Monday, September 28, 2009 06:06 AM
Quintiles added another partner to its Prime Site program—an initiative to accelerate drug development and gain access to more patients.
The latest alliance with the University of Pretoria in South Africa is the third location in the contract research organization’s (CRO’s) Prime Site effort, which already includes Queen Mary’s College in London and the Washington Hospital Center in Washington, D.C.
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Friday, September 25, 2009 09:36 AM
Covance opened new clinical development offices in Sao Paolo, Brazil, and Mexico City, Mexico to further expand the contract research organization’s (CRO’s) services in Latin America and increase access to patients, the company said.
The new offices will support Covance staff in Central America and the Caribbean, as well as Covance’s Santiago, Chile; and Lima, Peru; offices, which opened earlier this year.
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Thursday, September 24, 2009 09:26 AM
Indian CRO SIRO Clinpharm partnered with UK-based regulatory consulting firm Cambridge Regulatory Services (CambReg) to offer full regulatory services to clients conducting clinical trials in Europe. Services include the preparation of clinical trial applications, marketing authorizations, specialist paediatric investigation plans and paediatric use marketing authorizations.
SIRO Clinpharm has European offices in Germany, Romania, Estonia, Greece, Czech Republic and Spain, as well as offices in India, the U.S., Israel, and Europe.
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Wednesday, September 23, 2009 06:28 AM
United BioSource Corporation (UBC) completed its second acquisition in two weeks with the purchase of Gigamoto Technology Partners, a Pennsylvania-based software company specializing in drug safety and risk management, for an undisclosed sum.
UBC has worked with Gigamoto and its founder, Jason Leedy, for several years. Under the terms of the acquisition, Leedy and Gigomoto’s 40 employees will become a part of UBC’s staff of almost 1,300 within the company’s Pennsylvania office.
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Tuesday, September 22, 2009 08:05 AM
Russian CRO Synergy Research Group (SynRG) relocated its business development operations to a new office in the United States in an effort to attract U.S. drug development sponsors.
The new office, based in North Kingstown, R.I., will be managed by SynRG’s new director of business development, Anna Ravdel. Prior to joining the company, Ravdel was director of business development at Evidence Clinical and Pharmaceutical Research and at Worldwide Clinical Trials.
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Monday, September 21, 2009 06:49 AM
Bethesda, Md.-based contract research organization (CRO) United BioSource Corporation (UBC) acquired computerized cognitive testing services company Cognitive Drug Research (CDR) for an undisclosed sum. With the addition of CDR’s cognitive testing services, UBC plans to create an integrated solution to reliably assess cognitive function—a service that UBC said is needed in the clinical trial industry.
“The measurement of cognition is, in our opinion, becoming an increasingly important part of scientific research,” said UBC president and chief financial officer Mark Clein. “In the areas of Alzheimer’s and ADHD and, frankly, even as a safety consideration for drugs in general, it’s becoming an increasingly important endpoint … CDR represented a really unique asset for us because it allowed us to expand the services that we provide in the [central nervous system] drug development area, which is a major focus of UBC.”
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Friday, September 18, 2009 07:14 AM
Dublin, Ireland-based contract research organization (CRO) ICON received industry accreditations for three of its laboratories in the UK and Singapore, and Newark, Del.-based QPS received a Good Laboratory Practice (GLP) certificate for its Taiwan operations.
ICON’s bioanalytical laboratory in Manchester, UK, received GCP and GLP accreditation from the Medicines and Healthcare products Regulatory Agency, while the CRO’s clinical pathology laboratory in Manchester received GCP accreditation. ICON now has two GLP-accredited bioanalytical laboratories, following the company’s acquisition of U.S.-based Prevalere Life Sciences in November 2008.
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Thursday, September 17, 2009 06:30 AM
BioClinica’s September buying spree continued this week with the announcement that the Newtown, Pa.-based contract research organization (CRO) had purchased technology company Tourtellotte Solutions for $2.1 million in cash, plus additional payments in the form of up to $3.2 million in cash and 350,000 shares of BioClinica common stock if certain milestones are met.
Tourtellotte, a technology company based in Wayland, Mass., with additional operations in Bhubaneswar, India, provides interactive voice response (IVR) and interactive web response (IWR) software applications and consulting services to support drug development. The company’s software is currently being used in more than 150 active clinical trials, according to BioClinica.
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Wednesday, September 16, 2009 08:01 AM
SIRO ClinPharm opened its first office in the Czech Republic to further strengthen the company’s European operations.
The new Prague office, which will initially offer clinical monitoring, biostatistics and statistical programming services, will be led by country manager Ladislav Pecen.
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Tuesday, September 15, 2009 07:12 AM
Following years of providing contract monitors to clients when needed, contract research organization (CRO) ResearchPoint is making its temporary clinical trial staffing business official through the creation of a spin-off company, ResourcingPoint.
The new business, which will provide contract clinical research associates (CRAs) to drug sponsors, will operate as a distinct company under ResearchPoint’s corporate umbrella. ResearchPoint has always provided contract CRAs to clients on as-needed basis, but customer and market demand have increased the need for this type of service.
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Monday, September 14, 2009 06:45 AM
Clinical trials offices (CTOs) have sprung up in academic health centers across the country, but the roles these offices serve vary widely from center to center, according to a new report.
“Clinical Trial Offices: What’s New in Research Administration?” was released earlier this month by the Association of Academic Health Centers (AAHC), a non-profit organization focused on academic health centers in the United States. The report showed that the trend toward consolidating or centralizing clinical trial functions in academic health centers is ongoing but still needs work, especially in terms of standardization.
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Friday, September 11, 2009 06:42 AM
Revenues continue to fall at MDS Pharma, the contract research arm of Toronto-based MDS. Third-quarter 2009 net revenues fell 28% from the same period last year, dropping to $49 million from $68 million. The year-over-year decline was a result of decreased demand for phase I and bioanalytical services, the company said.
Adjusted EBITDA for the contract research organization (CRO) was a loss of $14 million. In an effort to save $9 million annually, MDS initiated restructuring activities in the third quarter, laying off approximately 200 employees
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Thursday, September 10, 2009 06:27 AM
The Drug Information Association (DIA) appointed Paul Pomerantz as its new worldwide executive director, replacing William Brassington who has served as acting executive director since July 2008.
Pomerantz is currently executive vice president of the American Society of Plastic Surgeons, an association of more than 7,000 reconstructive and cosmetic plastic surgeons, and will transition to his new role at DIA as of December 1.
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Tuesday, September 8, 2009 04:37 PM
Averion, a contract research organization (CRO) specializing in oncology, cardiovascular diseases and medical devices, has filed a statement with the Securities and Exchange Commission (SEC) as it plans to go from a publicly traded company to one that is private.
The move will reduce the costs and administrative burdens of running a public company, Averion said, as well as allow shareholders with small holdings in the company to immediately realize the value of their investment.
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Tuesday, September 8, 2009 06:21 AM
Newtown, Pa.-based contract research organization (CRO) BioClinica is continuing its efforts toward becoming a clinical trial technology “super brand” with its recent acquisition of the CardioNow unit of Agfa Healthcare.
The acquisition consists mainly of Agfa’s CardioNow technology, but two key employees—one from sales and one from operations—have joined BioClinica’s staff. BioClinica did not release financial terms of the deal.
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Friday, September 4, 2009 11:14 AM
Covance is expanding its capacity to support specialized sleep studies through a collaboration with Sleep Medicine Associates.
The collaboration gives Covance access to Sleep Medicine Associates’ clinical research facility and specialized support for studies targeting insomnia, restless leg syndrome, narcolepsy, fibromyalgia, and other conditions related to the central nervous system.
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Thursday, September 3, 2009 05:24 AM
So much for MDS’ plans to focus its Pharma Services unit on early-stage drug development.
The Toronto-based company, which sold its late-stage contract research business earlier this summer to focus on discovery through phase IIa proof-of-concept services, is now looking to sell off the rest of its contract research organization (CRO), MDS Pharma Services, including its early-stage services and its Global Central Labs division.
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Wednesday, September 2, 2009 07:19 AM
According to an Orange Paper released by Russia-based CRO, Synergy Research Group, Russia’s health agency, the Federal Service on Surveillance in Healthcare and Social Development (RosZdraNadzor, RZN) approved only 129 new clinical trials, including local and bioequivalence studies, during Q2 2009, representing a 17% decrease from Q2 last year. The percentage of approved multinational clinical trials increased slightly, however, to 65% of the total during this time period.
For phase II to IV clinical trials launched in Q2, 12,338 patients were enrolled—nearly the same as the 12,000 enrolled in the same quarter last year.
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Tuesday, September 1, 2009 07:28 AM
CenterWatch, Thought Leaders Mark 15 Years of Industry Growth
With CenterWatch reaching the milestone of its 15th anniversary this month, we asked industry thought leaders to reflect on this remarkable period of change and growth for our special issue. The answers are insightful and chronicle just how far the industry has come.
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Monday, August 31, 2009 10:23 AM
Manchester, England-based Synexus plans to double its operations in Poland through the acquisition of three clinical trial sites.
The sites, owned by CLCC (which, in Polish, stands for the Center for Civilized Studies in Research), are located in Warsaw, Gdynia and Katowice and will complement Synexus’ existing Polish site in Wroclaw. Although a much smaller business than Synexus, which has 250 employees and 17 research centers across the UK, Poland, Hungary, Bulgaria, India and South Africa, CLCC is a site management organization (SMO) like Synexus with dedicated research centers.
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Friday, August 28, 2009 07:32 AM
LabConnect, a provider of central laboratory services to the clinical trial industry, appointed former Quintiles executive Frank Morrow, Ph.D., as its chief operating officer.
Morrow was founding executive, president and chief scientific officer at Quintiles Laboratories Worldwide before joining LabConnect. According to LabConnect, he was responsible for growing Quintiles’ lab from inception to $120 million in revenue, 1,000 employees and five worldwide central lab facilities.
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Thursday, August 27, 2009 09:16 AM
The U.S. Food and Drug Administration published two new rules to help seriously ill people gain access to investigational drugs when they are not eligible for clinical trials and have exhausted other treatment options.
The rules, which go into effect in mid-October, clarify the procedures, standards and costs of providing investigational drugs as part of a clinical trial or when used outside the scope of a trial.
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Wednesday, August 26, 2009 05:19 AM
Colorado Prevention Center (CPC), a non-profit academic research center in Denver, has launched an online course for business operations people working in the clinical trial industry to help familiarize them with the workings of the industry.
“Clinical Trials Training for Business Operations Professionals” was designed to give non-clinical staff a basic foundation of industry knowledge. The curriculum is based on a course CPC created for clinical research coordinators to speed their learning process and reduce turnover. CPC pared down the information to be most applicable to people not directly involved in the clinical trial process.
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Tuesday, August 25, 2009 07:08 AM
Encorium’s losses continued to grow in the second quarter, increasing $604,000 to $1.3 million or $(0.06) per diluted share, compared with a net loss of $665,000, or $(0.03) per diluted share for the same period last year.
Net revenue for the quarter also plunged to $4.5 million, a 23.37% drop compared with last year’s quarter. Year-to-date revenues were $9.02 million, down from $11.32 million in 2008.
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Monday, August 24, 2009 06:50 AM
Phase Forward’s recent multi-million-dollar agreement with Swiss contract research organization (CRO) SGS Life Science Services not only provides the stability of a long-term contract to Phase Forward but also helps the eClinical provider advance its core strategy.
“We have a direct strategy, and it’s all around an integrated clinical research suite. This is what we feel is the direction of the industry, and it’s where we as an organization are headed to support. We also have a distinct and separate CRO strategy, and this kind of bridges that gap as well,” said Mike Davies, Phase Forward’s vice president of global CRO partnerships.
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