Dublin, Ireland-based contract research organization ICON reported strong first quarter net revenues with an increase of 9.2% to $201.3 million compared with the same quarter last year, a 25% hike in profit and hopes to add to that performance by acquiring a 100-bed phase I unit in Omaha, Neb.

"The last quarter represented a solid start to 2009," said Chairman Dr. John Climax. "Revenue was 9% ahead of prior year and earnings per share were up 25%."

More... »

Now that Newtown, Pa.-based contract research organization Bio-Imaging Technologies has completed its integration of Phoenix Data Systems, which it acquired in March 2008, the company has changed its name to BioClinica. The new name also marks the start of an active acquisition phase for the 450-employee company, which plans to acquire more companies in the clinical research services space.

“We started this whole re-branding about four months ago. This is a situation that is not going to be a yearly event. We’re going to do this once,” said Mark Weinstein, president and CEO, BioClinica. The name change was announced at IIR's 18th Annual Partnerships with CROs conference in Orlando.

More... »

Parexel International, a global contract research organization (CRO), reported an 8% increase in service revenue for its third quarter, flat quarterly profits, but raised its profit outlook for 2009. The CRO’s shares jumped 17.7% in after hours trading to $9.51 a share after closing Monday at $8.08.

The Waltham, Mass., company recorded service revenue of $264.5 million for the third quarter ended March 31, up from $245.3 million a year ago. Excluding the negative impact of foreign exchange and the net positive impact of acquisitions and divestitures of $17 million from the third quarter of fiscal year 2009, and $900,000 in divestitures from the third quarter of fiscal year 2008, revenue grew 15.8% year-over-year.

More... »

Coast IRB, the institutional review board (IRB) that was the target of an undercover investigation by the Government Accountability Office (GAO), is closing its doors, according to reports published last week.

The FDA had issued a warning letter to Coast earlier this month, outlining five “serious violations” to FDA laws and regulations and questioning the IRB’s ability to protect human subjects participating in clinical trials. In response to the letter, Coast voluntarily suspended the approval of new studies as well as the recruitment of new patients for ongoing studies and planned to issue a corrective action plan to the FDA by the end of April.

More... »

Three companies—Phase Forward, Chiltern International and ChemDiv—are the latest clinical trial companies to complete global acquisitions.

eClinical company Phase Forward acquired Waban Software, a Cambridge, Mass.-based clinical data analysis and reporting company with operations in Mumbai, India; UK-based contract research organization (CRO) Chiltern acquired Vigiun, a CRO in São Paulo, Brazil; and San Diego, Calif.-based ChemDiv (a contract research discovery and development organization) purchased Russian CRO Prudentas.

More... »

Ecron Acunova, a CRO based out of Germany, India and the United States, appointed Antal Hajos managing director and CEO Europe, replacing ECRON founder and CEO Klaus Wiedey, who will serve as an advisor to the company. In his new role, Hajos will oversee all business, strategic and operational aspects of the European operations. Prior to joining Ecron Acunova last year, Hajos was director of global clinical operations with Altana Pharma and later CEO of Altana/Nycomed’s research and development center and Indian affiliate in Mumbai, India.

Other personnel news from the clinical trial industry:

More... »

Phase Forward, an eClinical company, acquired Waban Software, a Cambridge, Mass.-based clinical data analysis and reporting company with operations in Mumbai, India, for $14 million in cash.

Phase Forward’s Waltham, Mass., headquarters will become the local headquarters for Waban, which has 81 employees worldwide. Current Waban president Himanshu Oberoi, Ph.D., will become vice president, Waban Software Group, Phase Forward.

More... »

Wilmington, N.C-based contract research organization (CRO) PPD reported first quarter 2009 earnings late yesterday along with the opening of its first office in Japan and the completion of the acquisition of AbCRO, a Bulgarian CRO.

The new office in Tokyo will expand the CRO’s phase II to IV clinical development services in East Asia.

More... »

UK-based contract research organization (CRO) Chiltern International continued its global expansion efforts with the acquisition of Vigiun, a CRO in São Paulo, Brazil, for an undisclosed amount.

Chiltern began operating in Latin America a year ago in Argentina, but the Vigiun deal will strengthen the company’s presence in the region, said John Vann, Chiltern’s executive vice president, Americas. Chiltern now has offices in Brazil, Argentina, India, the UK and the United States.

More... »

Radiant Research’s recent partnership with India-based Spectrum Clinical Research will, for the first time, expand Radiant’s contract research organization (CRO) division beyond North America.

The partnership with Spectrum, a CRO/site management organization in Mumbai, will enable Radiant to manage and monitor clinical trials conducted in India, as well as offer seven sites in India through the Spectrum network. Radiant’s agreement with Spectrum is still evolving, according to Radiant’s vice president of late phase clinical research Julie McHugh, who would not disclose the terms of the deal.

More... »

CenterWatch, a global source for clinical trials information, announced today the planned release of its fifth edition of the annual sourcebook, State of the Clinical Trials Industry, due out in late May.

With more than 645 charts and graphs, including 400 that are new or updated, State of the Clinical Trials Industry offers a detailed examination of the global clinical trials industry and provides proprietary charts and graphs from CenterWatch’s clinical research benchmarking surveys.

More... »

India-based contract research organization (CRO) GVK Biosciences formed a strategic alliance with Excel PharmaStudies, a CRO in China, to offer clinical trial services across India and China.

The two companies will help sponsors conduct and manage phase II to IV clinical trials, statistical analysis and medical writing. Under the terms of the agreement, any India trial for Excel will be conducted by GVK Biosciences and any China trial for GVK Biosciences will be conducted by Excel.

More... »

Facing FDA concerns about its ability to protect human subjects participating in clinical trials, Coast Institutional Review Board has voluntarily suspended the approval of new studies as well as the recruitment of new patients for ongoing studies.

These actions may involve up to 300 active trials conducted by 3,000 clinical investigators, the FDA announced yesterday. Studies that Coast IRB already has approved will be permitted to continue but no new patients will be enrolled.

More... »

Covance opened new clinical development offices in Santiago, Chile, and Lima, Peru, and expanded its office in Buenos Aires, Argentina, increasing the contract research organization (CRO)’s presence in Latin America.

The expanded facilities will help the company expedite clinical studies in Latin America, as well as develop strategic relationships with investigators, sites and regulatory authorities in the region, according to Covance, which has operated in Latin America since 1997 when it opened its Argentina office.

More... »

ReSearch Pharmaceutical Services’ (RPS) plan to acquire a small contract research organization (CRO) in China will expand the company’s capabilities in Asia, but the deal is also part of a larger plan to expand RPS throughout the world by multiple acquisitions.

RPS plans to acquire Paramax International for $1 million in cash and 530,973 shares of RPS common stock. RPS CEO Dan Perlman said the Paramax acquisition, expected to close in May, is the latest step in RPS’ global growth plan to have offices in Western Europe and Asia. RPS acquired three European CROs—Imerem, Infociencia and Therapharm—in December.

More... »

Pfizer’s Enhanced Clinical Trial Design Saves $100 Million Annually

Late-phase failure is an industry wide problem. Pfizer’s initiative, Enhanced Clinical Trial Design (ECTD), uses established statistical modeling approaches in an innovative manner to better size clinical trials and to stop inefficient drugs earlier.

More... »

Cancer treatment and research network US Oncology has established a contract research organization (CRO), formalizing many of the CRO services that the organization already provided.

US Oncology Clinical Development will provide oncology-specific CRO support for phase I to phase IV clinical trials, including physician advisory boards, safety data collection and regulatory submission, medical writing and protocol development, biostatistics, site selection and payments, and central institution review board (IRB).

More... »

Pfizer is the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs. Pfizer (and its phase I clinical research units) was among 16 organizations to receive accreditation this quarter, bringing the total number of AAHRPP-accredited organizations to 175.

“Pfizer is proud to be the first pharmaceutical or biotech company to obtain AAHRPP accreditation and take our place alongside some of the best universities and hospitals that are also AAHRPP-accredited,” said Pfizer chairman and CEO Jeffrey Kindler in a company statement. “Accreditation is part of Pfizer’s ongoing efforts to demonstrate our commitment to integrity and increased transparency in research and operations.”

More... »

PPD acquired Magen BioSciences, a dermatology-focused biotechnology company—just as the contract research organization (CRO) announced plans to divest its preclinical research subsidiary Piedmont Research Center.

PPD purchased Waltham, Mass.-based Magen for $14.5 million in cash. According to a PPD spokesperson, most of Magen’s employees will join PPD as part of the acquisition, including Magen’s co-founder Sandra Luikenhuis, Ph.D., who will serve as executive director, dermatology. Magen’s CEO Brian Gallagher will not be staying on with the company.

More... »

ReSearch Pharmaceutical Services (RPS) has entered into an agreement to acquire Chinese contract research organization (CRO) Paramax International for $1 million in cash and 530,973 shares of RPS common stock.

The deal, expected to close in late May, will expand RPS’ capabilities in the Asian market by serving as the company’s Asian base of operations. Paramax is headquartered in Beijing, China, with an operations office in Shanghai.

More... »

Full-year 2008 revenues for oncology CRO Averion increased 90% over 2007, thanks in large part to an increase in European activity and the October 2007 acquisition of Hesperion, a clinical research organization based in Switzerland. Net service revenues in 2008 were $66.4 million, compared with $34.9 million in 2007.

"We were very pleased to have recorded $35.9 million of net revenues in Europe during 2008, which represents an all-time record for our European operations. During the twelve months ended December 31, 2008, we began to see the positive impact of our expanded global footprint in the number of new business opportunities we have been asked to bid on,” said CEO Markus Weissbach, M.D., Ph.D., in a company statement.

More... »

In 2007, drug development in Japan, the world’s second largest pharmaceutical market, exploded six-fold over 2006 and should continue to grow, according to a new CenterWatch report released today.

Japan: Opening the Door to Global Clinical Trials, the fourth in a series of CenterWatch reports on global clinical research markets, takes a look at the reasons for Japan’s dramatic growth, the differences in the country’s approach to clinical research, and government initiatives to attract Big Pharma to conduct simultaneous global clinical trials in Japan.

More... »

Japan’s regulatory authority, Pharmaceuticals and Medical Devices Agency (PMDA), is launching several new initiatives in fiscal year 2009, which begins today. PMDA representatives were out in force at the DIA EuroMeeting in Berlin last week to explain the new programs, which will be implemented between fiscal year 2009 and fiscal year 2013.

PMDA’s goals for the next five years include continuing to try to eliminate drug lag and further increase Japan’s participation in global clinical trials. The agency’s previous initiatives have already met with great success in terms of investigator participation in global clinical trials, which increased six-fold between 2006 and 2007.

More... »

Contract research organization (CRO) PharmaNet is officially a private company after private equity firm JLL Partners completed its acquisition of the CRO yesterday.

The merger followed the successful completion of JLL’s tender offer to purchase all outstanding PharmaNet shares at a price of $5 per share in cash. The transaction valued the company’s stock at approximately $100 million.

More... »

Dublin, Ireland-based contract research organization (CRO) ICON is partnering with MedAvante, a provider of psychological rating services, to improve the efficiency and effectiveness of central nervous system (CNS) clinical trials.

CNS trials, which generally test drugs designed to treat mental disorders, are often difficult to monitor because of bias and variability in the assessment process. Because of this variability, CNS trials often require large patient populations and can result in uninformative or failed studies. MedAvante, which was founded in 2002, offers a centralized and standardized process for assessing CNS trials.

More... »