PSI
Company typePrivate
IndustryContract Research Organizations
Pharma Services Consulting
Founded1995
HeadquartersZug, Switzerland
Productsclinical drug development services for pharmaceutical and biotech industry
Number of employees
~1,000 (2009)
Websitewww.psi-cro.com

PSI is a full-service contract research organization (CRO) with offices across Europe and the Americas, specializing in clinical drug development in all major therapeutic areas.[1] According to its website, PSI is distinguished by solid presence and expertise in the fast-enrolling countries of Eastern Europe and Latin America, regions that have become significant contributors of pivotal clinical trial data to global drug development programs.[2]

History

edit

Since its establishment in 1995, PSI has completed nearly 300 clinical trials [3] having enrolled more than 50,000 patients in a variety of therapeutic areas. PSI-managed investigative sites provided massive enrollment into pivotal registration programs. As a result, in the past 3 years, PSI was inspected by regulatory bodies in a number of countries of operation. Their sites have been inspected by the FDA 24 times [4] and twice by the EMEA [5].
PSI contributes significant amounts of data to pivotal trials. Abraxane®, Aloxi®, VESIcare®, Thalomid® and a number of other products received FDA approvals based on the majority of data coming from PSI’s sites. [6]. In 2009 Degarelix by Ferring Pharmaceuticals, for treatment of advanced prostate cancer, has reached the market with PSI’s help. [7] 98% of these studies have completed on or ahead of schedule [8] Each clinical study is always preceded by a thorough feasibility study allowing us to make an educated commitment to patient enrollment timelines.

Expansion

edit

In July 2008 PSI has completed acquisition of Thywill, a reputable CRO having its main offices in Buenos Aires, Argentina, and specializing in managing clinical trials throughout Latin America. [9] According to CenterWatch, the acquisition of Thywill represents PSI’s first acquisition since the company was established in 1995. Prior to the acquisition, PSI grew organically, establishing offices in Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Romania, Poland, Serbia, Russia, Ukraine and the U.S. [10]. By entering another region with high-enrolling potential PSI expanded its coverage of the globe. The addition of Argentina, Venezuela, Peru, Ecuador, Uruguay, Colombia, Chile and Mexico to PSI’s operational map further enhances the company’s core strengths. PSI’s primary Latin American office is in Buenos Aires, Argentina.

Services

edit

Some clients outsource their entire Phase II programmes to regions that can enroll a patient population quickly to speed up obtainment of proof-of-principle data. Some clients involve PSI globally [11], across Europe and the Americas.


Today, high enroling countries that consistently contribute massive amounts of data to pivotal registration trials happen to be in Eastern Europe and Latin America. PSI is one of the strongest CRO in these regions. It is the largest CRO in Eastern Europe - the region that has become a major provider of clinical trial data for international drug development sponsors. [12]. PSI doesn’t not rely on patient enrolment from the regions that are known to be slow. Their core strength is about enroling patients quickly and predictably. [13].


PSI provides diversified drug development services, including:

  • Global Project Management
  • Clinical Monitoring
  • Data Management
  • Biostatistics
  • Global Safety Reporting / Medical Monitoring / Pharmacovigilance
  • Regulatory Affairs
  • Clinical Trial Applications
  • Marketing Authorizations
  • Medical Writing
  • Customs Brokerage & Drug Depot Services
  • QA Audits
  • QP services for the EU including batch release
  • GMP-certified drug storage facilities in the EU with secondary packaging capabilities
  • Event Management
  • Technology Services
  • Translations into multiple languages
  • EU Legal Representation

See also

edit

References

edit
edit


Orphaned non-free image (File:PSI corporate logo.jpg)

edit
 

Thanks for uploading File:PSI corporate logo.jpg. The image description page currently specifies that the image is non-free and may only be used on Wikipedia under a claim of fair use. However, the image is currently orphaned, meaning that it is not used in any articles on Wikipedia. If the image was previously in an article, please go to the article and see why it was removed. You may add it back if you think that that will be useful. However, please note that images for which a replacement could be created are not acceptable for use on Wikipedia (see our policy for non-free media).

If you have uploaded other unlicensed media, please check whether they're used in any articles or not. You can find a list of "file" pages you have edited by clicking on the "my contributions" link (it is located at the very top of any Wikipedia page when you are logged in), and then selecting "File" from the dropdown box. Note that any non-free images not used in any articles will be deleted after seven days, as described on criteria for speedy deletion. Thank you. FileBot (talk) 10:44, 22 August 2009 (UTC)Reply

Your user page reads like an advertisement

edit

  Hello, and welcome to Wikipedia. I noticed that your user page may not meet Wikipedia's user page guideline. If you believe that your user page does not violate our guideline, please leave a note on this page. Alternatively you may add {{Db-userreq}} to the top of the page in question and an administrator will delete it, or you can simply edit the page so that it meets Wikipedia's user page guideline. Thank you. UseTheCommandLine (talk) 00:21, 22 January 2013 (UTC)Reply