User talk:Thessence
| [[Image:|PSI logo]] | |
| Company type | Private |
|---|---|
| Industry | Contract Research Organizations Pharma Services Consulting |
| Founded | 1995 |
| Headquarters | Zug, Switzerland |
| Products | clinical drug development services for pharmaceutical and biotech industry |
Number of employees | ~1,000 (2009) |
| Website | www.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]
- ^ "PSI Overview".
- ^ "Clinical Trials in Central and South Eastern Europe".
- ^ "Centerwatch - Industry news"
- ^ "PSI aces FDA inspections"
- ^ "PSI Facts & Figures"
- ^ [http://annonc.oxfordjournals.org/cgi/reprint/mdl104v1.pdf "Abraxane, a novel Cremophor-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer - M. R. Green1, G. M. Manikhas, S. Orlov, B. Afanasyev, A. M. Makhson, P. Bhar & M. J. Hawkins"]
- ^ "Ferring pharmaceuticals completes phase III study of degarelix in prostate cancer patients"
- ^ "PSI strengthens its position as a fast-enrolling CRO"
- ^ "PSI gains a firm foothold in Latin America"
- ^ "PSI Acquires Latin American CRO Thywill"
- ^ "Generex Biotechnology Appoints Leading Contract Research Organization to Manage Global Phase III Trials For Generex Oral-Lyn"
- ^ "Sponsor’s experience and vision of the future - Elena Bolaños, PhD, MBA
- ^ "CNN - Drug testing goes offshore"
External links[edit]
Orphaned non-free image (File:PSI corporate logo.jpg)[edit]
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Your user page reads like an advertisement[edit]
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