Quintiles to Partner with Japanese Lab Company Medca

Research Triangle Park, N.C.-based CRO Quintiles inked an agreement with Medca Japan, a laboratory testing and nursing care services company based outside Tokyo in Saitama, to use its lab to support clinical trials in the country. Medca Japan’s facility and staff are College of American Pathologists (CAP)-certified and its data will be available on Quintiles’ QNET database. Quintiles stated that Japanese regulations are changing in a positive way and are now allowing pivotal clinical trials to be conducted outside of Japan into the greater Asia region.

The challenge has been finding laboratories in the region that are “harmonized” with the same standards, the company stated. Quintiles now has central lab coverage in the Asia-Pacific region through a network of CAP-certified labs in Beijing, Singapore, Mumbai and now Japan.

Founded in 1974, Medca reported $340 million in revenue in 2007 and is also a medical supply manufacturer and distributor. It is also a leading pharmaceutical importer and seller in the country. The partnership is headed by Alan Ong, vice president and general manager, Quintiles Labs Asia, and Yoh Narimatsu, president, Quintiles Japan.

“We have established excellent systems for providing high-quality central laboratory services based on Quintiles’ global standard. We are determined to continue to increase clinical trials in Japan and provide superior services for our customers through this strategic business alliance,” said Narimatsu.

CWWeekly March 24th 2008 Issue

Top News

Medidata on Fast Track with First Acquisition

New York, N.Y.-based eClinical vendor Medidata Solutions purchased Fast Track Systems, a protocol design and study management software maker based in Pennsylvania. Fast Track’s chief executive officer, Ed Seguine, will become Medidata’s new general manager of trial planning solutions. The company’s chief technology officer, Peter Abramo-witsch, and vice president of operations, Lori Shields, will also join Medidata’s trial planning group. Fast Track’s offices in Conshohocken, Pa., and in Ross, Calif., will continue to operate. The company has 35 employees.

Project to Develop Guidelines for Health Research in Africa Launched

The “Clinical Trials Roundtable” attracted more than 70 participants during the “Science with Africa” conference organized by the United Nations Economic Commission for Africa (UNECA) and the African Union (AU), which is an international organization that promotes cooperation among the independent nations of Africa. The conference was held in Addis Ababa, Ethiopia, and attended by more than 600 stakeholders, including representatives from health and science ministries, universities, non-governmental organizations and international organizations from Africa, Europe and North America.

Other breaking news...      

• PRA International expands presence in India...
• OmniComm Systems in contract with Pleiad Devices...

Company Profile: An interview with Amanda Drake, founder and director, HUNT Services, LLC

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

Progenitor Grows Organically in Latin America, India

By Sara Gambrill

The opening of the Progenitor International Research’s new office in Buenos Aires, Argentina, a year ago signaled the beginning of a fundamental change to the company’s business model. Previously, Progenitor had worked exclusively as a CRO composed of teams in emerging markets who worked under a coordinated platform to deliver global development services. Progenitor’s office in Argentina represents the first organic growth of the company in an emerging market.

Progenitor International Research is an emerging market contract research organization (CRO) founded in 2005 with headquarters in Deidesheim, Germany. The company’s global management functions reside in Europe, and clinical research is conducted in 12 countries—Argentina, Chile, Peru, India, China, Korea, South Africa and countries in Southeast Asia.

Progenitor conducts clinical research in South Africa and in countries in Southeast Asia through partnerships, but the company is growing organically in the other countries in which it operates. The company has 800 clinical research professionals working together with Progenitor in emerging markets who have experience on more than 500 clinical trials.

CenterWatch caught up with three key members of the operations team at Progenitor International Research at the DIA EuroMeeting in Barcelona to find out how the new model was working and what plans the company had for growth in 2008 and beyond...

Bio-Imaging Technologies Acquires Phoenix Data Systems

By Stephen DeSantis

Newton, Pa.-based contract research organization (CRO) Bio-Imaging Technologies has opened up a new book of business with the acquisition of eClinical company Phoenix Data Systems. Bio-Imaging, which specializes in running trials that require medical imaging management, purchased the King of Prussia, Pa.-based company for $24 million, including $17 million in stock and $7 million in cash.

Following the acquisition, Bio-Imaging raised its revenue guidance range from $42 to $45 million to $52 to $55 million. It boosted its earnings guidance from 21 to 23 cents per share to 22 cents to 24 cents per share. The company reported service revenues of $38.2 million last year.

Crosstree Capital Partners acted as financial advisors on the deal.

For the near-term, Bio-Imaging plans to manage the company as a separate entity while it finds ways to leverage its core CRO business.  The company stated it will be looking for sales force, marketing and technology efficiencies. For now, Phoenix Data Systems will remain relatively unchanged. The company will keep its name and continue to be run by its current president, William Claypool, M.D. All 127 of its employees will remain part of the organization. 

“We do see tremendous opportunity, probably in the next year time-frame, to start to look at how we can do things more efficiently and grow more revenues without growing as many people,” said Mark Weinstein, president and chief executive officer at Bio-Imaging stated during a conference call...

Project to Develop Guidelines for Health Research in Africa Launched

By Sara Gambrill

The “Clinical Trials Roundtable” attracted more than 70 participants during the “Science with Africa” conference organized by the United Nations Economic Commission for Africa and the African Union, which is an international organization that promotes cooperation among the independent nations of Africa. The conference was held in Addis Ababa, Ethiopia, and attended by more than 600 representatives, including representatives from health and science ministries, universities, non-governmental organizations and international organizations from Africa, Europe and North America.

Two representatives from industry were also in attendance—Dr. Richard C. Hubbard, senior director, External Medical Affairs, International, Office of the Chief Medical Officer, Pfizer, and a representative from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents the global research-based pharmaceutical industry.

Much of the Clinical Trials Roundtable, chaired by Mrs. Avril Doyle, member of European Parliament, focused on identifying the needs of African countries for guidelines in clinical trials and other areas of health research. It also provided an opportunity for leading African and international partners to develop a consensus position on the organization of the project to develop guidelines for health research in Africa.

Francis Crawley, executive director of Brussels, Belgium-based Good Clinical Practice (GCP) Alliance, which he founded in 2005, was approached by organizers of “Science with Africa” in October to participate. Crawley has extensive experience in creating GCP guidelines and model bioethics laws in Eastern European, Asian and African countries. He was also asked to speak briefly at a meeting in the European Parliament in December and subsequently to write an abstract for the roundtable.

More than 70 attended the Clinical Trials Roundtable, which ran for four hours. About 80% of participants were from Africa and the rest were from Europe, the U.S. and Canada, according to Crawley. The industry representatives also participated. At a pre-meeting to the roundtable, African participants made it clear that, despite the existence of many international guidelines, Africa needed its own.

inVentiv Clinical Moves into Latin America

By Stephen DeSantis

inVentiv Clinical, the contract research organization (CRO) division of Somerset, N.J.-based marketing, communications and staffing firm inVentiv Health, has expanded its clinical services to Latin America with a new central hub in Sao Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

inVentiv Clinical has placed Ana Paula Ruenis, Ph.D., in charge as director of clinical operations in Latin America. Ruenis has more than eight years of experience managing trials in Latin America and has worked for top pharmaceutical companies in South America.

"Having already established full off-shore operations in India, the expansion of our clinical operations into Latin America is an important next step in our goals to become a global clinical services provider," said Mike Hlinak, inVentiv Clinical’s chief executive officer.

Latin America has proven to be an emerging market of choice of late. It poses less of a logistical challenge than do more remote regions such as China and India. The six major markets—Argentina, Brazil, Chile, Colombia, Mexico and Peru—have 425 million people, or 80% of the region’s population. That is equal to the population of the entire European Union but less than half the size of India or China.

CWWeekly March 17th 2008 Issue

Top News
 
Global Research Services Expands in China

Maryland-based Global Research Services (GRS) has expanded its China operations and will now offer full clinical trial services to its clients there. The company, through its subsidiary Global Medical Consulting Services in Shanghai, will provide monitoring, site selection, project management and data management. Prior to the expansion, the office, originally set up in 1996, offered data management.

Clinical Research Advantage Adds 11th Research Site

Phoenix, Ariz.-based site management organization (SMO) Clinical Research Advantage has added Phoenix-based general practice research site Tatum Highlands Medical Associates to its network. Clinical Research Advantage will handle overall study management, regulatory, budgets, business development and ongoing quality assurance. Clinical Research Advantage has 48 employees. In February 2007, a private investment group put money into the company and began an expansion program.

Other breaking news...      

• etrials’ reports $2.6 M loss...
• Cato names John Cline as president...

Company Profile: An interview with David Williams, chief executive officer, Clinsys Clinical Research

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

PRA Relocates to Larger India Office

Raleigh, N.C.,-based PRA International has expanded its Mumbai, India, presence by moving into a larger facility. It is located in a new development in the Andheri East area of Mumbai. The new space can hold more than 20 clinical staff and allow for PRA to bring its total to 50 employees there by the end of the year. The company said this would potentially increase its service capacity by 150%. As the office grows, PRA will increase services in protocol development, medical writing and clinical consultation services in the region.

"This is an exciting time for PRA," said Dr. Sue Stansfield, executive vice president, Product Registration, Europe, Africa and Asia-Pacific. "The Mumbai team is a great example of PRA's global experience and therapeutic expertise.  Their success in earning client trust and delivering service excellence has been key to the growth we are experiencing in India."

eClinical Technology News

Ft. Lauderdale, Fla.-based OmniComm Systems won a contract from Pleiad Devices, a medical device focused contract research organization. OmniComm will become a preferred vendor for Pleiad. The company will use OmniComm’s electronic data capture (EDC) product TrialMaster, initially for a trial studying an eye treatment. "Over the years, our team has had experience with most of the EDC vendors in the marketplace. TrialMaster is one of the best EDC products that we have seen and we look forward to offering our medical device customers this premier service," stated Stephen Brandao, vice president of business development at Pleiad Devices.

UK-based ClinPhone launched a combination EDC and interactive voice response and interactive web response (IVR/IWR) product to help its clients eliminate costs associated with integrating such technologies separately. The EDC component will be DataLabs – the company’s EDC solution obtained through the acquisition of DataLabs in late 2006 – combined with its IVR/IWR solutions for trial management and electronic patient reported outcomes (ePRO) needs. ClinPhone stated the new product guarantees the data that is shared between the two systems will be accurate via the company’s Connect integration platform.

Waltham, Mass.-based CRF has updated its ePRO software product TrialMax to be used on Tablet PC-based eDiaries running Window’s Vista. While the company stated the use of portable devices has created great benefit to its clients, it also sees the advantages of using Tablet PCs for some studies, and with certain patient populations. All of the company’s TrialMax capabilities -- including TrialManager and TrialStudio -- will be supported by all three device types.

Maryland-based clinical technology company Xceleron launched META-ID, a product designed to help clients comply with the FDA guidelines regarding Safety “Testing of Drug Metabolites”. The guidelines were published in February 2008 and seek to encourage more research into a drug’s metabolic differences between preclinical test species and humans. The company stated the product can be integrated into phase I studies already underway and deliver data within two weeks.

Oracle Clinical unveiled a new version of its EDC solution called Oracle Remote Data Capture Onsite 4.5.3. The enhanced product offers new functions geared toward helping investigative site personnel work more efficiently with upgrades such as new spreadsheet displays of multiple case books and edit check capabilities. The company cites industry experts who believe that investigative sites have not traditionally had their voices heard. 

Waltham, Mass.-based Phase Forward released Empirica Trace, an enhanced version of the company’s current adverse event reporting product Clintrace. The new product will bring together Clintrace’s capabilities with the company’s pharmacovigilance and risk management solutions. The product will be managed by Phase Forward’s Lincoln Safety Group. The product is web-based and will provide clients the ability to collect, analyze and report adverse events as well as handle global report distribution, quick data entry and MedDRA query support.

Cambridge, Mass.-based clinical management software provider PharmaPros unveiled its new product Electronic Data Lifecycle Management (eDLM) designed to manage information gathering during clinical research. The company stated its eDLM uses proprietary data integration technology to provide tracking and reporting functionality easily within client’s own systems. The tool allows clients to “orchestrate” this process from various data repositories and from multiple vendors, a capability that is becoming necessary within the industry.

CenterWatch Monthly March 2008 Issue

Unanticipated Problems Reporting Adverse Events to IRBs

FDA regulations governing adverse event reporting and IRBs have become outdated. At a time when clinical research is increasingly being conducted abroad and clinical trials are growing larger and more complex, IRBs are being inundated with single adverse event reports, which they have neither the resources nor the expertise to analyze. In recognition of this growing problem, both OHRP and FDA issued guidance last year. FDA has recognized and more narrowly defined the IRB’s role in clinical research oversight and underscored the necessity for sponsors to send IRBs analyzed reports on the data, in its draft guidance. Sites are caught between IRBs’ own clear reporting guidelines and sponsors taking a conservative position and demanding that sites report all adverse events to the IRB.

Global Growth Story Remains Strong for CROs in 2008, Beyond

Contract research organizations (CROs) report strong growth across all phases of drug development as cancellation rates remain at historic lows. Public CRO shares remain a strong sector in a shaky stock market as CROs report consistent revenue and profit growth. Global CROs are in a strong position in the industry as they solidify their leadership in global clinical trials in emerging regions. CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and a few others are well positioned with global infrastructures in place to continue handling global growth.

Addressing the Shortage of Skilled Clinical Researchers in Europe

Difficulties finding and keeping suitably qualified clinical trials personnel have intensified in Europe. Observers agree that the available workforce simply isn’t large enough to meet staffing needs. The result has been spiraling salaries, as experienced professionals—and even relatively new recruits to the industry—capitalize on the staffing shortfalls.

Eye On Prostate Cancer

Second only to skin cancer, prostate cancer is the most common cancer, according to the American Cancer Society. In the United States, it is also the second most frequent cause of cancer-related death in men (after lung cancer), with approximately 30,000 men dying each year from the disease. CenterWatch has identified a pipeline of 23 pharmacotherapeutic agents in various stages of development for prostate cancer. Many of these affect either hormonal or immunological pathways, whereas others are novel formulations of more traditional chemotherapeutic agents.ch year from the disease.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

Recent Industry Personnel Changes

Contract Research

Raleigh, N.C.-based contract research organization (CRO) INC Research hired Richard Williams to serve as vice president of the company’s regulatory services. He will help lead the strategic consulting group and all other global regulatory activities. Prior to INC, Williams worked in senior regulatory positions at Merck and Pfizer.

UK-based CRO Premier Research Group hired Sebastien Duval to become the company’s business development director based in France. Prior to joining Premier, Duval was senior business director at the preclinical CRO, CIT. He has also held positions at Chiltern, Parexel and CEREP.

Waltham, Mass.-based CRO Parexel appointed Jacque Fisher to the position of vice president and general manager for its Medical Communications Services division. Fisher will head a group that assists Parexel’s clients to translate scientific information into less complex communications and will advise customers on their communications programs. Prior to joining the company, Fisher was president of Gardiner-Caldwell U.S., a former business unit of Thomson Healthcare. She also held senior-level positions at Page & Moy Marketing in the U.K.

Technology

Waltham-based eClinical company Phase Forward appointed Russ Campanello to senior vice president of human resources and administration. Campanello was the senior vice president at Keane, a worldwide tech consulting firm. Prior to Keane, he held senior roles at NerveWire and Genzyme.

BioPharma Services

Bethesda, Mary.-based United BioSource Corporation expanded its Ann Arbor based regulatory affairs group with the additions of Mark Ammann, Pharm.D., and LaVonne Lang, Dr. PH. Both Ammann and Lang are former regulatory executives at Pfizer.

CWWeekly March 10th 2008 Issue

Top News

AbCRO Opens Two Offices in Russia

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened two offices in Russia. AbCRO currently has 170 employees. AbCRO also has offices in Bucharest and Cluj, Romania; Zagreb, Croatia; and Belgrade, Serbia. In addition, the company opened an office in Warsaw, Poland, last year.

PRA Doubles Kansas Phase I Unit

Raleigh, N.C.-based contract research organization (CRO) PRA International has opened a new clinical pharmacology unit (CPU), adding about 40 beds in Lenexa, Kansas.The facility replaces a smaller nearby phase I unit and doubled PRA’s presence in the area to 80 beds. The 16,000-square-foot facility was built at a cost of about $2 million. According to Tamminga, the new CPU in Kansas will focus on “high-end” complex trials that require a lot of skill and knowledge to perform.

Other breaking news... 

• GRS launches phase I data management platform...
• Georgia Institute of Technology develops drug compliance device “necklace”...

Company Profile: An interview with Ron Waife, president, Waife & Associates

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

Japan’s New Regulatory Attitude Evident at DIA EuroMeeting

By Sara Gambrill

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

What he went on to say was both surprising and refreshing, coming from a representative of PMDA. He said that he had wondered what he would wear if he didn’t get his luggage in time for the session. In the end, even though he had been reunited with his clothing in time, he decided to wear the PMDA T-shirt to foster an informal atmosphere for the session, which he hoped the audience would find acceptable. This last sentiment was met with an enthusiastic round of applause from the hundreds in attendance, many from big pharma.

Clearly the message PMDA wanted to send during its session was that the agency is striving for openness, cooperation and timeliness to promote Japan’s role in global drug development.

Both Uyama and Satoshi Toyoshima, Ph.D., executive director and director, Center for Products Evaluation at PMDA, discussed many objectives and initiatives to accelerate the drug process in Japan, but the initiative that will have the most immediate impact will launch in April. With the new Investigational New Drug Application (IND) Consultation Process, PMDA wants to increase the number of face-to-face meetings with sponsor companies and also meet with them in a more timely manner.

Uyama noted that in 2006 there were 473 sponsor applications for IND consultations with PMDA, with only 295 actually granted. PMDA wants to increase the percentage of consultations granted to those sponsors that apply and has a tentative plan that Uyama shared with the DIA EuroMeeting audience. From April forward, the new IND consultation process should have a predictable schedule of about five months, during which sponsors are able to submit an expression of intention, apply and submit documents to PMDA.

Five weeks prior to the face-to-face meeting, there will be an inquiry and response period between sponsors and PMDA. Four days prior to the face-to-face meeting, PMDA will give its opinion, which will be discussed at the meeting. Draft minutes will be drawn up and then finalized one month after the meeting.

RLS Drug Shows Promise in Pivotal Trial

XenoPort and GlaxoSmithKline reported positive top-line results from a phase III trial of XP13512, a gabapentin pro-drug with enhanced absorption, for the treatment of moderate to severe restless legs syndrome. This 12-week, double-blind, placebo-controlled study, dubbed XP053, enrolled 325 subjects. The endpoints were met with statistical significance in both dose groups when compared to placebo.

The subjects received placebo or 600 mg or1, 200 mg of XP13512, given once per day. The primary endpoints were the change from baseline for the International Restless Legs Syndrome (IRLS) rating scale score at end of treatment and the percentage of subjects showing significant improvement on the Investigator Clinical Global Impression of Improvement (CGI-I) scale at end of treatment.

In the 600 mg dose group, the unadjusted mean reduction in the IRLS scale score was -13.8 (p less than 0.0001). 

At the end of treatment, 73% of subjects treated with 600 mg of XP13512 were reported as “much improved” or “very much improved” on the CGI-I scale (p less than 0.0001 compared with placebo). In the 1,200 mg dose group, the unadjusted mean reduction in the IRLS scale score was -13.0 versus -9.8 for placebo (p=0.0015).

At the end of treatment, 78% of subjects treated with 1,200 mg XP13512 were reported as “much improved” or “very much improved” on the CGI-I scale compared with 45% treated with placebo (p less than 0.0001). Treatment was generally well tolerated, with adverse events mild to moderate.

An New Drug Application (NDA) filing is planned for the third quarter of this year.

In February 2007, GlaxoSmithKline and XenoPort entered into an exclusive development and commercialization collaboration for the drug.

etrials' Reports $2.6M Loss

Morrisville, N.C.-based etrials’ sales were up 17% during its 2007 fourth quarter. The eClinical company reported net service revenue was $4.9 million compared with $4.2 million in 2006. However, it reported a net loss for the fourth quarter of $2.6 million (or $0.24 per diluted share) compared with a net loss of $46,000 (or $0.00 per diluted share) in the fourth quarter of 2006.

The company stated its business costs rose substantially across the board, signifying it is investing heavily to return the firm to profitability. The fourth quarter included a $1.75 million charge it paid for a litigation settlement for a patent infringement case with software developer Datasci.

Net service revenue for the year was up 18%, with $18.3 million reported in 2007 compared with $15.5 million the prior year. etrials reported a loss of $6.2 million (or $0.57 per share)  compared with a $1.8 million loss (or $0.18 per share) in 2006.

The company stated costs were up significantly in all areas. Its sales and marketing costs also rose, partly due to new sales recruitment initiatives. Its R&D spending jumped 21%.also related to personnel costs. All told, $2.8 million was attributed to "increased personnel and related costs."

"Since mid-2007, we have made a number of key strategic senior management hires, made significant personnel upgrades, added a client services practice, and completely reorganized our sales organization to more effectively apply the expertise necessary to match our client needs. Further, we upgraded our IT infrastructure to ensure data performance, capacity, quality and security to position the company for long term growth," said Chip Jennings, president and chief executive officer of etrials.

etrials did, however, state its new project bookings were $7 million compared with $4.9 million in the third quarter of 2006, up 37% compared with the fourth quarter of 2006. The company was awarded 20 new contracts in 2007, including four from new customers.

"Even with our substantial progress, there is still much work to be done and more time required for these initiatives to wholly permeate the organization," added Jennings.

etrials stated it did not expect to benefit substantially from these investments until 2009.

CWWeekly March 3rd 2008 Issue

Top News

Aris Global Boosts CTMS Offerings

Aris Global has made another big move into the clinical trials management system (CTMS) space with the launch of two new products, agClinical and agClinical NW. The products were unveiled at the 2008 Clinical Trials Congress last week in Orlando, Fla. Aris has a well-known suite of adverse drug event reporting and regulatory software.

PharmaNet 2008 Outlook Cut Amid Strong CRO Growth

Contract research organizations (CROs) had a great run in the past year, but PharmaNet Development Group’s weak guidance for 2008, issued on Feb. 28, sent its shares tumbling more than 30%. That raises concerns about a possible pullback for the clinical trials industry following a strong year.

Other breaking news... 

• D. Anderson opens new UK office...
• SCRI adds The Frist Clinic to partner network...

Company Profile: An interview with Scott Singer, president and chief executive officer, Effective Research

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

EDICT Project Opens Policy Recommendations For Public Comment

The EDICT project, short for Eliminating Disparities in Clinical Trials, has invited the public to comment on a series of policy proposals design to help patient recruitment and retention in clinical trials. The period open to public comment runs until March 21.

Shortly after, the final policy recommendations will be brought before the Congress, the National Institutes of Health and the Food and Drug Administration.

Among the issues the policies address are minority participation, patient insurance, informed consent, and standards and accreditation. EDICT is a collaborative alliance between Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center and the Intercultural Cancer Council (ICI). It consists of researchers, public health officials, patient advocates and other various stakeholders.

The four-year project is supported by an unrestricted grant from Genentech.

AbCRO Opens Two Offices in Russia

By Sara Gambrill

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened two offices in Russia.

The St. Petersburg office has three employees and will be in charge of operations, while the Moscow office has one person and runs regulatory affairs. AbCRO has one active oncology clinical trial in Russia now and is bidding on others.

“Russia is the biggest country in our region. We had an existing client base that was interested in working with us if we had operations in Russia, so we decided that it was time that we did,” Dana Leff, chief executive officer of AbCRO, told CWWeekly at the DIA EuroMeeting in Barcelona. 

AbCRO was founded in 1999 and had two employees with an office in Sofia, Bulgaria, and a marketing office in Stamford, Conn. From 2001 to 2006, the company grew strongly, nearly doubling its employees between 2005 and 2006. “Between 2006 and 2007, our revenues more than doubled and our staff increased by about 60%. Our projections for revenue growth this year are about 60%,” said Leff.

AbCRO currently has 170 employees. AbCRO also has offices in Bucharest and Cluj, Romania; Zagreb, Croatia; and Belgrade, Serbia. In addition, the company opened an office in Warsaw, Poland, last year.

The company also has a clinical research associate in Kiev, Ukraine, with plans to open an office there soon. AbCRO has always had a business model that required clinical research associates to be full-time employees, which differentiates the company from some other CROs in the region.

Leff added that the company is planning to conduct feasibility studies in Azerbaijan. That country´s capital city, Baku, has a population of about 4 million and has good infrastructure. Azerbaijan’s average income levels are also a bit higher than those of neighboring countries.

Sara Gambrill, senior editor at CenterWatch and author of The Emerging Markets of Clinical Research.

CWWeekly January 25th 2008 Issue

Top News      

Parexel Pursues ClinPhone in Takeover Bid

UK-based eClinical company ClinPhone rejected a preliminary takeover offer from Parexel International, a contract research organization (CRO) based in Waltham, Mass. Although financial details were not disclosed, ClinPhone said it considered the offer too low.

Interspond Merges with Paramount Research Consortium

Madison, Wis.-based trial management organization (TMO) Interspond has merged with Paramount Research Consortium, a TMO based in Wisconsin Rapids, Wis. Interspond works with a network of 140 multi-therapeutic sites that it services in a nonexclusive relationship model. Unlike Interspond, Paramount operated under a site membership model. Sites paid a monthly fee to the company in exchange for business development services

Other breaking news...      

ICON reports big fourth quarter revenue increase...
ACS launches new version of its CTMS product...      

Company Profile: An interview with Faye Woolf, chief executive officer, and Betsy Brown, chief operating officer, Trio Clinical Research