Contract research organization (CRO) Parexel recently completed one of the first Chinese bridging studies to be conducted outside of China at the CRO’s Los Angeles facility. The study, conducted this spring, is one of a number of ethnobridging studies being pioneered by California Clinical Trials (CCT), which Parexel acquired two years ago.

When Waltham, Mass.-based Parexel acquired CCT, the CRO hoped to leverage CCT’s expertise in bridging studies. The company’s dedicated research unit in California provides access to large first generation Asian populations, and, with CCT’s help, Parexel has conducted more than 45 Japanese bridging studies and, now, one Chinese study.

More... »

In his regulatory keynote address at the China Trials 2008 conference in Shanghai, Dr. Yi Feng, director, Office of Review Management, Center for Drug Evaluation (CDE), State Food and Drug Administration (SFDA) gave a broad overview of the evolution of global clinical trials in China and pinpointed future trends and goals in the country.

Feng said the key to the future of the clinical research market in China is clear: “The regulatory agency and industry need to work together to create better synergy.” Big Pharma, whose key players in the Asia-Pacific region attended, agreed.

More... »

In his presentation at China Trials 2008 in Shanghai, “Conducting Global Post-Marketing Surveillance Studies in China—Opportunity and Practical Issues,” Mark Engel, president and chairman of Excel PharmaStudies, a large China-based contract research organization, identified two megatrends that will drive post-marketing surveillance studies to China: the rapid aging of its population and its increasingly insured rural population.

With Congress recently giving approval for the U.S. Food and Drug Administration to enforce post-marketing studies by fining sponsor companies for not doing them, the clinical research environment has become subject to more stringent requirements than expected. Engel described the fallout: Clinical trials are now larger than expected, their duration is longer and their requirements are broader. As an example, he said that any diabetes submission now requires a long-term cardiovascular surveillance study.

More... »

CenterWatch, a global source for clinical trials information, announced today that it is the three-time recipient of the Gold eHealthcare Leadership Award for Best Health/Healthcare Content in the Other Healthcare Sites category presented by Strategic Health Care Communications. The award, given at the 12th Annual Healthcare Internet Conference in Orlando, Fla., marks the fourth consecutive year CenterWatch has been honored winning platinum in 2005.

With more than 1,100 entrants competing in 17 classifications this year, the eHealthcare Leadership Awards program recognizes the best web sites in the healthcare industry and the Internet’s important role in helping organizations achieve their business goals.

More... »

The Drug Information Association (DIA) has expanded its worldwide operations by opening an office in Beijing, China. Headquartered in Horsham, Pa., DIA has regional offices in Switzerland, Japan, and now China.

The Provisional Advisory Council of China (pACC), established by the DIA in May 2008, will provide support and strategic oversight of DIA’s China office.

More... »

Averion, a contract research organization (CRO) specializing in oncology, reported its third quarter revenues more than doubled following its acquisition of Swiss CRO Hesperion.

Net service revenue for the three months ended September 30 was $15.9 million, compared with $7.8 million for the same period last year. The Southborough, Mass.-based company’s direct expenses for the third quarter of 2008 increased $5.7 million over third quarter 2007 to $9.9 million. The Hesperion acquisition, completed in October 2007, contributed $5.4 million to those third quarter expenses.

More... »

Faced with an increasingly competitive market and possible financial losses in the future, Mayo Clinic is shutting down its 17-year-old Mayo Clinical Trial Services (MCTS) Unit.

The Rochester, Minn.-based unit provides lab analysis and data management services to pharmaceutical companies that want to bring drugs to market. The unit opened at a time when there was a market for these types of services that was not being met, according to Mayo spokesperson Adam Brase.

More... »

Just a day after releasing disappointing third quarter results, Morrisville, N.C.-based eClinical company etrials named a new president and CEO, M. Denis Connaghan, replacing interim president and CEO Chuck Piccirillo. Piccirillo, who will resume his position as vice president of technology, has served as interim CEO since the resignation of Eugene “Chip” Jennings in July. Connaghan was formerly managing director within Marsh USA’s Global Operations.

Other personnel news from the clinical trials industry:

More... »

WuXi Pharmatech released final third quarter earnings that reflected 98% revenue growth year-over-year but fell short of the company’s projected Q3 earnings.

Net revenues for the quarter were $67.5 million, down from the $74 million originally forecast. The Chinese contract research organization confirmed its most recent revised full-year revenue guidance of $260 million to $265 million. WuXi share prices dropped 5% to $7.42 in morning trading Thursday.

More... »

Morrisville, N.C.-based eClinical company etrials reported another quarter of loss, with net losses for the third quarter at $6.1 million, compared with $1.3 million for the same period last year and $2.2 million in net losses for the second quarter of 2008.

Net service revenues were $3.7 million for the third quarter of 2008, down from the same period last year ($4.1 million) and the second quarter of 2008 ($4 million).

More... »

Two years after expanding its clinical trial management services to South Africa, site management organization (SMO) Synexus Clinical Research is doubling its late stage clinical trial capacity within the country.

The Manchester, England-based SMO plans to expand its existing facility as well as open two others by early next year. The first facility in Pretoria, one of South Africa’s three capital cities, is being refurbished and expanded into an abutting facility. New sites will open in Soshanguwe and Mamelodi, two townships about a 30-minute drive from Pretoria.

More... »

GlaxoSmithKline (GSK) has made a big investment in China, betting that the future of drug development will be led by that country.

In his keynote address, "From ‘Made in China’ to ‘Discovered in China,’" at the China Trials 2008 Global Clinical Development Summit in Shanghai, Perry Nisen, M.D., Ph.D., senior vice president, Cancer Research at GlaxoSmithKline (GSK), emphasized the importance of China with regard to GSK’s global strategy. Nisen said that if GSK’s China initiative is not successful, “it is going to hurt the company” because it has invested so much there. “Our decision was that we really wanted to do it from the beginning to the end.”

More... »

Bio-Imaging Technologies saw a big jump in its third quarter revenues thanks to the March 2008 acquisition of eClinical company Phoenix Data Systems (PDS).

Service revenues for the Newtown, Pa., CRO grew 57.9% to $15.1 million for the third quarter fiscal 2008, compared with $9.6 million for the same period last year. PDS accounted for $4 million of revenue.

More... »

Wilmington, Mass.-based Charles River Laboratories saw slower than expected sales growth in its Preclinical Services Segment (PCS) during the third quarter, prompting the preclinical contract research organization (CRO) to reduce its 2008 profit and revenue-growth forecasts. Strong sales in Charles River’s Research Models and Services (RMS) segment helped offset the performance of PCS, but the company reduced the high-end of its full-year sales growth percentage forecast by 4%, from 14% to 10%.

“Our clients our continuing to invest in drug discovery development, but they are facing a range of unprecedented challenges,” Charles River chairman, president and CEO James Foster said in a company statement. “To address these challenges, our clients are restructuring their businesses, reprioritizing their drug development pipelines and shifting focus to drugs in late-stage development. These actions are leading to significant and accelerating study slippage and delays, pushing work from 2008 into 2009.”

More... »

Cincinnati-based contract research organization (CRO) Kendle reported third quarter net service revenues of $124.8 million, an increase of 25% compared with the same period last year. Approximately 6% of the CRO’s revenue growth resulted from the June acquisition of DecisionLine, a Toronto-based phase I company focused on the central nervous system (CNS).

New business awards for the quarter totaled a record $212 million, an increase of 21% compared with the same period 2007. Kendle reduced the low end of its full-year revenue guidance just slightly to $485 million from $490 million. The high-end guidance remains at $500 million.

More... »

No Standard Policy for Conflicts of Interest

Many research organizations have taken actions to strengthen their policies for managing financial conflicts in recent years. Despite individual organizations’ efforts, there are no universally accepted standards for managing conflicts of interest in clinical research. Nor is there a model policy to aid institutions in the development of their own policies.

More... »

ASKA Research, a contract research organization (CRO) based in Vancouver, Canada, is expanding its clinical trial services into Japan through a strategic partnership with Japanese CRO ASKLEP.

The partnership with ASKLEP will allow ASKA to create a presence in Japan while helping ASKLEP advance in North America. ASKLEP, which is expanding into other parts of Asia, will do all the on-the-ground work in Japan and Asia while ASKA manages North America.

More... »

Philadelphia, Pa.-based eResearch Technology saw its revenue growth wane slightly in the third quarter but still maintained a 41.5% increase compared with the same period last year. The eClinical company reported net revenues for the quarter of $33.9 million up from $24 million in the third quarter of last year. Diluted net income per share was $0.13 compared with $0.07 in the third quarter of 2007, and gross margin was $19.1 million.

Revenues were down slightly from the second quarter of 2008, which was $35.5 million, due to slower activity in the summer months and a working down of backlog, according to president and CEO Dr. Michael McKelvey. eResearch narrowed its full year revenue guidance from $141.4 million to the range of $134 million to $137 million.

More... »

PharmaNet Development is the latest contract research organization (CRO) to release disappointing quarterly earnings as a result of contract cancellations, slow sales and negative foreign exchange rates. Princeton, N.J.-based PharmaNet reported a decrease in direct revenue to $89.2 million, down $10 million, or 10.6%, from the same period last year. Almost $1.5 million of that drop was a result of foreign currency exchange translation.

Although PharmaNet’s early stage segment saw a 13.2% increase in direct revenues, revenues from the late stage segment fell 25% to $46.6 million due to contract cancellations and postponements. The company’s backlog was also down from $579.2 million in June to $521.6 million as of September 30.

More... »

Waltham, Mass.-based eClinical technology company Phase Forward reported a 23% jump in third quarter revenues to $43 million from $34.9 million in the third quarter of 2007.

Non-GAAP net income for the period slid to $5.4 million compared with $6.9 million in the third quarter of 2007. The decline was due primarily to an increase in the company’s tax rate from 10.3% in the third quarter of 2007 to 36.2%, according to Phase Forward president and CEO Bob Weiler.

More... »

Waltham, Mass.-based contract research organization Parexel reduced its 2009 fiscal year guidance, and share prices plunged more than 40% to $8.05 in late morning trading.

Citing slower than expected sales in September and a negative impact from foreign exchange rates, the company lowered its full-year consolidated revenue guidance to $1.1 to $1.3 billion, down from $1.22 to $1.25.

More... »

China has seen significant growth in the area of drug research and development in the past few years, and this growth will continue into the fourth quarter of 2008 with the opening of two new preclinical facilities in Shanghai.

Earlier this month, preclinical contract research organization (CRO) MPI Research opened a 50,000-square-foot building in Shanghai’s Chuansha Economic Park. The new facility, a result of a recently formed joint venture between MPI Research and Shanghai Medicilion, will provide preclinical drug discovery and development services in Asia.

More... »

By Douglas Bain, vice president, Global Operational Excellence, Medidata Solutions Worldwide

During the last 10 years, a great number of experts across the eClinical industry have invested a considerable amount of work into an extremely complex balancing act: ensuring that clinical study development tools are flexible and simple-to-use, while also delivering on the promise of interoperability and the ability to output submission-ready data sets. Of particular note are the efforts of the Clinical Data Interchange Standard Consortium (CDISC), resulting in the Study Data Tabulation Model (SDTM), Operational Data Model (ODM) and recently published Clinical Data Acquisition Standards Harmonization (CDASH) standards.

More... »

Although Princeton, N.J., CRO Covance experienced a number of third quarter cancellations and project delays, the company posted 11.1% revenue growth for the third quarter. Profit rose 15% to $51.1 million, or $0.80 per diluted share.

Backlog as of September 30 grew 62.1% to $4.25 billion compared with the same period last year, thanks in large part to the recent 10-year, $1.6 billion agreement with Eli Lilly, which created $1.27 billion in backlog for Covance.

More... »

PPD, a contract research organization (CRO), reported third quarter revenue increased 11.6% to $398.5 compared with $357.2 million for the third quarter of 2007. Diluted earnings per share jumped 34% to $0.43 per share.

The company lowered its full-year revenue projection to between $1.47 billion and $1.49 billion from $1.54 billion to $1.59 billion as a result of a FDA delay in approving diabetes drug alogliptin.

More... »