PAREXEL

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PAREXEL International
Type Public
Traded as NASDAQPRXL
Industry Clinical research organizations
Pharmaceutical
Founded 1982
Headquarters Waltham, Massachusetts, United States of America;
76+ facilities in 50+ countries
Key people Chairman and CEO:
Josef H. von Rickenbach
Services clinical trial management, data management, medical writing, biostatistics, pharmacovigilance, regulatory consulting
Revenue Increase$1.734B for FY13
Employees 15,890[1]
Website www.parexel.com

PAREXEL International is a multinational contract research organization (CRO), based in Waltham, 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.[2] PAREXEL employs more than 15,000 people worldwide in over 50 countries[3] and has supported leading biotechnology companies and several large pharmaceutical companies[2] to bring new drugs to the market.[4]The company has been ranked to FlexJobs' list of 100 Top Companies for Remote Jobs in 2014.[5]

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 eClinical technology solutions.

Careers[edit]

PAREXEL hired approximately 830 employees worldwide during Fiscal Year 2011. Typical jobs at PAREXEL include clinical research professionals, as well as data management and biostatistical experts to support the conduct of clinical study programs worldwide. Other positions include consultants who have experience in regulatory affairs, product development, reimbursement, commercialization and market access. PAREXEL offers jobs in many functional areas to support its worldwide infrastructure, including many positions in Information Technology (IT), on a global basis.

Awards and recognition[edit]

PAREXEL won “Clinical Research Team of the Year” in 2010 and "CRO of the Year" in 2008 in The Scrip Awards. Chairman and CEO Josef von Rickenbach was named Executive of the Year North America in the 2010 International Business Awards, also known as the Stevies. In 2011, PAREXEL was named as Company of the Year for the Pharmaceutical Industry in the International Business Awards. Also in 2011, the Company was recognized as a “Best 5 Outsourcing Company to the Pharmaceutical Industry” as part of the Global Outsourcing 100. PAREXEL was previously recognized as “Best Performing CRO in Asia” by the BioSingapore Association.

Chief Operating Officer (COO), Mark A. Goldberg, M.D., was honored by the Academy of Physicians in Clinical Research (APCR). Dr. Goldberg was recognized for his contributions to the advancement of clinical research during the awards ceremony and reception at the Association of Clinical Research Professionals (ACRP) 2012 Global Conference & Exhibition in Houston, Texas on April 15, 2012. Dr. Goldberg was honored with this year’s APCR Special Recognition Award for his embodiment of APCR’s values and for the advancement of clinical research by combining his medical knowledge and development expertise with the application of information technology. The APCR Special Recognition Award is presented annually to an individual who has demonstrated exceptional performance, achievement and sustained service toward the goals of the APCR, and has made significant contributions to the betterment of the APCR overall. Past recipients include: Senator Edward Kennedy in 2008, Robert J. Levine in 2009, Robert M. Califf in 2010 and Carl Peck in 2011.

Partnership deals and clients[edit]

During 2010-2011, PAREXEL signed several strategic partnership agreements with major pharmaceutical companies including Bristol-Myers Squibb, Eli Lilly, GSK, Merck BioVentures and Pfizer. These partnerships provide strategic and operational support for development pipelines and bring greater efficiencies to clinical research.

PAREXEL works with pharmaceutical, medical device and biotech companies of all sizes that leverage its global resources, worldwide infrastructure, and experience with a focus on helping companies to make early-stage decisions about their compounds, reduce development timelines, and access global markets to bring new medical treatments to patients sooner. The Company’s client base includes the top 50 biopharmaceutical companies, top 10 biotech companies and hundreds of small and emerging biopharmaceutical companies.

PAREXEL Academy[edit]

PAREXEL Academy is a provider of education and professional training for the biopharmaceutical industry in the field of clinical research. Offering professional training and education since 2001, PAREXEL Academy, based in Berlin, Germany, provides postgraduate courses for clinical research associates, study nurses, and study coordinators. Training courses are also provided for investigators with special emphasis on conducting clinical trials in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards.

On October 10, 2011 PAREXEL and the National University of Singapore established a program in Singapore to meet increasing demand in Asia for clinical research talent. The academic program focused on global best practices and the latest advances in the industry. PAREXEL Academy graduated the first class from its Bachelor of Science (BSc) in Clinical Research program on July 7, 2011. PAREXEL Academy launched the BSc program in 2008 to award one of the first internationally accredited undergraduate degrees in clinical research, which is validated by the University of Wales.

Recent acquisitions[edit]

In December 2012, PAREXEL announced the acquisition of Liquent, Inc., a leading global provider of Regulatory Information Management (RIM) solutions. Liquent provided an integrated platform of software solutions for regulatory submissions and product registration management, as well as a range of complementary business process outsourcing capabilities.[6]

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.

Controversies[edit]

TeGenero Clinical Trial[edit]

Main article: TGN1412

In 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.[7] 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[8] subsequently declared bankruptcy,[9] lawyers for the volunteers initiated legal proceeding against PAREXEL and the two parties later entered into talks;[10] the results of this meeting have not been made public.[11][12]

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.[13]

See also[edit]

References[edit]

  1. ^ http://www.parexel.com/company
  2. ^ a b "History of PAREXEL". Parexel. Archived from the original on 2007-10-19. Retrieved 2007-12-28. 
  3. ^ "About PAREXEL". Parexel. Retrieved 2009-04-19. 
  4. ^ "Case Studies". Parexel. Retrieved 2008-04-02. 
  5. ^ "PAREXEL Featured Among FlexJobs "Top 100 Companies For Flexible Jobs" In 2014". Yahoo Finance. 2014-03-01. Retrieved 2014-03-02. 
  6. ^ "PAREXEL INTERNATIONAL ANNOUNCES ACQUISITION OF LIQUENT, INC., AND UPDATES FINANCIAL GUIDANCE". Parexel. Retrieved 19 February 2014. 
  7. ^ "Drugs trial men 'seriously ill'". BBC News. March 15, 2006. 
  8. ^ "When drug trials go horribly wrong". The International Herald Tribune. April 9, 2006. Retrieved 2007-12-18. 
  9. ^ "Will Parexel Settle? TeGenero Litigation". ClinPage. March 19, 2007. Retrieved 2007-12-18. 
  10. ^ "Window is open for compensation in TGN1412 case". PharmaTimes. March 14, 2007. Retrieved 2007-12-18. 
  11. ^ "PAREXEL INTERNATIONAL STATEMENT REGARDING TEGENERO AG PHASE I TRIAL AT NORTHWICK PARK HOSPITAL, U.K." (Press release). Parexel. May 25, 2006. Retrieved 2007-12-18. 
  12. ^ "PAREXEL INTERNATIONAL STATEMENT REGARDING PHASE I REPORT BY U.K. EXPERT SCIENTIFIC GROUP" (Press release). Parexel. December 8, 2006. Retrieved 2007-12-18. 
  13. ^ Clinical trial final report, MHRA, 25 May 2006

External links[edit]