Ukrainian contract research organisation (CRO) offers services in I-IV phase clinical trials (site selection, project and site management, monitoring, the electronic case report form ((e)CRF) and database development, data management, biostatistics, pharmacovigilance, regulatory support and medical writing). The company seeks institutions, research centres, pharmaceutical and biotech companies who are interested in biologically-active substance and medical device investigation and development.
The company is privately held and headquartered in Kyiv, Ukraine. As a CRO, it has been providing high-quality clinical research services to sponsors for more than four years. The company carries out the 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). The firm 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. A separate branch of services specialises in late-phase clinical studies: pragmatic, observational, epidemiological, post-authorization are safety studies and registries. The company has also developed and validated electronic data capture system in order to enhance the efficiency of clinical trials, observational studies and disease registries. All services are conducted in strict compliance with International Council for Harmonisation guidelines and applicable European Union Directives. The main goal of the CRO is partnering with clinical laboratories, clinical centres and involves trusted providers to qualitatively cover a wide range of services through services agreement.
Innovations and advantages
There are strong advantages of clinical trials in Ukraine as company's local health care system is centralised. 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 EU. Doctors and other healthcare professionals are good clinical practice trained so as to offer excellent clinical practice and high-quality data. Trials in the early phase are conducting at specialised Food and Drug Administration and European Medicines Agency audited clinics with a live database of healthy volunteers. In-vitro and in-vivo studies are conducted at the premises of Good Laboratory Practice - certified laboratory. The main innovation is a developed, validated and successfully implemented Electronic Data Collection system "OnlineCRF". The system was created in strict accordance with Code of Federal Regulations 21 part 11 guideline. It validates and verifies according to Standard Operation Procedures which have been written in comply with Good Clinical Data Management Practices standard and certified (ISO 9001:2008). Web-based Electronic data capture system supports several user’s roles, predefined rules and can be deployed to collect clinical data from multiple countries and hundreds of investigational sites.
Current stage of development
Electronic Data Collection system is constantly developing. New modules and functions are gradually added to the system making it more convenient, user-friendly and more powerful in terms of project monitoring, data cleaning and automation of routine procedures.
01004001 Applications for Health
06001002 Clinical Research, Trials
06001012 Medical Research
06001015 Pharmaceutical Products / Drugs
06002007 In vitro Testing, Trials
Market application codes
04009 In vitro Testing, Trials
05007002 Pharmaceuticals/fine chemicals
Comments, number and date of patent
Electronic Data Collection system is an asset of the company and can be provided as a Software as a Service. Patent(s) applied for but not yet granted
Type of partner sought
The company seeks institutions, research centres, pharmaceutical and biotech companies who are interested in biologically-active substance and medical device investigation and development.