Funding difficulties have caused the sponsor of a large clinical trial to pull out of a contract with Parexel, which will negatively affect the CRO’s second quarter and full-year 2009 financial results.

Parexel has been running a large global phase III clinical trial for the client, an unnamed small biopharma company, since September 2007. 

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Cincinnati, Ohio-based Kendle is the latest contract research organization (CRO) to reduce its full year 2008 guidance as a result of the negative effect of foreign exchange rates.

The company now expects its 2008 net service revenues to be in the range of $475 million to $480 million, down from $485 million to $500 million. Kendle had already lowered the low-end of its full-year revenue guidance from $490 million in November.

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Research management organization Pharmatech is changing its name and focus to better reflect the company’s presence in the fast-growing oncology research market.

As of January 1, the Denver-based company is doing business as Pharmatech Oncology, a subsidiary of Pharmatech. Company executives hope this name change will distinguish the company’s core services from other contract research and site management organizations (CROs and SMOs).

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The Association of Clinical Research Professionals (ACRP) has expanded its online networking and educational resources. ACRP’s new online community, which launched Monday, includes an interactive member directory that allows members to create individualized profiles, groups and blogs; as well as an online encyclopedia (or Wiki), new eGroup options, and a searchable resource library, to which members can post documents and tools.

This new online service is a significant upgrade over ACRP’s previous online directory and listserv tools, which used somewhat outdated technology and software, according to ACRP marketing and communications director Jenna Rouse. The new system represents a global trend toward more interactive online networking and will hopefully provide valuable tools to members.

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Contract research organization (CRO) Bio-Imaging Technologies has sold off its CapMed division, which provides personal health management solutions to hospitals, employers and pharmaceutical companies, in order to better focus on the CRO’s core clinical trials business.

Under the terms of the agreement, Bio-Imaging will receive $500,000 in cash plus an earn-out over a two-year period from Metavante Technologies, a Milwaukee-based provider of banking and payment technologies.

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Japan’s Global Clinical Trials Initiations Skyrocket

New global clinical trial initiations increased dramatically from 2006 to 2007 in Japan. No other country in Asia experienced anywhere near such an increase in new global clinical trial initiations. Though Japan has made great strides at every level—government, site, sponsor, CRO and patient—to become more attractive for global clinical trial initiation, the country’s work is far from over. In fact, it is just beginning.

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Contract research organization (CRO) PPD has entered into a strategic collaboration with Merck that will significantly expand PPD’s global central laboratory business.

Under the terms of the agreement, PPD assumes control of Merck’s 130,000-square-foot vaccine testing laboratory and related equipment in Wayne, Pa., as well as 80 Merck employees who operate the facility.

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Global contract research organization (CRO) Covance ended the year with a flurry, lowering its 2008 guidance, purchasing an equity stake in a proteomics biomarker services provider and adding four executive positions.

The Princeton, N.J.-based company lowered its full-year 2008 guidance in late December, after experiencing a slower-than-expected fourth quarter. The CRO expects its full-year earnings per share to be $3.02 with “low double-digit” revenue growth, versus its previous full-year estimates of $3.18 per diluted share with 20% annual growth.

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Global contract research organization (CRO) Covance has added three new senior executive positions to its periapproval services team. The Princeton, N.J.-based company appointed Glynis Neagle, M.D., vice president for medical affairs; Robert Bader, director for product safety services; and Thomas Noto, vice president for regulatory affairs.

Neagle, who previously served as Covance’s senior director for clinical development, will oversee medical affairs, epidemiology and product safety.

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While the weakening economy has forced some drug companies to cancel or delay early phase projects, at least one company has seen a growing need for its niche phase I drug development services.

Dallas, Texas-based Metroplex Clinical Research Center (MCRC), which specializes in rheumatology studies, recently expanded its services to include phase I capabilities for clinical trials on patients. In the past year, the company has seen an increase in drug companies that want to conduct phase I studies on patients who are afflicted with different rheumatological diseases (e.g., rheumatoid arthritis, lupus and scleroderma) rather than healthy patients.

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The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited another 21 organizations in the fourth quarter, bringing its total number of accreditations this year to 67—more than any other single year since the association was founded in 2001.

AAHRPP, a non-profit organization that offers accreditation to organizations that conduct or review research with humans, has accredited 159 organizations representing more than 750 entities. The most recent list of accredited organizations includes two independent institutional review boards, a teaching hospital, a cancer center, a university and 16 Department of Veterans Affairs facilities. Earlier this year, the association accredited its first independent investigative research facility.

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A month after naming a new permanent CEO, beleaguered eClinical company etrials is reorganizing its management structure—a move that will result in the departure of once-interim CEO Chuck Piccirillo as well as two other senior executives.

This is the second major management restructuring for etrials in 2008. Earlier this year, the company lost its CEO, chief financial officer, and chief operating officer (whose position was eliminated).

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Troubled contract research organization (CRO) PharmaNet Development Group announced Thursday that it is working with a financial advisor from USB Investment Bank to explore strategic alternatives, including the potential sale of the company.

This move follows a year of struggles for the Princeton, N.J.-based CRO. Since the start of 2008, PharmaNet’s share price has plunged 97% from $39.19 in January to $1.01 in early morning trading Friday, and, in September, PharmaNet cut its full-year revenue forecast more than $30 million.

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Canadian life science company MDS, the parent company of King of Prussia, Pa.-based MDS Pharma Services, released fourth quarter results reflecting another disappointing quarter for its embattled contract research organization (CRO) division. Net revenues for MDS Pharma were $112 million, down 9% from the same quarter last year.

These financials come one month after a major shareholder pressured company leaders to sell off several business units including MDS Pharma in order to increase shareholder value. Earlier this month, MDS lowered its financial guidance for the third time this year.

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According to the August issue of The Centerwatch Monthly, the number of investigators in Central and Eastern Europe who filed Form FDA 1572s last year was close to 3,000, which means investigator participation in global clinical trials conducted in the region was up 25% over the prior year’s. Sponsors and global project managers from Western countries are managing teams and investigators from this region, and it is important for them to understand the specifics of this process.

As the CEO of Eastern Europe-based contract research organization OCT, Dmitry Shaikin recommends taking into account the following practical considerations to run a successful investigator meeting in Eastern Europe.

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UK-based contract research organization (CRO) Cmed has raised almost $10 million in growth capital—funds that will be used to advance the company’s electronic data capture (EDC) system and the company’s brand worldwide.

The funding, from European investment firm Scottish Equity Partners (SEP), comes as an investment in Cmed shares. Cmed will have access to further funds should the company need it, according to Cmed CEO David Connelly.

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The Association of Clinical Research Professionals (ACRP) has partnered with the Shanghai Clinical Research Center (SCRC) to promote ACRP training and certification throughout China.

SCRC will develop multiple ACRP-approved training centers in China, launch an annual national conference and facilitate ACRP Certification Examinations throughout China.  SCRC will also license its ready-made training course to ACRP.

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Global laboratory supply giant Thermo Fisher opened a new $17 million clinical services facility in Ahmedabad, India, giving the Waltham, Mass.-based company the largest Indian presence of any company in its industry, according to a company release.

The new 150,000-square-foot facility will support growing demand for biopharma services in the region and serve as a hub for packaging, distribution and logistics management of clinical trial supplies.

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One company’s bad luck became another’s good fortune with Clinsys Clinical Research’s recent acquisition of a new electronic data capture (EDC) platform, TrialStat ClinicalAnalytics (TrialStat CA).

Clinsys, a contract research organization (CRO) headquartered in Bedminster, N.J., was originally looking at TrialStat to be the CRO’s vendor for EDC software, but before the contracts or negotiations were finalized, Clinsys ended up owning the platform.

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Demand for Medical Writing Continues to Rise

According to CenterWatch analysis, the medical writing market has more than doubled in size during the past five years, increasing from an estimated $345 million in 2003 to $694 million in 2008.

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Although many companies are reducing headcount at an alarming rate, at least a few contract research organizations (CROs) continue to hire new people and create new positions. This week’s personnel news from around the clinical trial industry:

Portage, Mich.-based CRO Eurofins AvTech Laboratories named Jeff Moran director of business development in an effort to enhance client relations and expand AvTech’s bioanalytical reach. Moran has more than eight years of business development experience supporting both bioanalysis and phase I clinical trials.

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Chinese contract research organization (CRO) WuXi PharmaTech is discontinuing its U.S. biologics manufacturing operations as of December 31. As a result, the company will cut about 100 manufacturing and supporting positions at its Philadelphia facility.

“Given the depressed demand and the high cost structure of our biologics manufacturing services, we will focus on expanding our biologics testing, cell banking and cell therapy services in our Philadelphia site instead,” said WuXi CFO Benson Tsang in an investor conference call yesterday.

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Global Clinical Trials (GCT), a contract research organization (CRO) serving Eastern Europe and Russia, has expanded its St. Petersburg drug storage facility, a move that will enhance the CRO’s ability to manage trial logistics in that region.

CROs operating in Eastern Europe are not allowed to ship study materials from outside the country directly to research sites. Although most large CROs have their own internal logistics groups to handle these shipments, smaller CROs such as GCT usually rely on outside brokers to import and export trial supplies. These third-party arrangements can cause project delays and increase a study’s costs.

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Global contract research organization (CRO) Quintiles has acquired Westmont, Ill.-based Targeted Molecular Diagnostics (TMD), a specialty diagnostic laboratory focused on oncology.

The addition of TMD’s services will strengthen Quintiles’ capabilities in oncology, a fast-growing area for drug development.

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New York, NY-based contract research organization (CRO) Clinilabs appointed Howard Greenberg, M.D., senior medical director of the company’s newly expanded clinical pharmacology unit. Greenberg has served as the principal investigator or co-investigator for more than 100 clinical trials and co-authored more than 30 peer-reviewed research publications. Most recently, he was group medical director at Bristol-Meyers Squibb.

Other personnel news from the clinical trials industry:

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