INFECTIOUS DISEASE The study of Infectious Diseases is one of the core Therapeutic Areas for PSI. In the past five years, PSI has conducted over 40 infectious disease programs (Phase I-III). It is remarkable that every one of PSI’s ID studies completed patient recruitment either on or ahead of schedule. The infectious disease sites managed by PSI have consistently shown stellar performance. PSI has developed an extensive database of excellent sites worldwide, covering all types of infections. The geographical span for PSI’s ID experience includes North America, Latin America, South Africa, Australia, India and Europe. PSI has participated in several FDA site inspections for ID studies, passing them without any findings, major or minor. In the past two years, two infectious disease products were approved by the FDA on the strength of data coming from PSI’s sites. Highlights of PSI’s expertise in this area:
þ We have established healthy relationships with the sites and have built unique connections with an invaluable network of Key Opinion Leaders at the local, regional, and national levels.
þ Our very knowledgeable and highly experienced Medical Affairs team, which is available to support ID studies, keeps PSI on the cutting edge of global antibacterial, antiviral and antifungal drug development. þ More than 60% of PSI’s operational staff has infectious disease experience. They provide our sponsors with expertise in all aspects of planning, leveraging investigator relationships, reviewing protocol complexities and executing all aspects of a clinical trial, ending studies on time and on budget. It þPSI maintains a full time staff of laboratory experts as part of has been truly a our Medical Affairs Group. Numerous MDs, PhDs and pleasure working with PSI on the [drug] Masters trained personnel, who specialize in microbiology, program. The PSI team has laboratory procedures and logistics, comprise this group. consistently delivered on all PSI has wide-ranging familiarity in working with regional projects, and I thank you for all your hard work and labs, site labs and central labs for ID programs.
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dedication to the trials. I hope that we will have a chance to work together once again in the future. Senior Medical Director, USA
þ 250+ of our staff members hold Medical Degrees and many possess board certifications in specialties such as infectious diseases, internal medicine, pediatrics and pulmonology. We have all the means to ensure that a team of experts will run your study.
PSI has the following Phase II-IV experience in various Infectious Disease types that includes anti-bacterial, anti-viral, anti-fungal and vaccines: ABSSSI
†
Hospital Acquired Pneumonia
Chronic Bronchitis
Intra Abdominal Infections
Community Acquired Pneumonia
Oropharyngeal Candidiasis ††
Complicated Urinary Tract Infections
Respiratory Syncytial Virus †
Hepatitis B
Sepsis
Hepatitis C
Vaccines †
Herpes Simplex Labialis ††
Ventilator Acquired Pneumonia
includes Pediatric subjects includes HIV subjects
††
WWW.PSI-CRO.COM PSI CRO AG Corporate Headquarters Baarerstrasse 113a, 6300 Zug, Switzerland • Tel: +41 41 228 10 00
Global Office Locations North America: Ft. Washington, PA / Burlingame, CA / San Francisco, CA Latin America: Buenos Aires, Argentina Europe: Oxford, UK / Munich, Germany / Neusiedl am See, Austria Minsk, Belarus / Sofia, Bulgaria / Prague, Czech Republic / Tallinn, Estonia Budapest, Hungary / Milan, Italy / Warsaw, Poland / Bucharest, Romania Belgrade, Serbia / Kiev, Ukraine Russian Federation: St. Petersburg, Moscow, Novosibirsk
Operational Presence by Region North America / Europe / Latin America Asia-Pacific / South Africa