Covance is selling its interactive voice and web response services (IVR/IWR) business to eClinical provider Phase Forward for $10 million cash, and the two companies have entered into a multi-year agreement making Phase Forward a preferred provider for the contract research organization (CRO).

Under the terms of the agreement, Phase Forward will provide electronic data capture (EDC) and IVR/IWR services to Covance clients for the next five years. The two companies expect to close the acquisition by the end of August. 

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More than six years after being convicted of fraud, two medical researchers were recently barred from working as clinical investigators by the U.S. Food and Drug Administration (FDA).

The two researchers, Mary Sawaya of Ocala, Fla., and Dr. Allyn Norman of Williamsville, N.Y., were convicted in unrelated cases.

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Wilmington, N.C.-based contract research organization (CRO) PPD is laying off a total of 270 employees in North America, including 80 employees from its North Carolina headquarters.

PPD has offices in 12 states and in Ontario, Canada, and 10,000 employees worldwide. The layoffs are a result of reduced demand for the CRO's services in North America, according to a company statement. Despite the slowdown in North America, the CRO has continued to grow its international operations with the opening of its first Japan office in April and the acquisition of Bulgarian CRO AbCRO earlier this year.

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UK-based Quotient Bioresearch recently acquired Amersham Radiolabeling Service, the radiochemical synthesis operations of GE Healthcare, and plans to invest up to 15 million pounds ($24 million) in a state-of-the-art radiochemicals facility.

Quotient closed the acquisition last month for an undisclosed sum and is rolling the Amersham capabilities into a new strategic business unit, Quotient Chemistry and Metabolism. The new facility, based in Cardiff, Wales, will open in March 2010, timed to coincide with the end of GE Healthcare's radio-labeling operations.

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MPI Research recently opened an office in Ahmedabad, India--the CRO's first location in India. Up until now, MPI has served the Indian clinical research market through its U.S. headquarters in Mattawan, Mich.

The new office will be managed by Bina Ramini, a research chemist and CRO consultant.

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Dublin, Ireland-based contract research organization ICON acquired Veeda Laboratories, a provider of biomarker laboratory services for an undisclosed sum.

The acquisition is intended to bulk up ICON's existing bioanalytical and immunoassay capabilities, which are based at a laboratory in Manchester, UK, and Prevalere Life Sciences, the U.S. lab acquired by ICON last November.

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UK-based contract research organization (CRO) Chiltern International opened a new office in Budapest, Hungary.

The new location, the company's first in Hungary, will be overseen by Attila Lorinczi, a member of the Hungarian Medical Society and the Society of Hungarian Urologists. Lorinczi has 13 years of experience in the pharmaceutical industry, most recently working as a clinical operations manager.

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EClinical provider OmniComm Systems recently acquired eResearch Technology's (ERT) electronic data capture (EDC) business in a move that OmniComm executives hope will help the Fort Lauderdale, Fla.-based company become a top-tier EDC provider.

Under the terms of the agreement with ERT, OmniComm issued 8.1 million shares of common stock and assumed certain liabilities, including deferred revenue relating to ERT's EDC business in exchange for ERT's EDC software, applications and fixed assets and $1.15 million in cash paid by ERT. OmniComm also took on 16 of ERT's 20 EDC-focused employees and plans to open a new office in New Jersey, which will house the majority of the ERT support team.

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Multinational trials have become increasingly complex and timelines have lengthened since the European Union Clinical Trial Directive 2001/20/EC went into effect. This has resulted in stakeholders' need for more staff and ultimately higher costs to run drug development programs in Europe. While stakeholders have anecdotally drawn similar conclusions, a report by The Impact on Clinical Research of European Legislation (ICREL), is now able to provide hard data to back up these claims. The report demonstrates the significant impact of the directive on all stakeholders.

ICREL collected more than 220 completed questionnaires from three of the four stakeholder groups it surveyed--commercial sponsors, non-commercial sponsors, ethics committees--as well as completed questionnaires from 23 of the 25 EU member state competent authorities and two non-EU competent authorities from countries integrated within the EU regulatory system. Data collected through these questionnaires, mainly comparing 2003 and 2007, made up 90% of the information that ICREL used to make objective analyses of the Directive's impact and prepare recommendations for areas of improvement. The remaining 10% came from open-ended comments and suggestions gathered from the questionnaires as well as a compilation of information from publications, earlier surveys and existing databases on the impact of the directive.

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China Ushers In New Era of Innovation

China's State Food and Drug Administration has implemented regulatory reforms and invested in domestic pharma to foster an innovative drug development community. Some of the reforms are also aimed at making China more attractive for inclusion in simultaneous global drug development programs for drug registration in China.

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Medidata Solutions priced its initial public offering last Thursday, following weeks of speculation over when the clinical trial software company might go public. Medidata raised $88.2 million on the NASDAQ exchange with 6.3 million shares of common stock priced at $14 a share, above its initial range of $11 to $13.

Medidata reported revenue of $105.7 million for 2008 compared with $63 million in 2007. Since its founding in 1999, Medidata has been unprofitable until its most recent quarter ended March 31, when it reported $1.7 million in net income.

Shares of Medidata Solutions rose as much as 36% to $19 in its first day of trading June 25. At press time today, shares had fallen back to $16.25 a share, still well above its pricing.

The company is trading under the symbol MDSO. 

Citi and Credit Suisse Securities acted as joint managers for the offering. Jefferies & Company and Needham & Company were co-managers.

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Indian site management organization Excel Life Sciences (ELS) and Swiss contract research organization (CRO) PFC Pharma Focus (PFC) have formed an exclusive partnership to launch a new CRO in India.

The CRO, PFC India, will offer study planning, monitoring, audit and data management services to drug sponsors needing clinical trial support in India. Set to open in New Delhi in July, the new office will be operated and staffed as a division of PFC, with ELS providing specific country expertise.

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Dedicated Phase I in Phoenix, Ariz., named a new chief medical officer to head its 80-bed phase I clinical research facility. Clark Springgate, M.D., Ph.D., brings more than 25 years' experience to the organization, having directed and participated in more than 256 clinical trials, including first-in-man and first-in-therapeutic-class studies.

"Having Dr. Springgate lead our clinical team furthers our commitment to bringing internationally known research physicians to Dedicated Phase I and Arizona's bioscience community," said Dedicated Phase I's founder and CEO Jason Bonanza.

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Fort Lauderdale, Fla.-based OmniComm Systems, a clinical trials electronic data capture (EDC) solutions company and eResearchTechnology (ERT), a global provider of cardiac safety and clinical data, announced that OmniComm has acquired the EDC business of ERT.

Revenues for ERT's EDC business were $5.9 million in the year ended December 31, 2008, and $1.4 million in the three months ended March 31, 2009.

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A new report released by ICON last week says new safety regulations have created a greater demand for resources to ensure those regulations are met.

The report is based on a survey, commissioned by ICON and market intelligence firm IMS Health, of 140 industry safety specialists within large and mid-size pharmaceutical companies. 

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A new bill introduced in the House of Representatives last week seeks to increase patient participation in clinical trials for rare diseases.

The "Improve Access to Clinical Trials Act," sponsored by Reps. Edward Markey (D-Mass.) and Cliff Sterns (R-Fla.), would enable patients with rare diseases (defined as those with fewer than 200,000 patients) to participate in clinical trials without losing their eligibility for government healthcare benefits.

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ACR Image Metrix , an imaging CRO, applies imaging techniques as a predictive and prognostic biomarker improving the efficiency for drug and medical device development programs. The team of physicians and scientists at ACR Image Metrix works with pharmaceutical, biotech and medical device companies to increase the efficiency of drug and medical device development programs by integrating the appropriate imaging modalities. In this guest commentary, assistant professor of radiology at University of Pennsylvania Medical Center Mark Rosen, M.D., Ph.D., discusses the advantages of dynamic contrast enhanced MRI (DCE-MRI).

Dynamic Contrast Enhanced MRI (DCE-MRI) in Drug Development Background

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The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited another 13 organizations last week, bringing the total number of AAHRPP-accredited organizations to 188.

AAHRPP, a non-profit organization that offers accreditation to organizations that conduct or review research with humans, hopes to accredit the majority of academic health centers by 2010. Earlier this year, Pfizer became the first pharma company to achieve accreditation.

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All companies conducting clinical trials in India must now register those trials in a clinical trial registry set up by the Indian Council of Medical Research (ICMR).

The new rule, effective June 15, requires trial sponsors to register all trials in ICMR's Clinical Trial Registry-India before they are initiated. Prior to this rule, it was only a recommendation that clinical trials be registered online with the Clinical Trials Registry (which launched in 2007) before patient enrollment began.

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Cincinnati-based contract research organization (CRO) Kendle opened three new international offices--in Kuala Lumpur, Malaysia; Bangkok, Thailand; and Manila, Philippines.

The company has been active in the Asia-Pacific region since 1998 and has existing offices in China, India, Singapore and Australia. The new offices will provide Kendle customers with additional access to patients and increased efficiencies in the clinical development process, as well as strengthen Kendle's ability to foster global strategic alliances, according to CEO Candace Kendle.

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Dublin, Ireland-based contract research organization (CRO) ICON expanded its outsourcing relationship with Eli Lilly and Company last week, as the two companies teamed up in an exclusive strategic partnership in Europe.

Under the terms of the deal, ICON will manage Lilly's clinical trial site setup and monitoring in all European countries where Lilly works, with the exception of Greece. Lilly's clinical trial activity in Greece is managed by a joint venture agreement between Lilly and Pharmaserve.

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By Linda Beneze, CEO of KIKA Clinical Solutions

One of the most exciting developments made possible by electronic data capture (EDC) is the process of adjudicating online.

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MDS Pharma Services, the CRO division of MDS, is undertaking a major renovation and expansion of its discovery operation in Taiwan as part of the company's recently announced plan to focus on early-stage clinical research.

MDS is doubling its capacity for in vivo safety and efficacy testing and improve its molecular screening and profiling capabilities at the Taiwan site. The project will be completed in 2010.

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Datatrak, a Cleveland-based  eClinical company, was delisted from the stock exchange after failing to meet NASDAQ's $2.5-million minimum stockholders' equity requirement.

The company will trade its shares over the counter under the same symbol (DATA).  The delisting came as no surprise to Datatrak, which received a letter from NASDAQ last August warning the company that it was not in compliance with the stock exchange's minimum equity requirement. Datatrak had until June 1 to comply with NASDAQ's requirements.

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On June 1, 2009, Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q1 2009, a regular analytical report on the clinical trial market in Russia. The report contains hundreds of figures as well as dozens of tables covering various aspects of the Russian clinical trial market.

The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor, RZN) approved 113 new clinical trials during Q1 2009, a 13% decrease over the corresponding period of last year.

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