Parexel
Encyclopedia
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. PAREXEL employs more than 9,000 people worldwide in over 50 countries and has supported all of the top 20 leading biotechnology companies, all of the top 10 largest pharmaceutical companies and nearly all of the 50 best-selling drugs on the market.
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.
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.
, 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
. 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 subsequently declared bankruptcy
, lawyers for the volunteers initiated legal proceeding against PAREXEL and the two parties later entered into talks; the results of this meeting have not been made public.
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.
Statistical Sourcebook 2006/2007
Contract research organization
A contract research organization, also called a clinical research organization, is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services...
(CRO), based in Lowell, Massachusetts
Lowell, Massachusetts
Lowell is a city in Middlesex County, Massachusetts, USA. According to the 2010 census, the city's population was 106,519. It is the fourth largest city in the state. Lowell and Cambridge are the county seats of Middlesex County...
and founded in 1982 by Josef H. von Rickenbach (still current CEO) and Anne Sayigh. It provides services for companies in the pharmaceutical
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
, biotechnology
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
and medical device industries, including consulting, clinical studies
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
and market launch. The name PAREXEL comes from Paracelsus
Paracelsus
Paracelsus was a German-Swiss Renaissance physician, botanist, alchemist, astrologer, and general occultist....
, a Swiss physician considered as the father of modern toxicology. PAREXEL employs more than 9,000 people worldwide in over 50 countries and has supported all of the top 20 leading biotechnology companies, all of the top 10 largest pharmaceutical companies and nearly all of the 50 best-selling drugs on the market.
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.
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 RandomizationRandomization
Randomization is the process of making something random; this means:* Generating a random permutation of a sequence .* Selecting a random sample of a population ....
and Trial Supply Management technologies, Electronic Data Capture
Electronic Data Capture
An Electronic Data Capture system is a computerized system designedfor the collection of clinical data in electronic format for use mainly in human clinical trials.Typically, EDC systems provide:* a graphical user interface component for data entry...
, 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.
TeGenero Clinical Trial
In March 2006, a PAREXEL-run trial on behalf of TeGeneroTeGenero
TeGenero AG was a pharmaceutical research company in Würzburg, Germany. It had 15 employees and was incorporated as an Aktiengesellschaft from 2002...
, the now bankrupt German biotechnology
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
firm, on its anti-inflammatory drug TGN1412
TGN1412
TGN1412 is the working name of an immunomodulatory drug which was withdrawn from development after inducing severe inflammatory reactions in the first human subjects to receive the drug....
to treat rheumatoid arthritis
Rheumatoid arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints. The process produces an inflammatory response of the synovium secondary to hyperplasia of synovial cells, excess synovial fluid, and the development...
, multiple sclerosis
Multiple sclerosis
Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
or leukaemia, unexpectedly caused severe inflammation and multiple organ failure in six healthy volunteers at a facility based at Northwick Park Hospital in London
London
London is the capital city of :England and the :United Kingdom, the largest metropolitan area in the United Kingdom, and the largest urban zone in the European Union by most measures. Located on the River Thames, London has been a major settlement for two millennia, its history going back to its...
. The drug had been tested on animals but this was the first test on humans
First-in-man study
A first-in-man study is a clinical trial where a medical procedure, previously developed and assessed through in vitro or animal testing, or through mathematical modelling is tested on human subjects for the first time....
.
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 subsequently declared bankruptcy
Bankruptcy
Bankruptcy is a legal status of an insolvent person or an organisation, that is, one that cannot repay the debts owed to creditors. In most jurisdictions bankruptcy is imposed by a court order, often initiated by the debtor....
, lawyers for the volunteers initiated legal proceeding against PAREXEL and the two parties later entered into talks; the results of this meeting have not been made public.
A documentary shown in the UK on 28 September 2006 featuring journalist Brian Deer
Brian Deer
Brian Deer is a British investigative reporter, best known for inquiries into the drug industry, medicine and social issues for the Sunday Times of London.- Career :...
as part of Channel 4
Channel 4
Channel 4 is a British public-service television broadcaster which began working on 2 November 1982. Although largely commercially self-funded, it is ultimately publicly owned; originally a subsidiary of the Independent Broadcasting Authority , the station is now owned and operated by the Channel...
'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
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
(MHRA) prior to the trial indicating whether TGN1412 had been adequately tested on human blood in vitro
In vitro
In vitro refers to studies in experimental biology that are conducted using components of an organism that have been isolated from their usual biological context in order to permit a more detailed or more convenient analysis than can be done with whole organisms. Colloquially, these experiments...
. 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.
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.
- PAREXEL's Pharmaceutical R&D S
- [http://www.parexel.com/ PAREXEL International]
- [http://jobs.parexel.com/ PAREXEL Jobs]
Statistical Sourcebook 2006/2007