg Dearhammer, president of i3 Statprobe, “We align our goals with those of our customers and foster a do-it-right-the-first-time culture to ensure reliability, on-time delivery and a proactive approach to helping our customers improve productivity and reduce cost."
ClinTec, a contract research organization with headquarters in Scotland, appointed Austin Clark as director of global clinical resourcing. He previously worked at Adecco, holding various sales and marketing positions.
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There are two National Cancer Institute trials using adaptive designs, according to this article. But even the key participants are not sure how widely the approach can be used. “This type of trial model is highly dependent on having good biomarkers and good treatments both of which are severely lacking for patients with advanced disease,” says oncologist Edward Kim of the M.D. Anderson Cancer Center.
There has not been a lot of news out of the Critical Path Institute. But the U.S. authorities have apparently agreed that several new biomarkers for kidney function are validated. "The FDA and EMA reached the formal conclusion that the biomarkers are considered qualified for use in regulatory decision-making for drug safety to detect acute drug-induced kidney injury in preclinical studies and, on a case by case basis after discussion with agencies, in early clinical studies in combination with standard biomarkers," the release says.
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Medidata Solutions and Aris Global announced an integration of their solutions for electronic data capture and drug safety. “By instantly transferring safety-related data from the Medidata Rave EDC system to the ARISg safety reporting system, this solution helps eliminate duplicative entry, reduce SAE reconciliation efforts and chances for errors and expedite reporting time,” the companies said in the release.
Separately, Medidata reported quarterly financial results. Revenue rose 12 percent, to $37.6 million, but professional services dropped 20 percent to $7.9 million. Profits rose 10 percent to $1.8 million. The company said it added 38 customers during the previous 12 months, for a total of 192 clients. Revenues in Europe and Asia are growing at three times the rate of sponsors in North America.
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