INFECTIOUS DISEASES
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PROGRAM OF 2 STUDIES IN URINARY TRACT INFECTION – PHASE III
Approved
Population: Complicated Urinary Tract Infection, including Pyelonephritis Study Design: double-blind, randomized 42 sites in Europe Drug type: New-generation cephalosporin Enrollment Completed On-Time
Infectious Diseases Clinical Trials
www.psi-cro.com
ENROLLMENT GRAPHS SA
First Patient In: On-Time
Last Patient In: Ahead of schedule
COMPLICATED INTRA-ABDOMINAL INFECTION – PHASE III Population: Acute Hospitalized subjects with a diagnosis of cIAI (requiring surgery) 13 countries/101 sites 541 patients randomized 4 months ahead of schedule
Last Patient Out: Ahead of schedule
First Patient In: On-Time
SAPs
OUR EXPERTISE PSI has been named one of the most successful antimicrobial CROs in the industry. In recent years, we have conducted 50+ infectious diseases programs (Phase I-III). From the beginning we have differentiated ourselves by creating robust methodology to help developers of antimicrobial compounds prove the reliability and efficacy of their drug products. It is remarkable that every one of our studies completed patient recruitment either on or ahead of schedule. The infectious diseases sites managed by PSI have consistently shown stellar performance. Ăž
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.
Study Filings with Competent Authorities: On-Time
Sites Enrollment Ready: On-Time
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Conducting Robust Feasibility: PSI is an expert at conducting feasibility studies that provide excellent sites and accurate recruitment forecasts by understanding country and site antibiotic resistance differences.
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PSI maintains a full time staff of laboratory experts who specialize in microbiology, laboratory procedures and logistics. PSI has wide-ranging familiarity in working with regional labs, site labs and central labs for ID programs.
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More than 60% of PSI’s operational staff has infectious diseases 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.
Safety Database Set-up: On-Time
Final Statistical Analysis: Ahead of Schedule
Today, PSI is running thousand-patient programs in acute care indications across several continents that include: Skin Infections, Intra-abdominal infections, Urinary Tract Infections, Abscesses and Pneumonias. PSI has the following Phase II-IV experience in various Infectious Diseases types that includes anti-bacterial, anti-viral, and anti-fungal:
The the geographical span for our ID experience includes North America, Latin America, South Africa, Australia, India and Europe.
ABSSSI Chronic Bronchitis
Map of PSI Global Antibiotic Trials
Community Acquired Pneumonia Complicated Urinary Tract Infections Hepatitis B Hepatitis C Herpes Simplex Labialis †† Hospital Acquired Pneumonia Intra Abdominal Infections Oropharyngeal Candidiasis †† Respiratory Syncytial Virus † Sepsis Influenza † Ventilator Acquired Pneumonia †
includes Pediatric Subjects includes HIV subjects
††
First Patient In: On-Time
Last Patient In: Ahead of schedule
Last Patient Out: Ahead of schedule
First Patient In: On-Time
Last Patient In: Ahead of schedule
SEPSIS REGULATORY CONSULTANCY FEASIBILITY STUDY UTI HEPATITIS C CREATE CRF SET UP STUDY DATABASE STATS ANALYSIS PLAN SITE SELECTION SET UP STUDY LOGISTICS STUDY FILING WITH COMPETENT AUTHORITIES
AHEAD ON TIME ON TIME AHEAD ON TIME AHEAD AHEAD ON TIME ON TIME ON TIME
SITE CONTRACTS ABSSSI COMMUNITY ACQUIRED PNEUMONIA SITES ENROLLMENT READY INFLUENZA FIRST PATIENT IN HEPATITIS B RESPIRATORY SYNCYTIAL VIRUS LAST PATIENT IN LAST PATIENT OUT INTRA ABDOMINAL INFECTIONS LOCK DATABASE FINALIZE INTEGRATED REPORT
ON TIME ON TIME AHEAD ON TIME AHEAD ON TIME ON TIME AHEAD AHEAD AHEAD ON TIME AHEAD ON TIME
ON TIME
MEDICAL
TICAL LOG7I.0S6.2013 1
FEASIBILITY PSI is an expert at conducting regional or global feasibility that provides the best choice of sites and geography with accurate recruitment forecasts. In recent years, our specialists located in 11 countries of North America, Europe, Asia and Latin America have conducted hundreds of feasibility assessments for infectious diseases studies in 50+ countries. These assessments cover, but are not restricted to, evaluation of the target population availability and factors that limit it, standards of care, competitive studies, regulatory climates and the need to engage particular Key Opinion Leaders into the study. In addition there also critical success factors for antimicrobial trials; understanding country and site antibiotic resistant differences, validation of lab standards. We weigh all of these factors before making recommendations on the best choice of sites and geography for your program. 95% of our studies are finished on time or ahead of schedule.
.2013
25.10
CAL
I CLIN Feasibility Completed: Ahead of schedule
Protocol Completed: On-Time
ACCOUNTABILITY PSI’s reputation is that of a no-nonsense CRO that delivers by taking the right actions even when that is the harder path. However well one plans a study, the unexpected will happen. What differentiates a good vendor from everyone else is the manner in which difficulties are managed. At PSI, studies enroll on time not only because they are well-planned, but also because the project teams assume an attitude of “get it done or die trying”. Most of the projects we undertake are “tough”. PSI has won many unwinnable battles by sheer persistence in an effort to keep our promises to our clients. To us, doing the right thing means: • We do our best to keep your expectations in line with reality because we are accountable for every promise we make. • We speak our truth even if it is not what you expect to hear. We wish to guide you on the right path, not let you believe something just because it is what you want to hear. • We show you how we can meet your study timelines by telling you which countries can enroll and how to realistically integrate the contributions of strategically important regions and KOLs.
On-Time Enrollment
250 Physicians On-Board
On-Time Project Delivery
THE PSI STORY PSI’s strength is in its people and their attitude. The PSI management team that founded the company 19 years ago is still here and fully engaged in day-to-day project life. “Navy seals of the CRO industry” was how one of our clients described PSI. In our industry more than 90% of clinical trials fall behind deadlines, while 95% of PSI studies finish on time or ahead of schedule. We subscribe to the belief that “it’s kind of fun to do the impossible”. We maintain our practice of investing in talent because we know that only devoted and accountable people can deliver the kind of service that will ensure outstanding results for our clients. Our mission is to be the best CRO in the world as measured by our clients and our employees. With 1,400 folks in 50+ countries we have a lot of talent to look after. Dozens of customers in a variety of therapeutic areas have come to PSI and stayed. Maybe that is why after 19 years in the industry PSI still enjoys a solid reputation and grows mainly through repeat and referral business. When combined, these characteristics yield tangible outcomes for our customers. Studies run on time and on budget and save hundreds of millions of development dollars.
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