Us hematology

HEMATOLOGY

Hematology Clinical Trials

Approved

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SAPs

Study Filings with Competent Authorities: On-Time Sites Enrollment Ready: On-Time

hemophilia B - Phase III

hemophilia A or b - Phase I

hemophilia a or b - Phase III

hemophilia A - phase iii/v

hemophilia b - Phase iv

hemophilia b - phase i/iii

Safety Database Set-up: On-Time

Final Statistical Analysis: Ahead of Schedule

HEMATOLOGY In recent years, PSI has run numerous studies in hematology, encompassing blood dyscrasias from the more mundane to the rarest forms of hemophilia. It is remarkable that over 95% of PSI’s hematology studies completed patient recruitment either on-time or ahead of schedule. The sites managed by PSI have consistently shown stellar performance. þ

More than 50% of PSI’s operational staff has hematology experience, thereby providing expertise to our sponsors in all aspects of planning, leveraging investigator relationships, reviewing protocol complexities and executing all aspects of clinical trials that will end on-time and on-budget.

þ

PSI has conducted studies in different hemophilia populations: Hemophilia A and B, previously treated and previously untreated, with and without inhibitors, adult and pediatric, on prophylactic and on-demand treatment, undergoing minor and major surgical procedures. We have worked with plasma-derived and recombinant FVIII and FIX concentrates, as well as bypassing agents.

þ

PSI has worked with 150+ hemophilia treatment centers, globally, including KOLs from Europe & North America. We have a database of 400+ known, potential hemophilia sites, which have taken part in the feasibility process for each program we have undertaken.

Last Patient In: Ahead of schedule

Last Patient Out: Ahead of schedule

PSI HAS THE FOLLOWING PHASE I-IV EXPERIENCE IN HEMATOLOGICAL INDICATIONS: Acute Anemia Idiopathic Thrombocytopenic Purpura Polycythemia Vera Hemophilia A (includes Pediatric) Hemophilia B (includes Pediatric) Thrombocytopenia Thrombotic Thrombocytopenic Purpura (TTP) Paroxysmal Nocturnal Hemoglobinuria (PNH) Von Willebrand Disease

First Patient In: On-Time

Last Patient In: Ahead of schedule

PSI Global Hematology Trials

First Patient In: On-Time

Last Patient In: Ahead of schedule

HEMOPHILIA A REGULATORY CONSULTANCY FEASIBILITY STUDY POLYCYTHEMIA VERA THROMBOCYTOPENIA 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 VON WILLEBRAND DISEASE HEMOPHILIA B SITES ENROLLMENT READY ACUTE ANEMIA FIRST PATIENT IN PAROXYSMAL NOCTURNAL HEMOGLOBINURIA THROMBOTIC THROMBOCYTOPENIC PURPURA LAST PATIENT IN LAST PATIENT OUT IDIOPATHIC THROMBOCYTOPENIC PURPURA 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

TICAL LOG7I.0S6.2013

MEDICAL

1

FEASIBILITY The upfront investment of time and medical expertise into each feasibility assessment underlies PSIs patient enrollment success in hematology trials.

We give every project a thorough assessment through our dedicated, full-time Feasibility Department. 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. We weigh all of these factors before making recommendations.

PSI has worked with 150+ hemophilia treatment centers including KOLs from Europe & North America. We have a database of 400+ known, potential hemophilia sites in 40+ countries, which have taken part in the feasibility process for each program we have undertaken.

Our value-added feasibility assessments for regional or global programs provide our sponsors with the best choice of sites & geography, ensuring predictable and accurate enrollment projections.

.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.

Comprehensive Project Plan: On-Time

Database Lock: Ahead of Schedule

THE PSI STORY Being a full service CRO is challenging in its own right. But being a CRO that takes the unique approach of ‘pitching’ on-time project delivery in today’s changing global environment takes it to the limit. The majority of our global projects have milestone-driven payment schedules and clients do not pay until they see results. This is a tough measure of success, and people who work at PSI know that better than anyone.

We believe that PSI’s approach and performance addresses the biggest challenge in our industry. According to various sources, more than 90% of trials run behind schedule, costing sponsors millions of $$ in delays to market. Contrary to ‘normal’ industry performance, 95% of PSI studies finish on-time or ahead of schedule. This may sound incredible to many; however, such sustainable results are not a miracle.

It’s what happens when dedicated employees focus their proficiency and a client-centric approach on two things; in-depth feasibility and ‘go the extra mile’ project management.

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 employees 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.

On-Time Enrollment

250 Physicians On-Board

On-Time Project Delivery

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