Dallas-based Metroplex Clinical Research Center (MCRC) and Rheumatology Associates have opened their new 22,500-square-foot complex featuring rheumatology services and phase I-IV research services under one roof.

Founded in 1984 by rheumatologists Dr. Roy Fleischmann and Dr. Stanley Cohen, both the practice and MCRC have deep roots in North Texas.

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Kendle, a global contract research organization, reported third quarter net income slipped to $8.8 million or $0.59 per diluted share for the third quarter of 2009, compared with net income of $9.4 million or $0.62 per diluted share for the third quarter of 2008.  

The company said execution of cost control initiatives helped it maintain net income. Net revenues for the third quarter were $104.6 million, down slightly from the second quarter and off $20 million from the year ago quarter.

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Pennsylvania-based Omnicare Clinical Research, a global contract research organization (CRO), has opened an office in Seoul, South Korea.

“Since 2006, we have been conducting studies in South Korea with a local partner,” said Benoit Martin, president, International for Omnicare Clinical Research.

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Quintiles has entered into a strategic alliance with AstraZeneca. The contract research organization (CRO)-clinical pharmacology alliance with AstraZeneca was formed to deliver the sponsor’s clinical pharmacology studies across multiple therapy areas and around the globe.

Quintiles will assume the operational responsibilities for the majority of AstraZeneca’s clinical pharmacology delivery. The alliance involves a sole provider for clinical pharmacology delivery, and a simple, standardized pricing model.

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Cincinnati-based Schulman Associates IRB has expanded its institutional review board (IRB) services into Canada. For North American studies, which are conducted in both the U.S. and Canada, Canadian and U.S. board members will review the research together to maintain consistency.

“Our clients have asked us to provide review services in Canada.  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 John Isidor, Schulman’s CEO.

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How Investigative Sites Are Making it in Tough Times

During these difficult economic times, a number of investigative sites have been forced out of business or experienced severe cash crunches, squeezed by canceled projects, late payments from sponsors and tight study budgets. But sites are now seeing an uptick in studies as the year winds down, which they hope will continue into 2010.

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Signaling a major strategic shift, PPD is focusing on Asia-Pacific—China in particular. The company has made a big move in the region by entering into an agreement to acquire Excel PharmaStudies, one of the largest contract research organizations (CROs) in China, which will provide PPD additional capacity in China’s rapidly growing pharmaceutical market. PPD also plans to spin off its compound partnering business from its core CRO work and invest $100 million in Celtic Therapeutics.

The Excel PharmaStudies deal significantly increases PPD’s employee and client base in Asia-Pacific, the company said. Excel has about 370 employees and will operate as a wholly-owned subsidiary of PPD.  Financial terms of the deal were not disclosed.

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Waltham, Mass-based Phase Forward, a provider of data management solutions for clinical trials and drug safety, reported third quarter revenues jumped 24% to $53.1 million, compared with the third quarter of 2008, but earnings were cut in half.

For the third quarter, income from operations was $2.4 million, compared with $4.4 million in the third quarter of 2008. Net income for the period was $1.8 million, or $0.04 per diluted share, compared with $0.08 per diluted share in 2008.

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Raleigh, N.C.-based PRA International, a CRO, has opened a new office in Milan, Italy. PRA has operated in Italy since 2003 with home-based PRA staff.

 During the past three years, PRA has participated in more than 80 studies spanning 13 therapeutic areas in Italy.

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Phase Forward, a provider of data management solutions for clinical trials and drug safety, released its DefineValidator tool, Release 1.0, as a free download for Clinical Data Interchange Standards Consortium (CDISC) adopters.

The tool was adapted from a current feature of Phase Forward’s WebSDM product, which was developed under a Cooperative Research and Development Agreement (CRADA) for the U.S. Food and Drug Administration (FDA) to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format. 

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Laboratorio Hidalgo, a central laboratory in Buenos Aires, Argentina, has increased its capacity for its clinical trials division with a new facility five minutes from its headquarters and laboratory.

The two-story, 5,382-square-foot building enables the company to expand capacity for project and data management offices, documentation archive and kits manufacturing and logistics.

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PPD has entered into an agreement to acquire Excel PharmaStudies, one of the largest contract research organizations (CROs) in China, providing PPD additional capacity and expertise in the rapidly growing clinical research market.

The deal also significantly increases its employee and client base in Asia Pacific, the company said. Excel has more than 300 employees. Excel will operate as a wholly-owned subsidiary of PPD.

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Parexel's first quarter consolidated service revenue dipped 1.2% to $259.8 million, compared with $263 million in the prior year period. Net income also slipped to $12.4 million, or $0.21 per diluted share, compared with net income of $13.6 million, or $0.23 per diluted share, for the year ago quarter.

The contract research organization reported operating income of $18.5 million, or 7.1% of consolidated service revenue, in the first quarter of Fiscal Year 2010, compared with operating income of $22 million, or 8.4% of consolidated service revenue, in the comparable quarter of the prior year. Operating income in the prior year quarter would have been $17.2 million, or 6.7% of service revenue, when taking into account the $4.7 million net revenue and cost impact related to the previously described accounting adjustment.

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Berwyn, Pa.-based contract research organization (CRO) Encorium Group has terminated another deal to sell off part of the company. 

Instead, Encorium has completed a private placement of 3.94 million shares of its common stock with a private investor for an aggregate purchase price of $1.575 million, or $0.40 per share, after ending its previously announced negotiations to sell its subsidiary Encorium Oy to a U.S.-based CRO. 

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The Oncology R&D unit of GlaxoSmithKline (GSK) has entered into a new research alliance agreement with US Oncology, a nationwide cancer care company that supports a community-based research network specializing in phase I through IV oncology clinical trials. The non-exclusive collaboration is aimed at improving the execution time of GSK’s oncology clinical trials.

Under the agreement, scientists and oncologists within US Oncology will provide patient-oriented insight to clinical researchers at GSK, while US Oncology researchers will also have an opportunity to critique the design of future GSK cancer trials. The collective feedback will be used to better develop cancer trials that will directly address some of the most pressing patient needs.

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The Society for Clinical Data Management has awarded its annual Data Driven Innovation Award to Phase Forward for developing a technology that increased external data loading rates 100-fold.

The Data Driven Innovation Award recognizes the year’s best advancement in CDM technology or service resulting from a vendor-sponsor partnership.

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Covance, a global contract research organization, reported third quarter revenues grew 8% to $493.7 million compared with the prior year quarter, but operating income slipped 17% to $57.8 million.

The company reported earnings per diluted share of $0.79, including $0.09 per share gain related to the sale of its IVRS business and $0.03 cents from favorable income tax resolutions. Excluding the gain on sale and tax items in the quarter, earnings were $0.67 per diluted share.

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Dublin-based ICON, a global contract research organization (CRO), reported third quarter net income jumped 12% on sales that fell 2.3% to $220.3 million, compared with the year ago quarter.

Year-to-date, net revenues were $660.2 million, up 2.3% compared with the same period last year.

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World Courier has opened new investigational drug storage facilities in Melbourne, Australia, and Johannesburg, South Africa, bringing its network of GMP (Good Manufacturing Practice)-compliant clinical trial depots to a total of 11 worldwide.

“Together these two continents undertake over 15% of current global clinical trials conducted outside North America, representing an annual estimated market of almost U.S. $3 billion and a study frequency almost double that of China and India combined,” said Wayne Heyland, president and CEO of the World Courier group of companies.

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Omnicare appointed James Pusey as president and CEO of Omnicare Clinical Research. In his new position, Pusey will be responsible for Omnicare’s contract research organization (CRO) operations worldwide.

Pusey succeeds Dr. Dale B. Evans, who has resigned to pursue other opportunities. 

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Czura Thornton, the private investment group that already owns UK-based contract research organization (CRO) Chiltern International, has agreed to acquire the global central laboratory operations of MDS Pharma Services for about $8 million. 

The deal price could be worth up to $4 million more to MDS if the central laboratory achieves certain performance thresholds after the closing of the deal—which is expected to be completed in the fourth quarter. 

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Quintiles, the market-leading contract research organization (CRO) and Cerner, a global supplier of healthcare solutions and electronic health record (EHR) technology, signed an agreement that will provide biopharmaceutical sponsors with research and technology services for improving post-marketing research. 

Regulators and payers are increasingly calling for more post-marketing research, particularly observational studies and registries. CROs like Quintiles have been doing this type of research for some time and are looking to get a piece of the funding for comparative effectiveness research (CER). The American Recovery and Reinvestment Act, signed into law in February, includes $1.1 billion for CER. 

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Preclinical CRO Charles River Laboratories’ Shanghai facility received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), the Canadian Council on Animal Care (CCAC) and the Shanghai Laboratory Animal Commission (SLAC).

The AAALAC, CCAC and SLAC accreditations confirm Charles River’s ability to provide clients with superior service in a regulatory-compliant environment.

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Sage Bionetworks, a not-for-profit organization established to develop an open-access genomic platform for use in drug discovery, has received a major donation from Quintiles, a contract research organization (CRO).

The size of the donation was not disclosed. The Quintiles donation is a major part of Sage’s development efforts and will enable core research initiatives and the development of the innovative Sage Commons platform. 

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Phase Forward, a provider of data management solutions for clinical trials and drug safety, signed a multi-year agreement with Gedeon Richter, one of Central-Eastern Europe’s leading pharmaceutical companies with more than 10,000 employees worldwide.

Gedeon Richter plans to adopt Phase Forward’s Clintrial product for its clinical trial data management activities.

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