Mozibil Increases Stem Cell Count in Phase III Trials

By Tracy Trundle

Genzyme reported positive results from a phase III trial of Mozobil (plerixa), a CXCR4 chemokine antagonist, as an agent for increasing the number of hematopoietic stem cells collected for stem cell transplantation procedures for the treatment of various cancers.

This randomized, double-blind, placebo-controlled trial enrolled 298 subjects undergoing a hematopoietic stem cell transplant (HSCT) for non-Hodgkin's lymphoma, in the U.S. and Canada. The trial was designed to compare the hematopoietic stem cell yield from subjects treated with Mozobil in combination with granulocyte-colony stimulating factor (G-CSF, standard of care) to subjects treated with G-CSF in combination with placebo.

The primary efficacy endpoint was achieved, with 59% of the subjects in the Mozobil arm reaching the target threshold for collection of at least 5 million CD34+cells/kg from the peripheral blood with four or fewer days of apheresis sessions, compared with 20% in the placebo arm (p<0.0001). The secondary endpoint also reached statistical significance, with nearly 87% of the subjects in the Mozobil arm minimum level of stem cells generally associated with a successful transplant (2 million CD34+cells/kg) in four or fewer days of apheresis sessions, compared to 47% in the placebo arm (p<0.0001).

Genzyme aquired the rights to Mozobil through the purchase of AnorMED in November 2006. It plans to file for U.S. and European approval for lymphoma in the first half of 2008.

Tracy Trundle is a Research Analyst at Thomson CenterWatch.

PRA International Agrees to Genstar Capital Buyout

By Stephen DeSantis

In a move that will take Reston, Va.-based contract research organization (CRO) PRA International off the public market, the company has entered into an agreement to be purchased by Genstar Capital, a private equity group based in San Francisco. The deal is valued at $790 million.

If the deal is completed, shareholders would receive a cash buyout of $30.50 per common share. That would be a 24% premium over PRA’s average closing price for the last three months.

During a conference call, PRA executives said that Genstar will invest in the company to accelerate plans for expanding the firm’s service offerings and broaden its geographic footprint.

In response to an analyst’s question, Terrance Bieker, chief executive officer of PRA, said its board of directors came to the conclusion that the right course of action was to provide its shareholders with an immediate premium on their investment.

Some analysts on th call questioned the current buyout, stating that PRA was already on course to surpass its premium buyout offer of $30.50 per share, especially given the company’s last few quarterly earnings.

-Read more on the acquisition in this week's issue of CWWeekly.

Top Stories for the Week of July 23rd 2007

Top News

Premier Research Group Acquires ARS and D-Target

London-based contract research organization (CRO) Premier Research Group made its fifth and sixth acquisition since going public in 2004 with the purchase of two CROs. Premier acquired Wareham, Mass.-based ARS and D-Target, a medical device-focused CRO based in Switzerland.

eResearchTechnology Starts ePRO Line

Philadelphia, Pa.-based clinical technology firm eResearchTechnology (eRT) made its entrance into the electronic patient reported outcomes (ePRO) market by partnering with Healthcare Technology Systems (HTS).

Other Breaking News:

• Constella Group finds partner in India...
• RTI opens office in Spain...

Company Profile: An interview with Peter Bechtel, president and chief executive officer, eCast

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

Phase Forward Revenue, Profits Jump

By Steve Zisson

Waltham, Mass.-based Phase Forward, a provider of electronic data capture (EDC), drug safety and data management solutions for clinical trials, reported second quarter revenues rose 28% to $31.5 million and profits doubled.

At mid-day, Phase Forward's shares were up 11% to $18.18.

For the second quarter, income from operations increased 89% from the prior year period to $4.5 million, resulting in a 14.4% operating margin. Net income for the period was $5.6 million, or $0.14 per diluted share, compared with $2.7 million, or $0.07 per diluted share, in the second quarter of 2006.

License, application hosting and other related revenues increased 39% to $22.8 million from $16.3 million in the prior year period, representing 72% of second quarter 2007 total revenues.

"We are pleased with the company's performance during the second quarter, which was highlighted by major customer wins, new and expanded partnerships with contract research organizations (CROs), a breakthrough technology introduction and an increase in the level of competitive replacement activity. We continue to be encouraged by the overall strength of market demand for EDC and safety solutions, which is reflected in our increased outlook for bookings in 2007," said Bob Weiler, chief executive officer and president of Phase Forward.

During the second quarter, a top 10 pharmaceutical company expanded its adoption of Phase Forward’s EDC solution into a multi-year, multi-million dollar application services provider commitment.

“We believe the increasing adoption of EDC by the world's largest pharmaceutical companies adds further pressure on other companies to make similar investments or risk being at a competitive disadvantage. Phase Forward is benefiting from this trend due to our customer reference ability, proven scalability, global service and support infrastructure, as well as the breadth and depth of our products' functionality. In addition, our recently introduced Central Designer(TM) application can help customers shorten the EDC study design and build process more effectively, improving operational efficiencies and reducing the barriers to adoption for customers of all sizes," Weiler added.

Steve Zisson is managing editor at Thomson CenterWatch.

Serbia Celebrates International Clinical Trials Day; Clinical Center of Serbia Joins ECRIN

By Dragana Maca Kastratovic, M.D.

In May, the celebration of the “International Day of Clinical Trials” was organized by the Center for Clinical Pharmacology, Clinical Center of Serbia, in the Polyclinic of the CCS. The International Day of Clinical Trials is May 20, which commemorates the first comparative trial conducted in 1747 on 12 sailors afflicted by scurvy.

On behalf of the Clinical Center of Serbia, the meeting was opened by Professor Dr. Svetozar Damjanovic, a Scientific Research Manager. His introductory lecture was called “The significance of clinical trials for the development of the Clinical Center of Serbia.”

Professor Damjanovic reported on past activities and results in respective fields, as well as the huge potential for the future. He emphasized that, by implementing the EU Directive for Clinical Trials, Serbia would have a chance to work in the same way as the best research settings in Europe and worldwide.

The European Union Clinical Trial Directive was passed by the Ministry of Public Health of the Republic of Serbia and incorporated in the Serbian Act, which encompasses the regulations governing clinical trials of drugs, procedures and contains the documents for approval of clinical trial, Official Gazette No 19/2007.

Thus, clinical trials in Serbia will be performed officially in the same way as in other EU countries. Dr. Vasilije Antic, senior consultant gave a presentation on this Act with a special focus on the part referring to inclusion of vulnerable populations into clinical trials of drugs.

Type II Diabetes Drug Fails Primary Endpoint

By Tracy Trundle

Metabasis and Daiichi Sankyo issued negative results from a phase IIb trial of CS-917 for the treatment of type II diabetes. This multi-center, double-blind, placebo-controlled trial enrolled 392 subjects who were divided into four treatment arms to receive CS-917 at 50 mg BID or 100 mg BID, metformin at 850 mg BID or placebo, for three months. 

Both doses of CS-917 failed to meet the primary endpoint of significantly lowering the placebo-adjusted level of glycosylated hemoglobin (HbA1c), a measure of glucose load.

The mean HbA1c level at the start of the study was approximately 7.6-7.7%. The placebo adjusted HbA1c level at the end of treatment was unchanged at the CS-917 low dose and there was a 0.17% decrease at the high dose (p=0.1256). Metformin treatment resulted in a placebo-adjusted decrease of HbA1c of 0.50% (p less than 0.0001).

Metabasis and Daiichi Sankyo plan to fully evaluate the data to determine a future course of action. CS-917 is being being developed by Daiichi Sankyo through a licensing agreement between Metabasis and Daiichi Sankyo.

In a statement by, Dr. Mark Erion, executive vice president of research and development and chief scientific officer at Metabasis Therapeutics said:

"We are surprised and disappointed by the results we have seen so far in this important Phase 2b clinical trial, especially after the promising preclinical and early clinical results from smaller 14-day and 28-day studies."

The company stated their were many unanswered questions raised by the trial.

"For example, the fasting plasma glucose levels and HbA1c levels in patients at the start of the Phase 2b trial were substantially lower than were studied in the previous Phase 2a clinical trials. We want to explore if this could have impacted the results. This is but one of many factors we plan to evaluate. We expect to work closely with Daiichi Sankyo over the coming weeks to analyze and compare the outcomes of this and previous trials. These efforts may help the Metabasis team to determine the impact of these findings on CS-917 and the gluconeogenesis inhibitor class of drug candidates, including MB07803," said Erion.

Tracy Trundle is a Research Analyst at Thomson CenterWatch.

Kendle Raises $200 Million Through Convertible Senior Note Offering

Cincinnati, Ohio-based Kendle International has closed a $200 million offering of convertible senior notes, which would become due in 2012. The notes would be converted into a combination of cash and common stock.

Kendle stated it would use the majority of the proceeds (approximately $146 million) for repayment of debt and general corporate purposes, including “working capital and acquisitions or investments in businesses, products or technologies complementary to its own.”

Kendle also entered into convertible note hedge transactions, intended to reduce any dilution to the company’s shareholders upon future conversion of the notes. The offering is being handled by UBS Investment Bank. Kendle reported revenues of $373.94 million last year.

Fraudulent Study Broker Cherie Thibodeau Continues to Bilk Sites

As a public service to sites, CROs and biopharmaceutical companies, CenterWatch is posting a long excerpt of this week’s CWWeekly article about fraudulent study broker, Cherie Thibodeau.

If you have been defrauded of funds by Cherie Thibodeau, please contact CenterWatch at cw.editorial@thomson.com.

By Sara Gambrill

Cherie Thibodeau, who operates under multiple aliases and claims to be an M.D. in her solicitations to investigative sites, CROs and biopharmaceutical companies, has bilked at least one more site out of almost $5,000 since CWWeekly published its last article about Thibodeau in February.

In the latest case, Thibodeau sent a solicitation by fax last October to Partners in Research, LLC, an Akron, Ohio-based site, to which it responded. Thibodeau followed up with a telephone call about a diabetes study study sponsored by Novartis, and within two weeks, the site was chosen to participate in that study, according to Colin Moorhead, M.D., president of Partners in Research.

Some of the terms of the agreement that the site signed with Thibodeau, who was listed as Dr. Cherie Thibodeau, M.D., Ph.D.,” were that she would handle administrative tasks, such as regulatory documentation, marketing and advertising, for the site. For that work, she would take 10% of the revenue from any study she brokered for the site and the same percentage for any study the site was able to get on its own. But after months of working on the initial study, the site had not received reimbursement from Thibodeau, even though she had been paid by the sponsor.

“Around February, it was starting to get hard to get a hold of her or get her to respond…We’ve already had a couple of patients screened and a patient enrolled in the [diabetes] study and we’re wondering when do we expect some reimbursement?” said Moorhead.

Partners in Research continued to conduct the study and a few months later, the site was able to get a study on its own from Merck...

Top Stories for the Week of July 16th 2007

Top News

Fraudulent Study Broker Cherie Thibodeau Continues to Bilk Sites

Cherie Thibodeau, who operates under multiple aliases and claims to be an M.D. in her solicitations to investigative sites, CROs and biopharmaceutical companies, has bilked at least one more site out of almost $5,000 since CWWeekly published its last article about Thibodeau in February.

ICON Acquires Staffing Company DOCS

Dublin-based contract research organization (CRO) ICON has acquired clinical staffing firm DOCS International, based in the Netherlands, for approximately $40 million. The 350-employee firm was founded in Amsterdam in 1997 and operates solely in Europe, offering services to eight European countries, including the UK and Poland.

Other breaking news...      

• CCF wants to increase enrollment...
• Quintiles consolides central labs...

Company Profile: An interview with Shelagh Verco, co-founder and senior vice president, Stiris Research

India to Allow First-in-Human Phase I Studies of Molecules Developed Abroad Soon?

By Sara Gambrill

India may allow first-in-human phase I studies of molecules developed abroad in the near future. Currently, India only allows first-in-human studies developed in India—a boon to the burgeoning domestic clinical research industry, and a bane of the global clinical research industry.

A year ago, the then Drug Controller General of India, Mr. Ashwini Kumar, said at the DIA Annual Meeting in Philadelphia that India was not ready for these types of studies. Some wonder if India is ready now.

CenterWatch spoke with Navaneetha Rao for perspective. Rao has worked in India for many years and is currently head of clinical R&D at Vicus Therapeutics, a small U.S.-based biotech. Prior to that he worked for an India-based contract research organization (CRO), as head of clinical research services.

“Imagine if what happened in the UK with TeGenero were to happen in India. Not only would it have a huge negative and adverse impact on phase I studies, but it would have a very big dampening effect on clinical research in general. There are right things happening, there are right steps being taken, but is it sufficient to handle the load that is being placed on the industry?”

The Central Drug Standard Control Organization, India’s main regulatory agency headed by the DCGI, promulgated “Good Clinical Practices for Clinical Research in India five years ago, and it’s been two-and-a-half years since India upgraded its Schedule Y (equivalent to the U.S. Code of Federal Regulations) to harmonize it with U.S. and International Conference on harmonization (ICH) standards.

India’s participation in global clinical trials nearly quintupled between 2001 and 2005, but it is in competition with other emerging markets, all of which allow first-in-human phase I clinical trials for molecules developed outside their respective countries...

Recent Industry Personnel News

• London-based CRO Premier Research Group hired David Fitts, MPH, Ph.D as executive director, biostatistics. Fitts comes to Premier from EMD Pharmaceutical, part of German-based Merck KGaA, where he was vice president of the clinical R&D unit’s global biostatistics and data services group. Fitts will now be responsible for all of Premier biostatistics operations in the U.S.

• Synomics Pharma Services, a Wareham, Mass.-based analytical services CRO, appointed John Pirro as vice president and chief operating officer. Prior to Synomics, Pirro was vice president and general manager of MDS Pharma Service’s North American bioanalytical unit. Pirro has also held positions at Charles River Laboratories, Bayer and Bristol-Myers-Squibb.

• Pharm-Olam International, a Houston-based CRO, hired Sean Alan Reade as vice president of global regulatory affairs. Reade was most recently director of regulatory affairs at PPD. He also was vice president of regulatory affairs at UCB/Celltech.

• Boston, Mass.-based CRO Parexel’s technology unit, Perceptive Informatics, appointed Wade Wirta to vice president of group’s clinical IVRS (interactive voice response systems) business. Wirta was with Pfizer for 13 years, most recently as its director of supply chain informatics group.

• Symyx Technologies, a research & development software provider, appointed Gerard Abraham as president of the company’s research support software, Symyx Tools.

• Holmes Biopharma appointed Mark Slama to the position of associate director of clinical operations for the company’s CRO subsidiary, Qualia Clinical Services. Slama joined Holmes Biopharma from MDS Pharma Services where he held several clinical management positions.

• Cheryl Ray, M.D. was appointed as a scientific adviser to Oregon-Wis.-based CRO Next Generation Clinical Research. Ray is the founder and president of Madison Institute of Neurological Disorders, or the “The Mind Group.”

Be sure to send your organization's latest personnel news via email to the editors at Clinical Trials Today!

CenterWatch Monthly: July 2007 Issue

Radiant Research Leads Global Change in Site Management Market

Radiant Research has claimed profitability nearly every year since it was founded in 1998. The company has grown not only through a series of acquisitions, but also by expanding existing facilities and opening new centers. Radiant is embarking on a new global growth period with the backing of a private equity group, which took ownership in June. Radiant, which has trimmed itself down to 26 owned sites, plans to take its SMO model worldwide. Other SMOs, of varying models, continue to be successful, following the niche's slide when many SMOs exited the market.

Positive Volunteer Experience Holds Steady in New CenterWatch Study

More than 90% of study volunteers say their experiences were good enough in a clinical trial that they would participate again. Despite all of the bad press about the pharmaceutical industry, study volunteers remain steadfast in their support of trial participation. CenterWatch surveyed 620 study volunteers across the United States in April and May 2007 on issues such as how they learned about the study, which factors influenced their decision to participate, and how well they understood study expectations. More than half of respondents had participated in a study this year or in 2006.

German Research Down But Far From Out

Germany has been struggling in the increasingly global clinical trials industry. A report last year by the Fraunhofer Gesellschaft research institute showed that while the significance of Germany as a venue for R&D has diminished since the early 1970s, major competitors, such as the U.S., Japan, France and the UK, have taken a larger slice of the global pie.

Eye On: Respiratory Diseases

Respiratory diseases encompass a broad spectrum of pathology including chronic obstructive pulmonary disease (COPD), asthma, and other conditions characterized by airway blockage or narrowing; restrictive lung diseases such as idiopathic pulmonary fibrosis; and a host of infections acquired both in the community and in the hospital. CenterWatch has identified a pipeline of 21 drugs in different phases of development for respiratory diseases. Several target airway inflammation via immune system cells; others act as novel bronchodilators; and various antibiotics address the problems of microbial resistance and opportunistic infections.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

DepoMed Sees Negative Results from Controlled-Release Gabapentin

By Tracy Trundle

DepoMed reported negative results from a phase III trial of Gabapentin GR for the treatment of postherpetic neuralgia (PHN). The product is a twice-daily, controlled-release tablet formulation of the anticonvulsant and analgesic gabapentin.

This randomized, double-blind, placebo-controlled trial enrolled 407 subjects who were placed into one of three treatment groups to receive Gabapentin GR once daily, Gabapentin GR twice daily (each 1800 mg/day) or placebo for 10 weeks.

The primary endpoint was the reduction in average daily pain scores from baseline to endpoint with Gabapentin GR compared to placebo. Statistical significance was not reached for either active treatment group. The average daily reductions were 1.83 (once daily), 1.72 (twice daily) and 1.43 (placebo). However, statistical significance was achieved in all the secondary endpoints, including Clinical Global Impression of Change (p less than 0.001) and Patient Global Impression of Change (p=0.009).

DepoMed plans to fully evaluate the data in order to determine a future course of action.

Tracy Trundle is a Research Analyst at Thomson CenterWatch.

Encorium Group Scores $1.7 million Phase II Contract

Wayne, Pa.-based CRO Encorium Group has inked a $1.7 million deal to manage a phase II trial in major depressive disorder for an unnamed biotech company based in Japan. Encorium will provide site management and monitoring, data management, biostatistical support and medical writing for the study. Encorium stated it intends to pursue further opportunities in the Japanese market and has made that market one of its key long-term business strategies. Recently, the company signed a $3.8 million contract to conduct phase IIb clinical trials with a new antiviral agent for the treatment of shingles (herpes zoster).

Top Stories for the Week of July 9th 2007

Top News

Criterium Opens Offices in Russia, Israel

Saratoga Springs, N.Y.-based contract research organization (CRO) Criterium has opened two offices in St. Petersburg, Russia, and Yavne, Israel. Criterium made its announcement recently at the 43rd Drug Information Association (DIA) annual meeting in Atlanta, Georgia. Criterium’s trial management model,
which employs technology flexibility and a centralized workflow process, makes its expansion into various emerging markets in clinical research possible.

Medidata Solutions and SAS Partner to Integrate eClinical Data

New York, N.Y.-based eClinical firm Medidata Solutions signed a major integration partnership with Cary, N.C.-based analytical software provider SAS. The two companies have completed - phase I of - a project to integrate Medidata’s clinical data management platform Rave, with SAS’ Drug Development (SAS DD), the company’s biopharmaceutical metadata analysis software.

Other breaking news...      

• Vedic in partnership with Amarex...
• DSG signs China partnership...

Company Profile: An interview with Daniel Spasic, chief executive officer, TFS Trial Form Support International

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

Premier Research Group Acquires Two More CROs

By Steve Zisson

London-based contract research organization (CRO) Premier Research Group continued its acquisition spree by purchasing two more CROs. Premier Research bought ARS Inc., based in Boston, and D-TARGET SA, located in Switzerland. Premier has acquired six CROs since 2004 when it went public.

Premier expects ARS will strengthen its presence in the New England biotech market while D-Target's medical device focus will bring expanded expertise in that area to customers in both the United States and Europe. ARS also has expertise in Oracle Clinical.

The acquisition of the two companies continues the Premier’s strategy of building an international business both organically and through strategic acquisitions.

Dr. Simon Yaxley, chief executive officer of Premier Research, said, "Both firms clearly represent a further important step in our strategy of building a leading international contract research organization."

Yaxley added that both companies have strong order books. "Both also offer a number of complementary synergies to the enlarged Group and further strengthen Premier Research's position in the international CRO market," he said.

-Read more on the acquisition in next week's CWWeekly.

Steve Zisson is managing editor at Thomson CenterWatch.

Clinquest Group Acquires Stake in Enceladus Pharmaceuticals

Amsterdam-based CRO Clinquest Group has acquired a stake in Enceladus Pharmaceuticals, the Netherlands-based developer of the inflammatory disorder treatment Nanocort—the product is in phase II trials. Clinquest also gathered a group of additional investment groups to back Enceladus as it brings more products to market.

“The participation of Clinquest in our activities allows us to complete the phase IIa clinical proof-of-concept trial with Nanocort that is currently ongoing in The Netherlands. Therefore this means a major boost to our clinical development track,” said Bart Metselaar, founder and chief executive officer of Enceladus.

Clinquest said it believed in Enceladus’ development pipeline and in the future of Nanocort.

“By entering in this risk-sharing arrangement, we are able to support the further development of Nanocort and the entire liposomal development platform most efficiently,” said Cees Wortel, chief executive officer of Clinquest Group.

Top Stories for the Week of July 2nd 2007

Top News

Parexel Expands Global Reach with New Hub in India

Waltham, Mass.-based contract research organization (CRO) Parexel International has opened a major clinical operations and data management office in Hyderabad, India.

ICON Taps Outcomes Firm Ovation for New Lifecycle Sciences Business Group

Dublin-based ICON Clinical has launched a new business unit called its lifecycle sciences group, focusing on outcomes research and economic analysis services.

Other breaking news...      

• AAHRP accredits 16 organizations...
• PharmaNet moves subsidiary Anapharm, to Quebec City...

Company Profile: An interview with Andrew Giddy, chief executive officer, Nucleus Network

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

Genzyme Reports Negative Results with hylastan for Pain

By Tracy Trundle

Genzyme reported negative results from a pivotal trial of hylastan for the treatment of pain associated with osteoarthritis of the knee. This double-blind, active-control study enrolled 400 subjects in North America and Europe. Subjects were randomized to receive two intra-articular injections of hylastan delivered two weeks apart, a single injection of hylastan, or an injection of a corticosteroid. They were then evaluated for 26 weeks. Each of the three treatment arms showed a statistically significant reduction in knee pain from baseline.

However, significance was not reached between the hylastan arm and the corticosteroid arm. Thus, the primary endpoint of demonstrating that hylastan provides superior pain relief than steroids was not achieved. Based on the results, Genzyme plans to fully analyze the data in order to determine a future course of action.

The company has another avenue toward reaching its goal of a single injection viscosupplementation -- product. Genzyme is currently seeking to market Synvisc-One, a combined-dose regimen of hylan G-F 20 provided in a single injection, in the United States and Europe.

“It is now clear that we will focus our efforts on bringing Synvisc-One to the market. We are confident that simplifying the treatment process will encourage a greater number of physicians and patients to seek the benefits of viscosupplementation to help manage OA knee pain. We will continue to analyze the findings from the hylastan study to determine how this product fits into our longer-range strategy, as we continue to invest in bringing innovation to this field,” said Ann Merrifield, president of Genzyme Biosurgery.

Tracy Trundle is a Research Analyst at Thomson CenterWatch.

Dr. Diana L. Anderson

Dr. Diana L. Anderson is the president, CEO and founder of D. L. Anderson International, Inc., parent company to subsidiary D. Anderson & Company.  She is an early and tireless advocate for professionalizing the patient recruitment and enrollment processes, and has published numerous articles on this subject, stressing the critical importance of early strategic planning, keeping metrics, developing partnerships and improving retention. 

Over the past several years, Dr. Anderson’s expertise in patient recruitment has attracted an international following.  She has become a much sought-after speaker across the globe, addressing audiences in countries such as Israel, Australia, Japan and England.

The depth of her patient recruitment experience is captured in her latest text, International Patient Recruitment Regulatory Guidelines, Customs and Practices. She authored earlier books A Guide to Patient Recruitment and Retention (2004), A Guide to Patient Recruitment (2001) as well as a publication for the lay audience entitled 50 Ways to Cope with Arthritis.   

Dr. Anderson is also past-chairman of the Board of ACRP.  She is currently chair of The Academy of Clinical Research Professionals, a division of ACRP.

Criterium Opens Offices in Russia, Israel

By Sara Gambrill

Saratoga Springs, N.Y.-based contract research organization (CRO) Criterium has opened two new offices in St. Petersburg, Russia, and Yavne, Israel. Criterium made its announcement recently at the 43rd Drug Information Asociation (DIA) annual meeting in Atlanta, Georgia.

Criterium, founded in 1991,  has 91 employees. It has offices in New York, California, Florida, India, South Africa, The Netherlands, Russia and Israel. The company began conducting clinical trials in Asia, South America and Europe in 1997.

Its newest office in Russia has three full-time employees and the office in Israel has one, Ayelet Bar-Dov, clinical liaison/business development associate. Prior to joining Criterium, Ms. Bar-Dov worked as regional sales representative at Teva Pharmaceutical Industries.

Criterium’s trial management model, which employs technology flexibility and a centralized workflow process, makes its expansion into various emerging markets in clinical research possible.

“We’re tying it all together with our technology and our workflow. We fit the technology to the region. Technology is a tool, but workflow makes it work. Our hub is in New York. All data comes into it and goes back out to sites, then we manage the monitors using real data that comes in,” John Hudak, president and founder of Criterium, told CWWeekly at DIA.

Hudak’s first considerations when establishing a new office are the regulatory process, patient population and quality sites. Criterium has plans for further growth that include the Pacific Rim and South America.

“We have plans [to open offices in] New Zealand and South America. The regulatory process has to be reasonable. We’ve done work in Chile and just finished work in Ecuador,” said Hudak. “In today’s global studies, it is more important than ever to adopt an agile approach, which means finding the appropriate patients and combining various data collection tools with a standardized, centralized workflow, which allows timelines to stay on track and costs to be kept in line.”

Sara Gambrill, Senior Editor at Thomson CenterWatch and author of The Emerging Markets of Clinical Research.