Pharmaxi Background and Experience
Pharmaxi has been providing high-quality clinical research services to sponsors for more than five years now. Our history covers successful program management and support to biotech, pharmaceutical, and medical device companies across all Phases (I-IV), services and locations (North America, Central Europe and CIS countries). We have successfully performed over 20 studies spanning 10 countries. Pharmaxi has provided integrated key clinical research services for these projects, including protocol development, site selection, project and site management, monitoring, (e)CRF development, database development, data management, biostatistics, pharmacovigilance, regulatory support, and medical writing. Pharmaxi partners with clinical laboratories & clinical centers and engages with trusted, quality providers to cover a wide range of services (drug depot, logistics, insurance). Pharmaxi has also developed and validated an EDC system to enhance the efficiency of clinical trials, observational studies, and disease registries.
Additionally, the principles of Pharmaxi involve deep personal experience in clinical trial planning, management, and conduct. Two of them have been involved in Clinical Trials for more than 15 years.
Pharmaxi has entered into a working arrangement with the State Expert Center and the Ministry of Health of Ukraine, to create new legislation regulating low-interventional studies.
Pharmaxi experts are also involved in consulting activities for governmental departments linked to the development of eHealth services in the frame of the country. These two activities provide independent evidence for our deep expertise in clinical trials, as well as the development of specific electronic services.
Pharmaxi has a proven track record in the full range of clinical trial management services. Pharmaxi will provide a unique and significant contribution to your projects, developing from our experience in:
- Managing multi-site and multi-country trials
- Developing sophisticated Data Management services and procedures in strict accordance with GCDMP guidelines
- Understanding the research landscape in retrospective, case-controlled data collection, as well as large-scale non-interventional studies and multinational disease registries
- Meeting project timelines
There are advantages of clinical trials in Ukraine, as our local healthcare system is centralized. A significant benefit of centralization is recruitment in all therapeutic areas. The approval process is also easier and faster than what may be possible in other countries within the EU. Our doctors and other healthcare professionals are well trained to offer excellent clinical practice and high-quality data.
Table 1. Pharmaxi Essential Projects
|Investigated Disease||No. Pts||No. Sites|
|Hepatitis C (Ukraine, Latvia, Lithuania, Estonia)||1,450||18|
|Non alcoholic fatty liver disease (Ukraine)||1100||50|
|Pancreatitis (Poland, Khazakhstan)||220||16|
|Juvenile Rheumatoid Arthritis (Ukraine, Belarus)||450||32|
|Acute Pyelonephritis (Ukraine, Belarus, Romania, Bulgaria, Russia, Croatia)||416||28|
While looking forward to hearing from you, we welcome any questions you may have — so please do not hesitate to contact us for further details. We are available to provide any additional information as per your request.