- PAREXEL
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PAREXEL International 
Type Public (NASDAQ: PRXL) Industry Contract Research Organizations
PharmaceuticalFounded 1982 Headquarters Lowell, Massachusetts, United States of America;
70+ facilities in 50+ countriesKey people Co-Founder and CEO:
Josef H. von Rickenbach, Co-Founder and Senior Vice President Anne SayighProducts biopharmaceutical product development
regulatory consulting
clinical pharmacology
clinical trials management
medical education and reimbursement
advanced technology solutions, including EDC and medical imagingRevenue 
$1,050,755 thousands USD (2009)Employees ≈9,200 (2010) Website www.parexel.com PAREXEL International is a contract research organization (CRO), based in Lowell, Massachusetts and founded in 1982 by Josef H. von Rickenbach (still current CEO) and Anne Sayigh. It provides services for companies in the pharmaceutical, biotechnology and medical device industries, including consulting, clinical studies and market launch. The name PAREXEL comes from Paracelsus, a Swiss physician considered as the father of modern toxicology.[1] PAREXEL employs more than 9,000 people worldwide in over 50 countries[2] and has supported all of the top 20 leading biotechnology companies, all of the top 10 largest pharmaceutical companies[1] and nearly all of the 50 best-selling drugs on the market.[3]
The company provides services during all phases of the development of a drug, from planning to commercialization. It includes strategy development, clinical trials management, data management, biostatistical analysis, regulatory affairs, drug development consulting, medical marketing, training, publishing and advanced technology. PAREXEL won "CRO of the Year" in 2008 in The Scrip Awards.
Contents
Recent Acquisitions
In 2008, PAREXEL closed the acquisition of ClinPhone plc, combining the company with its wholly owned subsidiary Perceptive Informatics, to provide additional eClinical solutions to facilitate the clinical development process. The Perceptive Informatics expanded technology portfolio now includes Randomization and Trial Supply Management technologies, Electronic Data Capture, Medical Imaging, Clinical Trial Management Systems (CTMS), and Electronic Patient-Reported Outcomes (ePRO). Perceptive Informatics won the European Outsourcing Award in 2009 for the Best e-Business/IT Strategy from PharmaTimes.
During 2007, PAREXEL completed the acquisition of Taiwan-based APEX International Clinical Research Co., Ltd. APEX locations were combined with the company’s previous existing presence in Japan, India, and Australia to expand its clinical research services throughout the Asia/Pacific region, including in mainland China, Hong Kong, India, Taiwan, Singapore, Indonesia, South Korea, Malaysia, Thailand, the Philippines, New Zealand and Australia. PAREXEL has 1,600 employees in the Asia/Pacific region and 17 offices throughout 12 countries. Prior to the acquisition, in 2003 PAREXEL had purchased a minority interest in APEX, which had carried out numerous clinical studies with PAREXEL. PAREXEL received the BioSingapore Award for Best Performing CRO in 2009 from BioSingapore, an industry association for life sciences businesses encouraged by the Economic Development Board of Singapore.
In 2006, PAREXEL completed the acquisition of California Clinical Trials Medical Group, Inc. (CCT) and Behavior Medical Research LLC, which provided the company with a broad range of specialty Phase I-IV clinical research services through sites in California. The acquisition expanded PAREXEL’s early phase bed capacity, now currently 580 beds globally, and brought new service offerings in the area of bridging studies, as well as expertise in neuroscience drug development, central nervous system, and sleep studies.
Also in 2006 PAREXEL entered into a joint venture arrangement with Synchron, an India-based clinical research organization, to form PAREXEL International Synchron Private Limited, to provide Phase II-IV clinical research services in the country. The PAREXEL International Synchron Private Limited clinical trial business operations are located in Bangalore, India. PAREXEL also acquired a minority equity interest in the clinical pharmacology business of Synchron Research in Ahmedabad, India. PAREXEL subsequently opened its own office in Hyderabad, India in 2007, providing clinical research and data management services from the location.
Controversies
TeGenero Clinical Trial
Main article: TGN1412In March 2006, a PAREXEL-run trial on behalf of TeGenero, the now bankrupt German biotechnology firm, on its anti-inflammatory drug TGN1412 to treat rheumatoid arthritis, multiple sclerosis or leukaemia, unexpectedly caused severe inflammation and multiple organ failure in six healthy volunteers at a facility based at Northwick Park Hospital in London.[4] The drug had been tested on animals but this was the first test on humans.
PAREXEL became the target of legal proceedings from lawyers representing the injured volunteers after the insurance policy of TeGenero was unable to provide sufficient compensation. When the liable company[5] subsequently declared bankruptcy,[6] lawyers for the volunteers initiated legal proceeding against PAREXEL and the two parties later entered into talks;[7] the results of this meeting have not been made public.[8][9]
A documentary shown in the UK on 28 September 2006 featuring journalist Brian Deer as part of Channel 4's Dispatches series exposed uncertainty about the existence of data that should mandatorily have been submitted by TeGenero to the Medicines and Healthcare products Regulatory Agency (MHRA) prior to the trial indicating whether TGN1412 had been adequately tested on human blood in vitro. Concerns were also raised about whether a safe human dosage was properly obtained by TeGenero. The MHRA however concluded that none of the companies involved could be held responsible for the outcome of the test and that the adverse events that occurred were most likely caused by an unpredicted biological action of the drug in humans.[10]
References
- ^ a b "History of PAREXEL". Parexel. Archived from the original on 2007-10-19. http://web.archive.org/web/20071019053929/http://www.parexel.com/company/history/default.cfm. Retrieved 2007-12-28.
- ^ "About PAREXEL". Parexel. http://www.parexel.com/about.html. Retrieved 2009-04-19.
- ^ "Case Studies". Parexel. http://www.parexel.com/about/company/casestudies.html. Retrieved 2008-04-02.
- ^ "Drugs trial men 'seriously ill'". BBC News. March 15, 2006. http://news.bbc.co.uk/1/hi/england/london/4808836.stm.
- ^ "When drug trials go horribly wrong". The International Herald Tribune. April 9, 2006. http://www.iht.com/articles/2006/04/07/news/drug.php. Retrieved 2007-12-18.
- ^ "Will Parexel Settle? TeGenero Litigation". ClinPage. March 19, 2007. http://www.clinpage.com/article/tegenero_litigation/C7. Retrieved 2007-12-18.
- ^ "Window is open for compensation in TGN1412 case". PharmaTimes. March 14, 2007. http://www.pharmatimes.com/ClinicalNews/article.aspx?id=10534. Retrieved 2007-12-18.
- ^ "PAREXEL INTERNATIONAL STATEMENT REGARDING TEGENERO AG PHASE I TRIAL AT NORTHWICK PARK HOSPITAL, U.K." (Press release). Parexel. May 25, 2006. http://www.parexel.com/news-and-events/press-releases/default.cfm?pressID=58. Retrieved 2007-12-18.
- ^ "PAREXEL INTERNATIONAL STATEMENT REGARDING PHASE I REPORT BY U.K. EXPERT SCIENTIFIC GROUP" (Press release). Parexel. December 8, 2006. http://www.parexel.com/news-and-events/press-releases/default.cfm?pressID=32. Retrieved 2007-12-18.
- ^ Clinical trial final report, MHRA, 25 May 2006
External links
- PAREXEL International
- PAREXEL Clinical Trials
- PAREXEL Consulting
- PAREXEL Medical Communication Services
- Perceptive Informatics, a PAREXEL Company
- Barnett International, a division of PAREXEL
- PAREXEL Academy Berlin/Germany
- PAREXEL APEX International Clinical Research Co., Ltd.
- [http://www.piribo.com/publications/research_development/parexels_pharmaceutical_rd_statistical_sourcebook_20062007.html PAREXEL's Pharmaceutical R&D S
- PAREXEL International
- PAREXEL Jobs
Statistical Sourcebook 2006/2007]
Categories:- Biotechnology companies
- Companies based in Massachusetts
- Contract research organizations
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