ClearTrial, a provider of clinical trial software, appointed Michael Bruns as the company’s new chief operating officer. Bruns will oversee ClearTrial’s global operations and help further develop and implement the company’s growth strategy. Prior to joining ClearTrial, Bruns was director of the Technology Investment Banking Group at Robert W. Baird, a global investment banking firm.

Other personnel news from the clinical trial industry:

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Chinese contract research organization (CRO) WuXi Pharmatech reported an 87% increase in 2008 revenues compared with 2007, with net revenues for continuing operations of $253.5 million. Fourth-quarter 2008 net revenues from continuing operations increased 74% to $64.4 million compared with fourth quarter 2007. The CRO’s non-GAAP net income for 2008 was $58.3 million, up 31% from $44.6 million in 2007.

WuXi’s 2008 financials reflect the January 2008 acquisition of AppTec, which contributed $57.7 million in revenues for full-year 2008.

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Business software company Oracle has agreed to acquire Relsys, a provider of drug safety and risk management applications, for an undisclosed amount. The deal is expected to close by summer.

Relsys, which supports adverse event reporting, risk management and data analysis for drug and medical device developers and contract research organizations, will becomes a part of Oracle’s Health Sciences Global Business Unit.

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Covance has expanded its clinical pharmacology presence in Europe with the recent acquisition of Swiss Pharma Contract, a contract research organization (CRO) in Basel, Switzerland, for an undisclosed sum.

Covance has offered clinical pharmacology services in Europe for more than 20 years through a facility in Leeds, England. However, the Swiss Pharma facility will be the company’s first foray into clinical pharmacology in Switzerland.

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Source: Coast IRB

In a press release issued on March 10, 2009, Coast Independent Review Board informed the public that it had discovered what appeared to be a fraudulent clinical trial submitted to that Independent review board for evaluation. Coast IRB has since learned that the fraudulent trial was apparently commenced as part of a congressional “sting” operation. Apparently at the behest of the U.S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs to induce them to perform reviews. Evidence of the progress of the trials could then form the basis for arguments critical of FDA and in favor of greater regulatory oversight. Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.

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Dr. Michael McKelvey, CEO of ERT , a leading provider of centralized ECG and eClinical technology, ePRO, and other services to the biopharmaceutical, medical device, and related industries, discusses the benefits of electronic patient reported outcomes (ePRO) tools for assessing and monitoring suicidality in clinical drug trials.

Over the years, there has been increasing concern regarding suicidal ideation and behaviors in patients taking medications. Pharmaceutical drugs can influence chemicals that enter the brain and affect emotions, thoughts and behaviors. It has been shown that even medicines used to treat diverse indications, such as acne, asthma and insomnia, may affect or even cause suicidal tendencies.

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Late last year may not have seemed like the best time to launch a new business but that’s exactly what Randy Spaulding did when he opened the doors to Spaulding Clinical in West Bend, Wisc., in August.

The phase I clinical testing facility took on its first study three days after opening, and now, seven months later, the company has four studies in the works and 20 full-time employees.

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Contract research organization (CRO) i3 launched a new web-based clinical trial and data management program that will replace the need for multiple systems and applications to manage study activities.

The new technology, i3Cube, centralizes study information into a single location throughout the entire clinical trial process, providing sponsors and investigative site staff with real-time reporting and access to study information. The study team can access the information at any time by logging into a secure web portal.

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Premier Research Arizona, a division of UK-based CRO Premier Research Group, finalized its deal with Pioneer Behavioral Health to acquire Pivotal Research Centers, a site management organization owned by Pioneer and specializing in phase II/IIa clinical trials.

Under the terms of the purchase agreement, Premier will pay a total of $5 million for Pivotal, with $3 million to be paid in cash to Pioneer at closing, and an additional $2 million in payments to be made if Pivotal achieves certain revenue targets over the course of the next 12 months. The original acquisition agreement, signed in January, called for Premier to make $1.75 million in additional payments, but that amount increased to $2 million before the deal was final.

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U.S. contract research organizations (CROs) are often eager to expand operations into Europe, Asia and Africa, but neighboring Canada is often omitted from CROs’ plans for global expansion. Saratoga, N.Y.-based Criterium, however, is bucking that trend with the recent opening of its Toronto office.

“Canada is one [country] that, I think, a lot of companies tend not to focus on because it sits right next to America. They run operations out of America if they can. We felt that, looking at the market, Canada has a huge amount of value that they can add to the research industry,” said Lawrence Reiter, Ph.D., director of Global Affairs for Criterium.

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PharmaNet Development Group stockholders have another week to tender their shares as part of the contract research organization (CRO)’s pending acquisition by private equity firm JLL Partners.

JLL Partners extended the expiration date for its previously announced tender offer for all of the outstanding shares of PharmaNet’s common stock. The tender offer, which had been scheduled to expire at midnight March 12, 2009, will now expire at midnight (EDT) on March 19, 2009.

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Revenues for contract research organization (CRO) MDS Pharma Services continue to fall as a result of client delays in late-stage research and decreased activity in preclinical and bioanalytical services.

First quarter net revenues for the CRO, a subsidiary of MDS, were down 12% from Q1 last year to $106 million. New business wins for Pharma Services also were down significantly over last year. New business wins for the first quarter 2009 were $104 million, down 41% from $177 million in the same period of 2008. MDS attributed this decline to “soft late-stage orders as customers continue to delay awards while reprioritizing their research and development projects.”

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Despite a pending acquisition by private equity firm JLL Partners, contract research organization (CRO) PharmaNet continues to expand its service offerings and locations.

The CRO launched a new clinical trial staffing business last week, PharmaNet Resource Solutions, which will provide on-demand staffing, strategic alliances, functional service staffing and quality control services. PharmaNet opened a new office in Sao Paulo, Brazil, last month.

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West Lafayette, Ind.-based CRO BASi appointed Anthony Chilton, Ph.D., chief operating officer, scientific services. In this role, Chilton will oversee scientific services provided to BASi’s clients from its locations in North America and Europe.

Chilton has over 30 years of experience as a scientist and executive in leading life sciences companies in England, Canada and the United States. Most recently, Chilton led early development programs at Atherogenics in Alpharetta, Ga.

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Rochester, N.Y.-based ACM Global Central Laboratory expanded its global reach with the acquisition of York, UK-based Pivotal Laboratories, a central lab serving Europe, Israel and South Africa. Neither company provided details about the terms of the acquisition agreement. ACM and Pivotal had a long-time exclusive partnership before this deal.

The Pivotal acquisition will enable ACM to further standardize and streamline its operations, according to an ACM release. Pivotal’s specific emphasis is on growing within the countries of Central and Eastern Europe.

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Bethesda, Md.-based contract research organization (CRO) United BioSource Corporation (UBC) has ended its partnership with cognitive testing provider CogState—just seven months after it began.

The partnership, originally lauded as a way for UBC to offer clients computerized cognitive testing as part of the clinical research process, ended quietly, and neither company provided much detail as to why. UBC will retain its 15% ownership stake in CogState, which the company gained as part of the original partnership agreement.

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In what CEO M. Denis Connaghan called a "challenging year," eClinical company etrials reported a decrease in year-end revenue and an operating loss for the year.

Net service revenue for the year was $15.1 million, down from $18.3 million in 2007. The company reported a net loss attributable to common stockholders’ of $15.8 million, or $1.45 per share, compared to a net loss of $6.2 million or $0.57 per share in 2007.

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Pharma Consolidation Slows CRO Market in Short Term

Pharmaceutical companies have responded to financial and market pressures by aggressively pursuing mergers and acquisitions, with the biggest being Pfizer’s planned acquisition of Wyeth. More consolidation activity is expected. The tougher economy will continue to drive change in the CRO industry during the next year. The massive layoffs in the pharmaceutical industry, along with increasing pressures for drug sponsors to control costs and improve efficiency, will result in more opportunities for CROs in the long term. Large global CROS are well-positioned to offer strategic partnerships and global services to pharmaceutical companies. In the short term, however, reduction of new projects, cancellations and delays mean that the CRO market, which had been growing at an annual rate of 15%, is expected to slow to an 8%or 9%pace this year.

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Almac Clinical Service recently opened an additional storage facility at the company’s UK headquarters to meet increasing demand for cold-chain and controlled clinical supply storage.

The new purpose-built facility, located in Craigavon, contains a 1,277 square-meter vault, holding an additional 150 pallet spaces for controlled drug storage. The facility also adds 450 extra refrigerated cold storage pallets to Almac’s existing space, with room for further expansion.

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It was another quarter of ups and downs for the clinical trial industry as contract research organizations (CROs) struggled through project delays and customer hesitation brought on by the unstable economy. In spite of the challenges, however, two CROs—ICON and Kendle—finished the year on top.

Dublin, Ireland-based ICON closed out 2008 with revenue growth of 37% to $865 million. Fourth quarter revenues increased 22% over Q4 2007 to $220 million. Net income for the year was $78.1 million or $1.30 per share, compared with $56 million or $0.94 per share, last year, and net revenue for the fourth quarter was $21 million or $0.35 per share on a diluted basis, compared with $15.9 million or $0.26 per share last year.

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Omnicare reported its fourth quarter and year-end 2008 financial results, including the results for Omnicare’s subsidiary, contract research organization Omnicare Clinical Research.

Fourth quarter 2008 revenues for the company’s CRO business remained steady at $49.1 million, compared with $49 million in the same period last year. Adjusted operating profit for the fourth quarter 2008 was $5.2 million, compared with $3.6 million in Q4 2007.

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In what could be PharmaNet Development Group’s last earnings release as a public company, the contract research organization (CRO) reported its 2008 financial information late last night without an investor conference call.

The company’s fourth quarter 2008 earnings dropped significantly year-over-year with fourth quarter net income of $1.6 million, or $0.08 per diluted share, compared with net income of $3.8 million, or $0.20 per diluted share, in the fourth quarter 2007.

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Cincinnati-based contract research organization (CRO) Kendle reported full year 2008 net service revenues of $475.1 million, an increase of 19% over the same period last year. Net service revenues for the fourth quarter were $109.2 million, up 5% over the same period 2007.

Net income for the year rose 57% to $29.4 million, or $1.96 per share on a diluted basis, compared to $18.7 million or $1.26 per diluted share for the same period 2007.

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ICON posted another quarter of growth and closed out 2008 with revenue growth of 37% to $865 million.  Fourth quarter revenues increased 22% over Q4 2007 to $220 million.

Net income for the year was $78.1 million or $1.30 per share, compared with $56 million or $0.94 per share, last year, and net revenue for the fourth quarter was $21 million or 35 cents per share on a diluted basis, compared with $15.9 million or 26 cents per share last year.

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The ethics and safety behind the global outsourcing of clinical trials is once again being debated, with the release of a new study reporting that U.S. drug developers conduct most of their late-stage drug trials outside of the United States.

The study, published in Wednesday’s New England Journal of Medicine (NEJM), reports that the number of countries conducting drug testing has doubled in the past 10 years, and, in November 2007, a total of 13,521 of 24,206 investigative sites being used for studies sponsored by U.S. big pharma were international.

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