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.

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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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