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INFECTIOUS DISEASES


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PSI’s strength is in its people and their attitude. The PSI management team that founded the company 18+ 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.

Infectious Diseases Clinical Trials

www.psi-cro.com

THE PSI STORY

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 18+ 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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ON TIME ON TIME AHEAD ON TIME AHEAD ON TIME ON TIME AHEAD AHEAD AHEAD ON TIME AHEAD 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.

Feasibility Completed: Ahead of schedule

Protocol Completed: On-Time


MEDICAL

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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 programs 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.

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I CLIN Comprehensive Project Plan: On-Time

Database Lock: Ahead of Schedule


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. 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.

First Patient In: On-Time

Last Patient In: Ahead of schedule

Last Patient Out: Ahead of schedule

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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.

First Patient In: On-Time

Last Patient In: Ahead of schedule


SAPs 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, anti-fungal and vaccines: ABSSSI Chronic Bronchitis 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 Vaccines † Ventilator Acquired Pneumonia †

includes Pediatric Subjects includes HIV subjects

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Study Filings with Competent Authorities: On-Time

Sites Enrollment Ready: On-Time


The the geographical span for our ID experience includes North America, Latin America, South Africa, Australia, India and Europe.

Map of PSI Global Antibiotic Trials

Safety Database Set-up: On-Time

Final Statistical Analysis: Ahead of Schedule


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On-Time Enrollment

250 Physicians On-Board

On-Time Project Delivery


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