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CWWeekly April 28th 2008 Issue

May 2, 2008 3:44:06 PM

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Top News

PeerView Acquires Veritas’ Clinical Trial Disclosure Business

Newtown, Pa.-based PeerView, a provider of medical journal publishing technology, acquired the clinical results disclosure platform from Cambridge, Mass.-based Veritas Medicine. The platform, called Veritas Clinical Trial Register (VCTR—or ‘victor’) was one of the last remaining pieces of Veritas’ business offerings after it discontinued its patient recruitment services and laid off a number of employees in February 2008.

Novotech Expanding in Asia-Pac, U.S.

Having opened offices in both Hydera-bad, India, and Seoul, Korea, recently, Novotech shared its plans for an ambitious expansion throughout the Asia-Pacific region. The Korean office has three employees, and India has a slightly different model with a manager and 26 monitors that Novotech has arranged to have through a partner and is therefore able to cover the entire country. Novotech’s plans do not stop with Asia-Pac. The company is also looking at opportunities for creating a bigger presence in North America to get closer to its clients there.

Other breaking news...      

Company Profile: An interview with Dan Ulrey, president and chief executive officer, Midwest Clinical Support, Inc.

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.

CWWeekly April 21st 2008 Issue

Apr 25, 2008 1:52:00 PM

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Top News
      
SpineMark CRO Creates Own Multi-Site Research Network

SpineMark CRO Management
, a contract research organization (CRO) is creating a multi-site network of dedicated research centers, collaborating first with clinical investigators in Los Angeles and Denver. SpineMark CRO plans to have 20 such sites in place by the first quarter of 2009. Eventually, the company wants to have 35 centers across the U.S. and 10 outside the country.

AbCRO Opens Office in Ukraine

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened an office in Kiev, Ukraine. The opening comes just on the heels of the company’s two new offices in Russia—one in St. Petersburg and one in Moscow. The opening comes just on the heels of the company’s two new offices in Russia—one in St. Petersburg and one in Moscow.
    
Other breaking news...      

Company Profile: An interview with James McDermott, corporate development director, Quanticate

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.

 

CWWeekly April 14th 2008 Issue

Apr 19, 2008 12:07:00 PM

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Top News
      
Coast IRB Receives FDA Warning Letter

Coast IRB, an independent institutional review board (IRB) based in Colorado Springs, Colo., received a Warning Letter from the U.S. Food and Drug Administra-tion (FDA) concerning the company’s improper expedited review of a phase I study being conducted in northern California. In an unusual move, the agency has temporarily suspended the IRB’s ability to do expedited reviews.

LabConnect Gains Centralized Pathology Testing with Bostwick Scientific Deal

LabConnect, a clinical trial–focused central laboratory provider based in Seattle, Wash., has inked an agreement with Bostwick Laboratories, adding one of the top anatomic pathology testing companies to its international list of networked labs.
      
Other breaking news...      

Company Profile: An interview with Paul Bishop, managing partner, and Lyle Camblos, managing partner, Atlantic Research Group

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.


 

CWWeekly April 7th 2008 Issue

Apr 11, 2008 5:12:44 PM

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Top News

Parexel Buys Larger Stake in India Venture and Expands Phase I Business in U.S., Europe

Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.

Progenitor Grows Organically in Latin America, India

The opening of 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.

Other breaking news...

Averion’s 2007 net service revenue up...
Baylor College publishes plan for improving clinical trials...

Company Profile: An interview with Janice Sidorick, MPH, managing director, Janix, 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.

CWWeekly March 31st 2008 Issue

Apr 4, 2008 12:01:29 PM

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Top News     

Bio-Imaging Technologies Acquires Phoenix Data Systems

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.      

inVentiv Clinical Moves into Latin America

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 São Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

Other breaking news...      

Quintiles inks agreement with Medca Japan...
Encorium Group inks $2.5 million in new contracts...

Company Profile: An interview with Patrick Hughes, senior vice president, Exco InTouch

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.

CWWeekly March 24th 2008 Issue

Mar 28, 2008 11:04:00 AM

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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...      

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.

CWWeekly March 17th 2008 Issue

Mar 21, 2008 11:18:34 AM

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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.

CWWeekly March 10th 2008 Issue

Mar 14, 2008 10:30:00 AM

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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.

CWWeekly March 3rd 2008 Issue

Mar 7, 2008 11:10:12 AM

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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... 

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.

CWWeekly January 25th 2008 Issue

Mar 3, 2008 10:05:00 AM

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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

CWWeekly February 18th 2008 Issue

Feb 22, 2008 11:47:39 AM

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Top News

ICON Acquires Phase I Unit in Texas

Dublin, Ireland-based ICON made its move into the U.S. phase I market with its acquisition of Healthcare Discoveries, a San Antonio, Texas-based 40,000-square-foot, 85-bed clinical pharmacology unit. The company, owned by Catalyst Pharma Group, was purchased by ICON for $12 million in cash and performance payments of up to $10 million to be paid by the end of 2008. The buy will more than double ICON’s total phase I capability and expand its services across the Atlantic. ICON already operates an 80-bed, full-service pharmacology unit in Manchester, England.

Chiltern Buys Second Phase I Unit in UK

London-based contract research organization (CRO) Chiltern acquired Drug Development Solutions (DDS), a phase I facility based in Dundee, Scotland. The 45-bed unit is located at the Hospital and Medical School. Including the company’s facility in Slough, Chiltern now has a total of 72 beds in its phase I division.

Other breaking news...      

Company Profile: An interview with Vijai Kumar, M.D., president and chief medical officer, Excel Life Sciences

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.

CWWeekly February 11th 2008 Issue

Feb 15, 2008 12:32:26 PM

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Top News

Veritas Medicine Restructures Business and Drops Trial Listing Service

Cambridge, Mass.-based Veritas Medicine, a clinical trial services company, has discontinued its patient recruitment services and laid off a number of employees. According to Veritas, it is restructuring the company to focus solely on its clinical trial disclosure business. The company’s clinical trial listing service and patient screening business will be terminated. Veritas stated it ceased providing patient recruitment services on Feb. 8.

PPD Buys Russian CRO InnoPharm

Wilmington, N.C.-based PPD acquired contract research organization (CRO) InnoPharm, based in Smolensk, Russia. InnoPharm has a staff of 300 and has additional offices in Moscow, St. Petersburg and Kiev, Ukraine. It offers late-stage services in clinical monitoring, data management and biostatistics. No financial details of the transaction were given.

Other breaking news...      

  • Covance reports jump in fourth quarter revenue...
  • Medidata wins a contract with Eliassen Group...

Company Profile: An interview with William Cooney, president and chief executive officer, MedPoint Communications

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.

CWWeekly Feb. 4th 2008 Issue

Feb 8, 2008 2:22:27 PM

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Top News

Synarc Adds Hong Kong to List of Global Research Centers

San Francisco, Calif.-based contract research organization (CRO) Synarc launched a dedicated clinical research center in Hong Kong’s central district. The unit is more than 3,000 square-feet and operated by a dozen local staff members. A typical Synarc clinic is about 20,000 to 30,000 square-feet. Synarc conducts all its clinical trials at either its own sites or at sites run by partners. The company now owns 11 sites in Denmark, Estonia, Lithuania, Brazil, Romania, Poland, Czech Republic and mainland China.

PPD Breaks into China Central Lab Business

Wilmington, N.C.-based contract research organization (CRO) PPD made its first foray into the rapidly growing Chinese central laboratory market with the launch of its own unit, in cooperation with Peking Union Lawke Biomedical Development Limited (PUL). The exclusive agreement allows PPD to establish a commercial entity located on a separate campus near Peking Union Medical College Hospital (PUMCH). The facility is headed by Mayo Clinic–educated Jian Ho, M.D, Ph.D. The PUL has 60 highly trained local personnel.

Other breaking news...

Clinical Data signs agreement with Affymetrix...
Phase Forward reports strong growth...

Company Profile: An interview with Ibrahim Farr, MD, PhD, chief executive officer, Pivotal

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.

CWWeekly January 28th 2008 Issue

Feb 1, 2008 11:09:45 AM

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Top News   

MDS Pharma Opens Large Phase I Unit in Arizona

King of Prussia, Pa.-based contract research organization (CRO) MDS Pharma Services launched a 300-bed phase I facility just outside Phoenix in Tempe, Arizona. The unit cost about $25 million and took more than two years to complete. According to MDS, the new unit is the largest phase I clinic on the West Coast. By building the unit specifically for phase I services, MDS stated it was able to include specialized features such as thorough QT cardiac safety trial areas and improved security for conducting controlled trials. The facility also has its own clinical lab and pharmacy.

ICON Expands in Eastern Europe

Contract research organization (CRO) ICON Clinical Research expanded its presence in Central and Eastern Europe with the addition of three offices located in Prague, Czech Republic; Kiev, Ukraine; and Bucharest, Romania. Each office will be staffed with 60 to 75 employees. In the region, the CRO already has offices in Russia, Latvia, Lithuania, Poland and Hungary. According to Alan Morgan, president of ICON Clinical Research Europe, clients drive office expansion into these areas.

Other breaking news...

Pharm-Olam reports record revenue growth in 2007...
LabCorp to acquire Tandem Labs...

Company Profile: An interview with Bruce Hillman, M.D., director of scientific affairs, and Michael Morales, general manager, ACR Image Metrix

CWWeekly January 22nd 2008 Issue

Jan 25, 2008 3:31:52 PM

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Top News
      
U.S. Supreme Court Will Not Hear Abigail Alliance v. Eschenbach

The Abigail Alliance’s petition for a writ of certiorari in The Supreme Court of the United States was denied on January 14. The question presented was “whether terminally ill patients who lack alternative treatment options have a constitutional right to purchase unapproved investigational drugs that have not been shown to be safe or effective and that have not been authorized for treatment uses by the Food and Drug Administration.”

Cetero Research Adds Metabolic Expertise with DGD Acquisition

Cary, N.C.-based early stage contract research organization (CRO) Cetero Research broadened its range of therapeutic area research with the acquisition of San Antonio, Texas-based CRO, DGD Research. Financial details were not disclosed. The acquired CRO, which conducts studies in both early- and late-stage trials, was formerly known as Diabetes & Glandular Disease Research Associates.

Other breaking news... 

Company Profile: An interview with Michael O’Connell, director of Life Science Solutions Group, Insightful, Life Sciences Division

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.

 

CWWeekly January 14th Issue 2008

Jan 18, 2008 5:01:19 PM

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Top News

Inclinix Gets $10 Million Infusion from Frontier Capital

Wilmington, N.C.-based patient enrollment contract research organization (CRO) Inclinix has raised $10 million in venture capital from private equity firm Frontier Capital. Being a patient recruitment CRO driven by metrics and analytical services, Inclinix needed funds to help develop their technologies. As an ex-venture capitalist himself and having had interactions with Frontier Capital in the past, Inclinix’s president and chief executive officer, Tobin Geatz, knew just where to turn.

ResearchPoint Gains an Imaging Partner with M2S Addition

Austin, Texas-based contract research organization (CRO) ResearchPoint Global has added a core imaging lab to its joint-venture partnership network with the addition of M2S, a medical data and imaging systems company based in West Lebanon, N.H. M2S offers clients the ability to manage their imaging data on secure imaging servers that are accessible through web-based platforms.

Other breaking news...

Company Profile: An interview with Luke Eley, European Business Development Director, Hays Pharma

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.

CWWeekly January 7th 2008 Issue

Jan 11, 2008 10:28:09 AM

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Top News

PPD Completes New Leadership Appointments in Global Move

Wilmington, N.C.-based contract research organization (CRO) PPD continues revamping its global operations with the appointment of Sebastian Pacios, M.D., hired to lead as a senior vice president, the CRO's European, Middle East and Africa operations. Last year, PPD set out to break its phase II-IV operations into four separate territories: North America; Latin America; Europe, Middle East and Africa; and Asia. PPD has been steadily appointing new leaders to these regions since then. PPD’s move is more evidence of the emphasis CROs are now putting on global expansion, as more sponsors push for overseas trials. 2007 saw significant CRO expansions into emerging markets as companies worked hard to keep up with pharma and biotech.

Medpace Enters Early Stage Business

Cincinnati-based contract research organization (CRO) Medpace launched a 50-bed phase I/IIa unit, beginning the company's first foray into the early stage clinical trial outsourcing business. The group—called the Medpace Clinical Pharmacology Unit—will be the company’s third subsidiary following Imagepace, a core imaging laboratory, and its central lab, Medpace Reference Laboratories.

Other breaking news...
      

Company Profile: An interview with Elise Huszar, MBA, president, The Geneva Foundation

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.

CWWeekly December 10th 2007 Issue

Dec 14, 2007 9:51:09 AM

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Top News

Global Clinical Trials Opens Office in Romania

Princeton, N.J.-based Global Clinical Trials (GCT), a contract research organization (CRO) with operations in Central and Eastern Europe, has opened a regional office in Bucharest, Romania.

PRA Winds Down Busy Year with Phase I Acquisition

Raleigh, N.C.-based contract research organization (CRO) PRA International will be ending a year of transformation with an early management shakeup, an equity buyout, a relocation of its headquarters out of state, and finally an acquisition in the European phase I market.

Other breaking news...      

Company Profile: An interview with John Farinacci, chief executive officer, ResearchPoint

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.


CWWeekly December 3rd 2007 Issue

Dec 7, 2007 3:10:00 PM

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Top News

MJFF Signals Increasing Investment in Clinical Research

The Michael J. Fox Foundation for Parkinson's Research (MJFF) has appointed Irene Hegeman Richard, M.D., to the newly created position of senior medical advisor, a sign that MJFF's investment in clinical research will continue to increase.

eResearch Technology Buys Covance's ECG Unit

In a deal potentially worth $50 million, eResearchTechnology (eRT), a Philadelphia-based eClinical company made a major purchase with the acquisition of the cardiac safety business unit of Princeton, N.J.-based contract research organization (CRO) Covance.

Other breaking news...

Company Profile: An interview with Toru Mimura, Ph.D., president and chief executive officer,IBERICA USA, Inc.

CWWeekly November 26th 2007 Issue

Nov 30, 2007 10:22:21 AM

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Top News

Nevada Doctor Reports Cherie Thibodeau to Attorney General's Office

Cherie Thibodeau, a fraudulent study broker, may not be working her scam much longer. For the past few months, she has been trying to solicit Las Vegas area doctors for business, using a business card that says, “Cherie Thibodeau, M.D., PhD., Chief Medical Officer/Clinical Operations.” As far as can be determined, Cherie Thibodeau does not have a license to practice medicine, and posing as someone with a medical license is an offense that is under the jurisdiction of the Attorney General’s Office in Nevada. One Nevada doctor, whose confidence Thibodeau gained, reported her to the Attorney General’s office last week.

Three Clinical Trial Companies Form Cardiac Safety Network

iCardiac Technologies, Spacelabs Healthcare and Charles River Laboratories, three companies helping sponsors determine the effects of new drugs on the heart, have joined together to form a collaborative called The Cardiac Safety Network. The network combines each vendor’s core competencies dealing with clinical cardiac safety trials to offer sponsor clients a single point of contact for recruiting healthy volunteers, running studies and analyzing cardiac testing data.

Other breaking news...      

Company Profile: An interview with Russell Rosenberg, Ph.D., president, NeuroTrials 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.

CWWeekly November 19th Issue

Nov 23, 2007 6:00:00 AM

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Top News 

etrials Aims for Profitability with Rebuilding Plan

etrials' third quarter revenue fell and its loss widened amid deep restructuring and organizational changes planned for the next two to three quarters. The company is trying to climb its way to profitability and improve its service delivery issues.

Quintiles Makes First Buy in Central America with Bio-Trials

Research Triangle Park, N.C.-based contract research organization (CRO) Quintiles made its first Central American acquisition with the purchase of Panama-based CRO Bio-Trials. Terms of the sale were not disclosed.

Other breaking news...      

Company Profile: An interview with Gail Adinamis, president and chief executive officer, Clinical Resource Network

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.  

CWWeekly November 12th Issue

Nov 16, 2007 3:16:00 PM

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Top News

Ergomed Opens Office in Dubai

Frankfurt, Germany-based contract research organization (CRO) Ergomed Group has opened a new regional headquarters in Dubai City's new life sciences research park, DuBiotech. The company plans to use the office as a hub for its operations in the Middle East and India. The company’s main headquarters is located in the Frankfurt Biotechnology Innovation Center, which has collaborated with DuBiotech since 2005. The center brought the CRO and DuBiotech together to discuss the opportunities in Dubai and an agreement was made just a few months later. The 20 million square-foot space, or nearly one square-mile, was set aside by the Dubai government for the research park to attract international research and development companies to do business in the Dubai emirate, a state within the United Arab Emirates.

Averion Buys Hesperion

Southborough, Mass.-based contract research organization (CRO) Averion International acquired Swiss-based CRO Hesperion AG from its French parent company Cerep SA. Averion will pay $36.2 million forvthe company. To finance the acquisition, Averion issued three-year senior secure notes on the company’s current debt. The debt financing raised $24 million towards the purchase. Phillip Lavin, Ph.D., resigned as chief executive officer of Averion on Oct. 31, and was immediately appointed as executive chairman of the company. He was replaced by Hesperion’s chief executive officer Dr. Markus Weissbach, who was appointed head of Hesperion in September 2006.

Other breaking news...

  • ICON reports strong third quarter revenues...
  • AAIPharma opens office in Hungary...

Company Profile: An interview with Kristine Kuryla, operations manager, University of Rochester Medical Center Clinical Trial Central Laboratory

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.  

Top Stories for the Week of Nov. 5th 2007

Nov 9, 2007 5:00:14 PM

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Top News

Chiltern Builds on U.S. Presence with Acquisition of Clinical Trial Management Services

Known for its European presence, UK-based contract research organization (CRO) Chiltern International decided to boost its U.S. business with its acquisition of Clinical Trial Management Services (CTMS), a Tennessee-based CRO. This is the first acquisition for Chiltern since the CRO was purchased in July by Czura Thornton, a private investment group led by Antony Czura and Nick Thornton.

Phase Forward Buys Phase I Software Company Green Mountain Logic

Waltham, Mass.-based eClinical provider Phase Forward purchased Green Mountain Logic (GML), a Montpelier, Vt.-based software company and maker of phase I software product, LabPas. The software allows for electronic management of sample processing, reporting of clinical results and real-time data capture of patient vital signs.

Other breaking news...

Company Profile: An interview with Eric Lawitz, medical director and principal investigator, Alamo Medical Research

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!

Top Stories for the Week of Oct. 29th 2007

Nov 2, 2007 3:08:00 PM

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Top News

NEJM Takes Shots at CROs

A recent New England Journal of Medicine (NEJM) Perspective piece criticized the clinical trials industry for its reliance on contract research organizations (CROs). The piece describes the rapid growth in the CRO industry, questions the quality of research data it generates and cites various clinical trials that have shed some negative light on CRO-run studies.

PPD Continues Geographic Expansion While Reporting Strong Third Quarter

While reporting a 14% increase in its third quarter revenue, Wilmington, N.C.-based contract research organization (CRO) PPD opened new offices on four continents.The company launched offices in Sydney, Australia; Copenhagen, Denmark; Lima, Peru and Lisbon, Portugal. PPD has also expanded its presence in India with new office space.
    
Other breaking news...     

Company Profile: An interview with Ginger Clasby, vice president business development, Promedica 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!

Top Stories for the Week of Oct. 22nd 2007

Oct 26, 2007 12:01:28 PM

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Top News
 
Omnicare Clinical Research Expands in India

In an effort to gear up for the company's growth in India, King of Prussia, Pa.-based contract research organization (CRO) Omnicare Clinical Research has doubled the size of its Bangalore, India, office by relocating to a 10,000-square-foot facility nearby. Omnicare Clinical Research established its first presence in India in 2002 with the opening of its original Bangalore location. The CRO’s new location will act as the company’s central hub for all operations in India. It will add staff for clinical monitoring, data management, business development and administrative. The location already has a staff of 75.

Medicare's Trial Coverage Memorandum Calls for Further Study

The Center for Medicare and Medicaid Services (CMS) will seek further comment on proposals for covering the costs of clinical trials for Medicare beneficiaries. In July 2006, the Center for Medicare and Medicaid Services (CMS) began a process of shoring up several six-year-old policy issues dealing with insuring beneficiaries participating in clinical trials. On July 9 of this year, CMS issued a draft proposal and invited public comment. But after a long summer of negotiations with stakeholders, CMS issued it Final Decision Memorandum stating it could not make new policy changes to the draft proposal.

Other breaking news...

Company Profile: An interview with Igor Stefanov, director of business development, Synergy Research Group

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!

Recent Industry Personnel News

Oct 24, 2007 1:55:31 PM

Contract Research

San Diego-based SpineMark, a network of spine centers, has appointed Alan Donald, M.S., M.B.A to the president of SpineMark CRO Management. The company also appointed Alan Iftiniuk as its interim chief operating officer. Donald has 25 years of experience working in drug, medical device and diagnostic companies. In 1999, Iftiniuk was president and chief executive officer of Good Shepherd Hospital in Barrington Ill., now a SpineMark Center. Prior to SpineMark, he worked at growing both commercial and non-profit hospital-based entities.

Cincinnati-based CRO Kendle promoted Ken Hintze, Ph.D, to the position of vice president of global clinical safety and pharmacovigilance. Recently, Hintze was senior director for the department. He joined Kendle in 2002 after a 23 year career at Proctor & Gamble where he held various roles involving product safety.

Pennsylvania-based CRO Omnicare Clinical Research promoted Nancy Meyerson-Hess to the role of senior vice president of international project management. Meyerson-Hess previously served as vice president of the group. Prior Omnicare Clinical Research, she held the position of director of project management for Central Europe at PRA International.

Philadelphia-based Premier Research Group named W. Scott Keenen to the position of vice president of global human resources. Just prior to Premier Research, Keenen was global director human resources for inCode Telecom. Premier also appointed Melissa Jones to the position of vice president of international business development. Jones previously held positions at Kendle, Quintiles, MDS Pharma Services and Innovex.

Dublin-based CRO ICON hired Dr. David Shaw to the newly created position of senior director of ICON Development Services’ EU Regulatory Affairs department. Prior to ICON, Shaw was the founder and director of PharmDev Consulting Services. He also held senior roles at Johnson & Johnson as director of global pre-clinical development and at Elan as director of development and regulatory affairs.

Massachusetts-based imaging CRO WorldCare Clinical hired Carol Adiletto to the position of senior vice president of clinical operations and regulatory affairs. Prior to WorldCare, she held positions at Pluromed and Inverness Medical Innovations.

Sponsors

Cellectar, a radiopharmaceuticals company, appointed Ernest Allen to director of clinical operations and
LisaAnn Trembath to manager of medical affairs. Prior to Cellectar, Allen held senior posts at UK-based CRO Origin Pharmaceuticals, Parke-Davis, Amgen and Alcon. Most recently he was clinical manager for
Tapestry Pharmaceuticals. Trembath has 21 years in the medical imaging, including 10 years in clinical research. Prior to Cellectar, Trembath was senior clinical affairs specialist in the medical affairs division of Bristol-Myers Squibb Medical imaging.

Technology

New York-based eClinical Company Medidata Solutions appointed key personnel to the company’s safety and quality assurance department. The appointments include Barton Cobert, M.D., to vice president of global regulatory initiatives and pharmacovigilance,  Frances Nolan to vice president of global quality assurance and Tony Hewer, senior director of global quality assurance for EMEA. Colbert previously served as global head of drug safety and pharmacovigilance at Novartis’ consumer health division. Nolan
held numerous positions in IT at Taratec Development, Pfizer and Oracle. Brewer worked in various senior IT positions at Pfizer, Braxxon Technology and Data Logic.

Top Stories for the Week of Oct. 15th 2007

Oct 19, 2007 11:21:13 AM

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Top News

INC Plans to Double Size by Adding 1,100 Staff at Raleigh Headquarters

Raleigh, N.C.-based INC Research, a contract research organization (CRO), was awarded $14.8 million by the Economic Investment Committee of North Carolina’s Department of Commerce to make a big commitment to expand operations in the state. INC has promised to add 1,093 new jobs and local investments of $19.2 million over the next four years.

Interspond Develops Automatic Patient Reimbursement System

Interspond, a trial management organization (TMO) based in Madison, Wis., has launched what it claims is the first electronic patient reimbursement (EPR) tool. The tool, RxPaying, uses an ATM debit card system to pay subjects directly after each visit. The system is completing its final phase of testing and should be up and running by mid-November.

Other Breaking News...

Company Profile: An interview with Cami Gearhart, chief executive officer, Quorum Review


Top Stories for the Week of Oct. 8th 2007

Oct 12, 2007 11:29:00 AM

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Parexel Acquires Taiwan-based CRO APEX Clinical Research

Waltham, Mass.-based contract research organization (CRO) Parexel International purchased APEX Clinical Research, a CRO based in Taiwan with operations throughout the Asia-Pacific region. The company paid $50.9 million in cash for the remaining 20.3 million shares of APEX. The newly acquired company will become a wholly owned subsidiary and will be called Parexel APEX International. Parexel had already purchased a minority interest in the CRO in April 2003.

DSG Takes on EDC, Randomization and Supply Integration

DSG has replaced the need to use an interactive voice response system (IVRS) for complex randomization to obtain drug kit numbers, thus cutting out a third technology vendor. By using eSourcing on a tablet PC and DSG’s eCaseLink EDC system, site investigators were able to record patient information in real time and receive randomized and blinded kit numbers for drugs already shipped from the sponsor. This also eliminated the need to reconcile the IVRS data with a site’s main trial management system.

Other breaking news...      

Company Profile: An interview with Kathleen Ashenfelter, director, operations and development, Cu-Tech

Top Stories for the Week of Oct. 1st 2007

Oct 5, 2007 6:28:00 AM

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Top News

HHS Report Rips FDA's Human Subject Protection Efforts and Lack of Site Audits

The U.S. Food and Drug Administration (FDA) audited fewer than 1% of investigative sites, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, found in a report released Friday. The 41-page report said the FDA has just 200 specially-trained inspectors to audit an estimated 350,000 investigative sites. Others estimate that the number of sites is much lower. The report found that federal health officials did not even know how many clinical trials were being conducted in the U.S. According to CenterWatch, an estimated 59,000 drug trials, phases I, II and III, were being conducted worldwide in 2006.

PDUFA Revitalization Act to Boost Post-Approval Sector

Congress' recent reauthorization of the U.S. Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA) included a series of changes that will no doubt have profound effects on the clinical trials industry. Enacted in 1992, PDUFA needs to be renewed every five years. It was set to expire on Sept. 30. It allows the FDA to collect fees from drug and device companies applying for regulatory approval. The new bill calls for an increase in those submission fees to bolster FDA’s drug safety review and post-approval monitoring initiatives, much of which were created after a series of high profile recalls and safety issues. Under the bill, pharmaceutical developers would pay nearly $400 million and medical device makers $48 million in fees next year, a 25% increase.

Other breaking news...      

Company Profile: An interview with Murray Jensen, director of clinical and scientific affairs; Martin Letendre, director of ethics and legal affairs; Ramesh Chouhan, president (technical), Matrix Group;ethica Clinical Research, ethicamatrix.

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!


Top Stories for the Week of Sept. 24th 2007

Sep 28, 2007 11:55:16 AM

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Top News

Economic Modeling Company Caro Research Acquired by UBC

Maryland-based contract research organization (CRO) United BioSource Corporation (UBC) continued its acquisition flurry by purchasing Caro Research, a cost modeling and economic simulations provider based in Concord, Mass.

Accenture and Bristol-Myers Squibb Create Joint Pharmacovigilance Center in India

New York-based Accenture, a global consulting and outsourcing firm, and pharmaceutical company Bristol-Myers Squibb (BMS) have established a pharmacovigilance center in Chennai, India the first of its kind to monitor the pharmaceutical company's safety data. Accenture will contribute more than 140 employees to the center.

Other breaking news... 

Company Profile: An interview with and Mary-Ann Richardson, chief executive officer of African Clinical Research Organisation, and Christopher Whitfield, chief executive officer of Batswadi Pharmaceuticals, African Clinical Research Organisation.

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!

Top Stories for the Week of Sept. 17th 2007

Sep 21, 2007 7:53:00 AM

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Top News

UBC Buys Stake in ClinResearch

Maryland-based contract research organization (CRO) United BioSource Corporation (UBC) bought an ownership stake in ClinResearch, a Germany-based CRO with a strong focus on adaptive clinical trials. No financial details were given.

AstraZeneca Builds Phase I Unit with Peking University

AstraZeneca has launched its first phase I facility in China through a partnership with Peking University Third Hospital.

Other breaking news...      

Company Profile: An interview with Kenneth Kim, founder and chief executive officer, and Yves Grenon, vice president of business development, West Coast Clinical Trials

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!

Top Stories for the Week of Sept. 10th 2007

Sep 14, 2007 8:19:00 AM

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Quintiles Launches Patient Website iGuard for Drug Safety Service

In an unusual move for a contract research organization (CRO), Research Triangle Park, N.C.,-based Quintiles has created a new service specifically for consumers of prescription drugs. The free service is called iGuard, a drug risk monitoring and personalized safety alert online site, and it’s a significant step toward patient-directed research.

ethica Creates Indian CRO Through Joint Venture

Montreal-based contract research organization (CRO) ethica Clinical Research has created a joint venture with Matrix Group, a healthcare company based in Hyderabad India. The new Indian CRO is called ethicamatrix. The model is similar to other recent partnerships, joint ventures and mergers between Western CROs and local entities in emerging markets such as India, China and countries in Eastern Europe. The strategy works because it leverages the existing local infrastructure with standardized, quality clinical trial management experience.

Other breaking news...      

Company Profile: An interview with Cristy Anderson, president, Clinical Research Advantage

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!


Top Stories for the Week of Sept. 4th 2007

Sep 7, 2007 11:07:35 AM

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Top News

Medpace Expands in Eastern Europe with Acquisition

Cincinnati-based contract research organization (CRO) Medpace made its first acquisition with the purchase of Monax, a CRO based in Prague, that it has worked with previously. The deal was a classic partnership turned purchase for the CRO. But the acquisition was a departure from Medpace’s stated organic growth-only philosophy. However, according to Dr. August Troendle, chief executive officer at Medpace, it was a cementing of a working partnership rather than a merger. 

Promedica Forms Alliance with Russian CRO Synergy Research Group

Less than a year ago, Costa Mesa, Calf.-based contract research organization (CRO) Promedica International set out to find a suitable Russian CRO to form an alliance that would expand its geographical reach. Its plan was to tap into the emerging Russian clinical trials market by working with a local company already familiar with the country's clinical research environment. Just about the same time, Moscow-based Synergy Research Group began looking for the same type of partnership: a U.S.-based CRO with a large pool of international clients and the capability of conducting large trials in the West.

Other breaking news...     

Company Profile: An interview with Charles H. Ballow, PharmD, director, Buffalo Clinical Research Center

Top Stories for the Week of August 27th 2007

Aug 31, 2007 7:52:00 AM

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Top News

First Locally Owned, Black-Empowered CRO Launches in South Africa

African Clinical Research Organisation (ACRO), the first locally owned, black-empowered full-service contract research organization (CRO) in Johannesburg, South Africa, launched this month.

Quorum Opens IRB Services in Canada with New Board

Sponsors who conduct multicenter clinical trials in the United States typically include some Canadian sites. These projects are often tied into a single North American program. Seeing this trend for many years, Seattle, Wash.-based independent review board (IRB) Quorum Review decided to create a new North American ethics review board capable of offering its clients services for Canadian trials.

Other breaking news...
      

Company Profile: An interview with Michael Spigarelli, medical director, Cincinnati Children's Research Foundation

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!

Top Stories for the Week of August 20th 2007

Aug 24, 2007 7:45:00 AM

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Top News

Qualia Acquires Early Stage Facility in Kiev

Taking note of sponsors looking to Eastern Europe for early stage services, Omaha, Neb.–based contract research organization (CRO) Qualia Clinical Services has acquired a 60–bed, 10,000–square–foot early stage clinical facility in Kiev. The unit was purchased from a small CRO in the Ukraine.

Homecare Trial Services Provider Clinical Resource Network Raises Capital

Working with an uncommon business model, Illinois–based Clinical Resource Network (CRN), a provider of homecare services for clinical trials, aims to tackle the industry's patient recruitment problems with a simple solution. It takes the trial to the patients. Now with an infusion of capital from WHI Capital Partners, a Chicago–based private equity firm, the company is gaining traction.
    
Other breaking news...      

  • Parexel's fourth quarter revenue jumps...
  • Datatrak's second quarter revenue slumps...

Company Profile: An interview with Jeff Williams, chief executive officer, Clinipace

Past weekly article summaries for the year can be found in the