One investigative site’s bad fortune will become another site’s good as site management organization (SMO) Radiant Research closes its West Palm Beach, Fla., site, and Palm Beach Research Center takes on that site’s lead investigator along with an ongoing trial.

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Phase Forward’s fourth quarter revenues jumped 22% but profits went down, the company reported Thursday night. Phase Forward’s share price was down 26.7% to $10.88 in early morning trading.

The technology company’s Q4 revenues increased to $58.8 million, up from $48.3 million in the same quarter 2008. Net loss for the quarter was $68,000, or $0.00 per diluted share, compared with net income of $2.7 million, or $0.06 per diluted share, in the same period last year.

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New York-based contract research organization (CRO) Clinilabs released its own document management system that the company said will significantly reduce the cost of information management and clinical monitoring and auditing during clinical trials.

The CRO’s new system, Clinical InSite, complies with U.S. Food and Drug Administration regulations for managing clinical-trial workflow and enables Clinilabs to capture electronic files of any kind, store them in a central location in customized file formats and make them accessible to remote users in real time. The company said its system is significantly less expensive than other clinical trial document management systems.

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The U.S. Food and Drug Administration (FDA) recently released draft guidance for institutional review board (IRB) continuing review—the first updates that the regulatory agency has provided for this process since it issued IRB regulations in 1981. 

FDA’s original 1981 regulations were focused on single-site studies—the industry norm at the time—but, in recent years, multi-site studies have become standard and therefore require more oversight , according to the FDA.

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Quintiles has entered into a strategic alliance with Movetis to help sell the Belgium pharma company’s new gastrointestinal product.

The partnership calls for Quintiles to provide commercialization services, including sales support, market intelligence, consulting, regulatory and post-marketing pharmacovigilance in the U.K. and Germany.  The companies did not provide specific financial information about the agreement but said they plan to extend the partnership later this year to cover other European countries.

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Second Wave of Sponsor, CRO Growth Hitting Asia-Pac

A second wave of pharma is establishing R&D centers in China and top 10 pharmas are expanding their existing centers, spurring CROs to get busy not only in China but the entire Asia-Pac region.

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In an effort to speed up oncology trials in Latin America, PRA International  entered into a partnership agreement with Oncopartners, a Latin American oncology development company, and its exclusive partner IBPC, a non-profit oncology research network made up of Brazil’s largest public oncology hospitals.

Under the terms of the agreement, the organizations will align operational processes to accelerate the planning, recruitment and startup of oncology trials. PRA and Oncopartners will also exclusively market each others’ services in the pre-award phase of the studies.

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Covance reported fourth-quarter revenue growth of 11% to $507 million, largely due to the positive impact of foreign exchange.

The CRO’s revenues grew 8% in 2009. Year-end revenues were $1.96 billion in 2009 compared with $1.83 billion in 2008. Operating margin was 11.3%.  Earnings per share were $2.73 for the year and $0.64 per diluted share for the fourth quarter.

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As MDS continues its efforts to sell the rest of its contract research division, the company is preparing investors for less-than-expected earnings from that sale.

MDS, which sold its late-stage operations last year and still seeks a buyer for its early-stage business, plans to focus on MDS Nordion, the company’s medical imaging business. In its annual report published this week, MDS told investors that the sale of the early-stage business will likely garner lower sale proceeds than previously expected, due to “continued deterioration of market conditions, the declining early stage customer base and new developments in the ongoing strategic review process.”  

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PPD’s plan to refocus its contract research organization (CRO) business is one step closer to final with the recent sale of its biomarker services division, PPD Biomarker Discovery Sciences, to Montreal-based Caprion Proteomics.

Caprion purchased the shares and assets of the Menlo Park, Calif., business Dec. 31, 2009, for an undisclosed sum. With the sale of this portion of its business, PPD next plans to spin off its compound partnering business, creating two independent public companies. Only the CRO business will maintain the PPD name.

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