Page 1

HEMATOLOGY & ONCOHEMATOLOGY Conducting trials in Hematology and Oncohematology are two of PSI’s core therapeutic strengths. In recent years, PSI has run numerous studies in hematology, encompassing blood dyscrasias from the more mundane to the rarest forms of hemophilia. Not to be overlooked, we have tackled the study of the most difficult liquid tumor types as well. It is remarkable that over 90% of PSI’s hematology/oncohematology studies completed patient recruitment either on- time or ahead of schedule. The sites managed by PSI have consistently shown stellar performance.

þMore than 50% of PSI’s operational staff has hematology/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 <6%, PSI continues to accumulate knowledge in a multitude of blood dyscrasias and 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. þWe have operational teams consisting of members of Senior Project Management, Project Management, CRAs and Medical Affairs who focus on hematology and liquid tumors.

þPSI 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. þPSI 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. þ PSI

The PSI team exceeded

has conducted studies in oncohematology expectations, and malignancies including Multiple Myeloma, NHL, CLL, AML, execution of the protocol was and Hodgkin’s Lymphoma at sites across Western, exemplary. I’m proud of our Central and Eastern Europe, Latin America, Australia and joint team and am grateful to the US. have worked together.

For more information about PSI, please visit our website WWW.PSI-CRO.COM or reach us at CONTACT@PSI-CRO.COM

Clinical Project Manager, USA

þPSI’s dedicated Feasibility Department, comprised of medical specialists, laboratory experts, imaging specialists, logisticians and regulatory experts, has conducted feasibility across a wide range of hematology and 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. PSI has the following Phase I-IV experience in hematological indications: Hematology Indications

Oncohematology Indications

Acute Anemia

Acute Myeloid Leukemia

Atypical Hemolytic Uremic Syndrome

Anaplastic Large Cell Lymphoma

Idiopathic Thrombocytopenic Purpura

Chemo Induced Neutropenia

Polycythemia Vera

Chronic Lymphocytic Leukemia

Hemophilia A (includes Pediatric)

Chronic Myeloid Leukemia

Hemophilia B (includes Pediatric)

Follicular Non-Hodgkin's Lymphoma


Hodgkin’s Lymphoma

Thrombotic Thrombocytopenic Purpura (TTP)

Multiple Myeloma

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Non-Hodgkin’s Lymphoma

Von Willebrand Disease

Relapsed Multiple Myeloma Secondary Acute Myeloid Leukemia

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

Us new hematology