Pharmaxi has been providing high-quality clinical research services to sponsors for more than five years. Our history spans successful program management and support to biotech, pharmaceutical and medical device companies across all Phases (I-IV), services and geographic locations (North America, Central Europe and CIS Countries). We have successfully performed over 20 studies in 10 countries. Pharmaxi has provided integrated key clinical research services for these projects that included 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 trusted, quality providers to cover wide range of services (drug depot, logistics, insurance). Pharmaxi has also developed and validated EDC system in order to enhance the efficiency of clinical trials, observational studies and disease registries.
In addition, the principals of Pharmaxi have 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, side by side with the State Expert Center and the Ministry of Health of Ukraine, in order to create new legislation basis regulating low-interventional studies.
Pharmaxi experts are also involved in the consulting activity for government departments linked to the development of eHealth services in the frame of the country. These two activities provide the independent evidence of our deep expertise in clinical trials, as well as the development of very 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 as a result of our experience in:
There are strong advantages of clinical trials in Ukraine, as our local healthcare system is centralized. A large benefit of centralization involves recruitment in all therapeutic areas. Additionally, the approval process is easier and faster, than what may be possible in other countries within the EU. Our doctors and other healthcare professionals are well trained, so as 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 per your request.