Tuesday, October 27, 2009 06:54 AM
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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Monday, October 26, 2009 06:47 AM
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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Friday, October 23, 2009 07:13 AM
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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Thursday, October 22, 2009 07:16 AM
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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Thursday, October 22, 2009 06:09 AM
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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Wednesday, October 21, 2009 08:05 AM
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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Tuesday, October 20, 2009 08:01 AM
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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Monday, October 19, 2009 07:46 AM
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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Friday, October 16, 2009 08:11 AM
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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Thursday, October 15, 2009 07:44 AM
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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Wednesday, October 14, 2009 07:41 AM
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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Tuesday, October 13, 2009 06:42 AM
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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Monday, October 12, 2009 08:01 AM
Sarah Cannon Research Institute (SCRI) has signed an agreement with Redmond Regional Medical Center and The Harbin Clinic, a multi-specialty physician practice in Rome, Ga., to be a cardiovascular clinical research site in its network.
Last year, SCRI launched a cardiovascular research initiative to grow its network of cardiovascular sites. Redmond Regional Medical Center/The Harbin Clinic is SCRI’s second cardiovascular site and the first that includes both a hospital and a physician practice in the agreement.
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Friday, October 9, 2009 07:38 AM
StudyManager, a developer of integrated clinical trial management software (CTMS) and electronic data capture (EDC) solutions, recently expanded operations into China, resulting in sales of its sponsor edition product to two separate Chinese CROs.
StudyManager’s two newest customers are TigerMed and DMS-Pharma, both of which are established and successful CROs in China.
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Thursday, October 8, 2009 12:52 PM
Maryland-based contract research organization (CRO) United BioSource Corporation (UBC) received a $125-million growth equity from Berkshire Partners LLC, a Boston-based private equity firm, to support the company’s evidence-based acquisition and service offering expansion strategy.
Formed in 2003 by Ethan Leder and Mark Clein with $150 million in capital, UBC went on a CRO acquisition spree, rapidly growing to today’s 1,300 employees located in more than 20 countries.
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Thursday, October 8, 2009 08:46 AM
MDS Pharma Services’ early clinical research and clinical pharmacology operations in Belfast, Northern Ireland, and its clinical pharmacology and bioanalytical services operation in Lincoln, Nebraska, have been certified by Brazil’s regulatory agency, Agencia Nacional de Vigilancia Sanitaria (ANVISA).
“MDS Pharma Services is the only contract research organization in the UK, and one of only two in the U.S., to offer clients the benefits of ANVISA certification,” said MDS Pharma Services President David Spaight.
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Wednesday, October 7, 2009 07:49 AM
Quintiles launched a new web site, www.clinicalresearch.com, for those who have little or no understanding of clinical research.
“Research shows that 75% of the general public state they have little or no knowledge of clinical research and the participation process. We want to fundamentally change that statistic,” said Chris Cabell, head of Global Access to Patients at Quintiles.
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Tuesday, October 6, 2009 08:16 AM
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) issued the final version of the first major revision of its standards in its eight-year history.
AAHRPP streamlined the number of standards and increased flexibility in how to interpret them. It added or strengthened standards on global research, conflict of interest, community-based research, and data and safety monitoring.
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Monday, October 5, 2009 10:19 AM
The Changing Role of Clinical Data Manager
EDC technologies for data collection, along with growth in outsourcing data collection responsibilities to CROs and information technology companies, has dramatically changed the job expectations for clinical data managers.
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Monday, October 5, 2009 09:55 AM
Quintiles has boosted its capacity to support clinical trials across Europe by opening an expanded regional facility, including an 80,000-square-foot central laboratory, near Edinburgh, Scotland.
The facility, first announced in 2007, consolidates three buildings into a single complex, allowing space for more than 500 employees in the central laboratory and in clinical development services, including project management, regulatory affairs and data management.
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Monday, October 5, 2009 07:00 AM
By Martin Young, senior vice president, integration and product strategy at Phase Forward
In the evolution of software there often comes a point when an application’s original utility is no longer novel but has instead evolved to become the common method for performing the task it was designed to simplify.
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Friday, October 2, 2009 06:06 AM
BOSTON—China’s new investments in its domestic pharma industry are beginning to drive growth and reforms that are stimulating a new drug development culture, according to CenterWatch’s latest special report, China: A New Era of Innovation in Drug Development.
Scheduled for release in early October, the fifth report in CenterWatch’s clinical research series reveals the initial benefits of China’s efforts and the various reforms in progress, as well as a look at the further initiatives needed to make the country a major player in the drug development arena.
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Thursday, October 1, 2009 08:31 AM
Swiss contract research organization (CRO) TFS Trial Form Support has extended its partnership with Karolinska University Hospital in Sweden to 2016 and expanded the CRO’s early clinical research unit to 15,000 square feet and 30 overnight beds.
The partnership with Karolinska, which was first signed in 2003, led to the development of the early clinical development unit at Karolinska Trial Alliance.
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Wednesday, September 30, 2009 08:52 AM
James D. Thomasell, former acting president and CEO of the Association of Clinical Research Professionals (ACRP), has been named the new executive director of the association.
Thomasell serves as its primary resource for providing mission-focused leadership and global organizational management.
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Tuesday, September 29, 2009 08:40 AM
PPD recently opened a new central lab facility in Singapore, where the CRO has had an office for more than 10 years.
The new lab will expedite delivery of lab data, PPD said, reducing the cost of customized laboratory services for customers conducting work in southeast Asia.
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