PSI CRO Launches a Global Phase III Rare Disease Trial

In Press Release by Cameron


July 22, 2014

PSI CRO, a full-service contract research organization, announced today the launch of a new global study in Polycythemia vera in collaboration with AOP Orphan. PSI is setting up this 100-patient open-label, multicenter study at 45 sites across 13 countries globally.

The new project is a result of a successful collaboration on an earlier phase III study of 250+ patients in Polycythemia vera that PSI is managing for AOP Orphan globally. The study is enrolling right on time.

About Polycythemia vera:

Polycythemia vera (PV) is a Rare Disease of the blood-building cells in the bone marrow primarily resulting in a chronic increase of red blood cells (erythrocytes), thereby having an adverse impact on blood rheology. Circulatory disorders such as thrombosis and embolism, as well as malignant transformation to myelofibrosis or leukemia, are possible outcomes of the disease. With proper treatment, the majority of PV patients have a near-normal life expectancy.

About AOP Orphan Pharmaceuticals AG (AOP Orphan):

AOP Orphan is a multinational Austrian company with a strong focus on clinical research, development and distribution of medicines for rare and complex diseases. Supplying patients and medical specialists with such medication requires the provision of extended services. Big global companies encounter frequent problems in serving such market segments optimally, a fact reflected in the rapid growth of AOP Orphan as we provide individualized and customized services to meet and accommodate for the needs of physicians and patients. AOP Orphan provides its services across all Central Europe, Middle East & Asia. Currently AOP Orphan is concentrating on orphan and complex diseases in hematology / oncology, cardiology, pulmonology, intensive care medicine, neurology and psychiatry.


PSI is a privately-held, full-service contract research organization (CRO), operating globally with 1,400 staff worldwide. PSI positions itself as a no-nonsense CRO capable of saving pharmaceutical sponsors millions of development dollars by consistently meeting clinical trial timelines. PSI’s global reach supports the operations of clinical trials across multiple countries and continents. Global headquarters are located in Zug, Switzerland at 113a Baarerstrasse 6300.