Raleigh, N.C.-based CRO  INC Research added electronic patient reported outcomes (ePRO) services to its offerings through a partnership with ePRO provider invivodata. Prior to the formation of the strategic partnership, the two companies collaborated on multiple international clinical trials.

“We chose to partner with invivodata based on the integration of scientific and regulatory principles into their ePRO solution—elements critical in ensuring high patient compliance and reliable data,” said Alistair Macdonald, INC Research’s executive vice president, strategic development, in a statement. “By leveraging our relationship with invivodata, we can continue to guide our customers through any regulatory changes that may affect their research decisions, especially in light of the recent publication of the FDA's final PRO Guidance.”

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Quintiles expanded its London-based phase I facility by 35 beds, bringing the total number of phase I beds in London to 105 and globally to 385. The CRO said this number will increase even further later this year as a result of the planned opening of a phase I unit in Hyderabad, India. That facility will initially have 50 beds with capacity for 100.

The larger London facility is adjacent to one of only five Biomedical Research Centres (BRCs) in the UK. BRC designation and associated funding is awarded by the government to encourage innovation and translational research in biomedicine. Quintiles said it will work closely with the BRC as appropriate.

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Kendle plans to open a new facility in India by the middle of April. The new unit will be based in a Special Economic Zone (SEZ) in the upcoming Ahmedabad-Gandhinagar Knowledge Corridor. The Indian government has established SEZs throughout the country to increase foreign investment and business.

Kendle already has offices in Ahmedabad and New Delhi. The contract research organization (CRO) will initially employ 50 people at the SEZ operations center with room to grow to up to 300. The company will offer the following services at the new facility: clinical data management, medical writing, pharmacovigilance/safety, biostatistics/programming and other knowledge processing-related services.  

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MDS completed its sale of the discovery and preclinical business of MDS Pharma Services, the company’s contract research organization (CRO).  Under the terms of the deal, CRO Ricerca Biosciences of Concord, Ohio, acquired facilities in Bothell, Wash.; Lyon, France; and Taipei, Taiwan. Those facilities have 600 employees.

Ricerca is an early-stage CRO with capabilities in discovery and medicinal chemistry, API process chemistry, cGMP manufacturing and scale-up, and IND-enabling toxicology. MDS Pharma will add molecular profiling, pharmacology/DMPK and drug safety assessment to its list of services.

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The University of Oklahoma’s OU Cancer Institute (OUCI) is partnering with strategic research organization Sarah Cannon Research Institute (SCRI) to expand the school’s early-phase oncology clinical trials program.

Founded nearly 10 years ago, OUCI wanted to expand its work in early-stage trials, said OUCI’s director Robert Mannel, M.D. OUCI is currently conducting more than 100 research projects supported by $20 million in funding from sponsors including the National Institutes of Health, the National Cancer Institute and the American Cancer Society.

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According to Russia-based contract research organization (CRO) Synergy Research Group’s Annual Orange Report, Russia’s regulatory agency Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor, RZN) approved 577 new clinical trials during 2009, 6% fewer than in 2008. Sixty percent, or 348 of the new studies, were multinational multi-center trials, down 4% from 2008.

Clinical trials in Russia in 2009 were sponsored by pharmaceutical companies from 28 countries. Most of them, 191, were initiated by Russian sponsors. U.S. sponsors initiated 128 trials followed by 51 trials by German sponsors, 42 by Swiss sponsors, 35 by UK sponsors, and 34 by Japanese sponsors.

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Chinese CRO WuXi PharmaTech expanded its strategic collaboration with Johnson & Johnson Pharmaceutical Research and Development(a division of Janssen Pharmaceutica) to provide preclinical services to Janssen and to eventually offer Good Laboratory Practice (GLP) toxicology services at WuXi’s facility in Suzhou, China.

Under the terms of the agreement, Janssen will provide training—reimbursed by WuXi—to help the CRO establish the GLP quality system and technical capabilities to begin supporting GLP toxicology studies later this year.

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PPD is investing up to $19 million to develop a new 18,000-square-foot analytical testing laboratory and clinical supplies business in Athlone, Ireland.

The contract research organization (CRO) will offer the following product and analytical development services there: method development; validation; stability; release and quality control testing; and global clinical supplies services, including secondary packing, labeling and storage. The facility will also provide regulatory services, product licensing and marketed product support, with emphasis on inhalation and biopharmaceutical products. The analytical testing laboratory will conduct testing for all phases of drug development.

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Philadelphia-based eResearch Technology (ERT) reported a 60% drop in net income in 2009 compared with 2008. Net income in 2009 was $10.7 million, or $0.22 per diluted share, compared with $25 million, or $0.48 per diluted share, for full-year 2008.

Net revenues were $93.8 million for the year, compared with $133.1 million in 2008.

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Year-end revenues for Dublin-based CRO ICON increased 3% in 2009 to $888 million. Fourth quarter revenues also increased 3% to $227.4 million compared with $220.1 million for the same period last year.

Net income grew 17% to $91.6 million compared with $78.1 million last year.

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Demand for Contract Staffing Grows as Pipeline Ramps Up

In the past decade, the contract research staffing space has undergone a major transformation. Now, large staffing companies, such as Kelly Services and Aerotek, work in the space along with a number of global CROs and smaller niche contract staffing companies.

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Healogica is the latest clinical trial listing service to shut its doors, but the company’s trial matchmaking technology may live on if company founders get their wish.

Healogica plans to close its New York City operations in the coming months, but co-founder Jean-Luc Neptune, M.D., said he is hopeful that a suitable buyer will resurrect the company’s clinical trial listing platform.

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Parexel opened a new early phase unit in Port Elizabeth, South Africa, giving the contract research organization (CRO) its third early-phase facility in that country.

The new unit adds 40 beds to Parexel’s global early phase capacity of 580 beds. The CRO’s other South African early phase units are in Bloemfontein and George, and global facilities are located in the U.S., UK and Germany.

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UK contract research organization (CRO) Chiltern International and preclinical CRO Charles River Laboratories are partnering to conduct and support early-phase radiolabelled studies.

The two companies will collaborate on studies using radiolabelled investigational products out of the CROs’ Europe-based facilities.

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Kendle plans to reduce staffing levels in the coming months in response to decreased sales and customer demand.

The Cincinnati contract research organization (CRO) reported a drop in revenues for both the fourth quarter 2009 and year-end. Fourth quarter revenues were $96.6 million in 2009, compared with $109.2 million for the same period 2008.  Net income for the quarter was $2.3 million or $0.16 per diluted share.

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PPD expanded its operations in the Asia-Pacific region with the opening of a new office in Manila, Philippines—the company’s first office in the Philippines—and an additional office in India.

PPD said the new facilities will help the contract research organization (CRO) meet increasing client demand for phase II to phase IV services in the Asia-Pac region.

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Raleigh, N.C.-based CRO INC Research launched an alliance partnerships program to create and manage strategic alliances with pharmaceutical and biotech customers. The company said it hopes to create relationships with customers based on joint strategic objectives rather than service agreements.

The services provided by INC through these relationships can include complete management of a compound or therapeutic area, management of a specific function or set of critical processes, sharing in the risk and reward of a compound's performance, or acting as the sole source development partner for a customer. Tim Dietlin was appointed vice president, alliance development, to oversee the effort.

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Quintiles added anatomic pathology to the service offerings it provides at its central laboratory in Beijing, China. The new services complement assay development, digital pathology and core lab offerings, which the Beijing facility already offers to help customers comply with China’s restrictions on tissue import and export.

“Within China, we are providing the tools and infrastructure to investigate cancer and match patients with optimum treatments for their genetic makeup,” said Christopher Ung, Quintiles’ vice president of strategic business and operations, oncology. “These capabilities enable personalized medicine and enhance oncology research to bring medicines to market faster.”

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ResearchPoint recently added India-based GVK Biosciences to its ResearchPoint Global network, increasing the number of affiliate contract research organizations (CROs) that work with the organization to nine.

ResearchPoint launched its ResearchPoint Global network in 2004 as a way to expand its services across the globe through partner CROs. The company, which has two U.S.-based offices of its own, can conduct work in 65 countries through its ResearchPoint Global affiliates.

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German contract research organization (CRO) clinicalprojects is preparing to expand its services and global footprint in 2010, but founder Joerg Breitkopf said the company’s growth will be controlled.

Clinicalprojects does work in 10 European countries—the UK, France, the Netherlands, Poland, Austria, Switzerland, Italy, Spain, Portugal and Czech Republic—but only has an office in Germany. The CRO plans to open the company’s first foreign office in Italy in the first half of year. Breitkopf is still negotiating where the office will be located but said it will be near Milan.

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UK-based Chiltern International opened a new, larger office in Argentina, replacing the contract research organization’s (CRO’s) existing facility in that country. This is Chiltern’s fifth new office to open in the past year. The CRO opened offices in Hungary, Belgium, Scotland and Brazil in 2009.

The Buenos Aires office will be managed by Oscar Podesta, executive director, Latin America.  Podesta said the expanded office complements Chiltern’s Sao Paulo, Brazil, office and will support growing client needs in Mexico, Chile, Peru and all of Latin America. The company gained the Brazil office as part of its acquisition of CRO Vigiun last spring.

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Biologics, a cancer management company that offers clinical trial materials management as part of its services, has been selected by the National Marrow Donor Program (NMDP) to manage a phase III clinical trial.

Biologics’ Oncology Clinical Trial Services division will provide pharmacy management services for the nonprofit organization’s clinical trial of filgrastim (Neupogen)-simulated peripheral blood stem cells (PBSC) in hematopoietic cell transplants involving unrelated donors. PBSC, according to the NMDP, is used more often than marrow for adult patients in need of allogeneic and autologous transplants.

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Patient recruitment company BBK Worldwide  opened an office in Los Angeles to meet growing demand for patient recruitment services there and worldwide.

The company opened a Japan office in 2009, and this new West Coast location will help BBK better serve clients there and in the Pacific time zone. The company also has offices in Boston, London and Prague.

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Core laboratories RadPharm and Medifacts International recently merged business operations, hoping to attract new clients with their combined portfolios.

The deal, finalized Feb. 5, creates one company named CoreLab Partners (CoreLabs) with more than 400 employees (320 from RadPharm, 80 from Medifacts) and offices in New Jersey, Maryland, Germany and China. The new company’s main office is in Princeton, N.J.—RadPharm’s current headquarters.

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United BioSource Corporation’s (UBC’s) new office in Tokyo, Japan, is the company’s first office in that country and in all of Asia-Pacific.

The contract research organization (CRO), which has 21 offices worldwide, has conducted work in all of Asia-Pacific but did not have a legal entity there until now. UBC CEO Ethan Leder said the Japan office will have a staff of 12 by the end of this year, with almost all of those new to UBC. These employees will support UBC’s investigator training and certification services as well as ongoing clinical research monitoring in the region. UBC has 1,450 employees worldwide.

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