Oncohematology lowres

Oncohematology Clinical Trials

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www.psi-cro.com

ONCOHEMATOLOGY

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Oncohematology Clinical Trials

Approved

www.psi-cro.com

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 18 years in the industry PSI still enjoys a solid reputation and grows mainly through repeat and referral business.

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ACUTE MYELOID LEUKEMIA REGULATORY CONSULTANCY FEASIBILITY STUDY HODGKIN’S LYMPHOMA ANAPLASTIC LARGE CELL LYMPHOMA 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 MULTIPLE MYELOMA CHRONIC MYELOID LEUKEMIA SITES ENROLLMENT READY NON-HODGKIN’S LYMPHOMA FIRST PATIENT IN SECONDARY ACUTE MYELOID LEUKEMIA CHEMO INDUCED NEUTROPENIA LAST PATIENT IN LAST PATIENT OUT CHRONIC LYMPHOCYTIC LEUKEMIA LOCK DATABASE FINALIZE INTEGRATED REPORT

ON TIME AHEAD AHEAD ON TIME AHEAD ON TIME ON TIME AHEAD AHEAD AHEAD ON TIME AHEAD ON TIME

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 carefully assess opportunities and only bid on those we believe we can do well.

• 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. • We stand by our operational promises and offer to develop a contract where we are remunerated when we reach delivery milestones.

Feasibility Completed: Ahead of schedule

Protocol Completed: On-Time

TICAL LOG7I.0S6.2013

MEDICAL

1

FEASIBILITY In recent years, our specialists have conducted hundreds of feasibility assessments for oncohematology 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. We weigh all of these factors before making recommendations.

We give every project a thorough assessment through our dedicated, full-time Feasibility Department. With people located in 11 countries of North America, Europe, Asia and Latin America and led by our team of internal oncologists, medical doctors, laboratory experts, imaging specialists, logisticians, pharmacy and regulatory experts, PSI predicts accurate dates for the enrollment of the first and last patients.

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 Comprehensive Project Plan: On-Time

Database Lock: Ahead of Schedule

ONCOHEMATOLOGY Conducting trials in Oncohematology indications is one of the core therapeutic strengths at PSI. In recent years, PSI has run numerous studies in oncohematology indications, encompassing blood dyscrasias from the more mundane to the rarest forms of liquid tumors. It is remarkable that over 95% of PSI’s oncohematology studies completed patient recruitment either on- time or ahead of schedule. The sites managed by PSI have consistently shown stellar performance. þ

þ

PSI HAS THE FOLLOWING PHASE I-IV EXPERIENCE IN ONCOHEMATOLOGICAL INDICATIONS:

More than 85 % of PSI’s operational staff has oncohematology 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. With a low staff turnover rate of <5%, PSI continues to accumulate knowledge in a multitude of liquid tumors where numerous challenges abound. These are some of the most difficult studies to conduct and PSI’s in-house familiarity with the nuances will benefit your team.

Acute Myeloid Leukemia Hodgkin’s Lymphoma Anaplastic Large Cell Lymphoma Multiple Myeloma Chemo Induced Neutropenia Non-Hodgkin’s Lymphoma Chronic Lymphocytic Leukemia Relapsed Multiple Myeloma Chronic Myeloid Leukemia Secondary Acute Myeloid Leukemia Follicular Non-Hodgkin's Lymphoma

PSI Global Oncohematology Trials

PSI’s dedicated Feasibility Department, comprised of medical specialists, laboratory experts, imaging specialists, logisticians and regulatory experts, has conducted feasibility across a wide range of oncohematology indications.When we apply this process to your trial and combine it with our knowledge of the smallest details and the largest challenges of such intricate protocols, we are able to provide recommendations for the best choice of sites, geography and realistic timelines for your study.

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

SAPs

MULTIPLE MYELOMA PHASE III

MULTIPLE

MYELOMA

16 countries/80+ sites Enrollment Period: 28 months Enrollment completed: original commitment 3 months ahead of schedule Additional enrollment at the request of our Sponsor, enrolled an additional 40+ patients for an overall reduction of enrollment time by one month.

Drug approved by the FDA MYELODY SPLA SYNDRO STIC ME

D MIA AN LEUKE OMA LYMPH LEUKEM

IA

Study Filings with Competent Authorities: On-Time

Sites Enrollment Ready: On-Time

ACUTE MYELOID LEUKEMIA PHASE IIB 60 years of age and older with previously untreated AML 5 countries/38 sites Enrollment Period: 17 months vs projected 18 months Enrollment completed one month ahead of schedule

LEUKE

MIA

HODGKINS

LYMPHOMA

CHRONIC MYELOID LEUKEMIA PHASE IIIB 7 countries/22 sites Enrollment Period: 11 months

NON-HO

DGKINS

LYMPHO

MA

Enrollment completed on time

BONE

OR

W DON

MARRO

BLOO

D CAN

Safety Database Set-up: On-Time

CER

Final Statistical Analysis: Ahead of Schedule

ent treatm & s i nos - diag notes

On-Time Enrollment

250 Physicians On-Board

On-Time Project Delivery