Clinical trials conduct - Pharmaxi

Pharmaxi is one of the leading mid-size Contract Research Organization in Ukraine. Thanking a large population and centralised system of health care Ukraine is an attractive location for the clinical trials conduct. An experienced clinical community trained in Good Clinical Practices produces high-quality data and the higher recruitment rates than in other EU countries. Such a favourable conditions lead to the development of strong CRO community in the country and give us permanent stimuli to be an effective, client-oriented, flexible, innovative and cost-attractive company.

The main focus of Pharmaxi is a conducting of II-IV phase clinical trials and late-phase large-scale non-interventional studies. The range of services embraces all types of activities from the study design negotiation to the final study report creation. If some specific tasks are not covered by in-house facilities (drug depot, logistics, insurance) we subcontract trusted and fully-vetted local vendors.

In rare cases, we develop the unique services (including SOPs and working instructions) by demand. So, let’s contact us to make sure that clinical trial services can be qualitative, coordinated, conformed and not very expensive.

OnlineCRF Pharmaxi’s Electronic Data Capture (EDC) system has developed to manage Phase III and Phase IV clinical studies. OnlineCRF is a module-based solution that can be rapidly configured in strict accordance with protocol demands. There are three editions of OnlineCRF that is developed for 1) Clinical trials, 2) Observational studies and 3) Registries. Each type of the study implies particular features. Thus, specific OnlineCRF edition fits to the correspondent project in terms of configuring and monitoring. Study Designer is a module that is used to configure the right pathway for the patient treatment. If patient goes through the multiple stages (for example: inclusion/exclusion criteria - screening - period of preparation - randomisation - treatment - follow up) the structure of visits can be managed by OnlineCRF Study Designer in a short period of time.
Site Management Pharmaxi identifies the best investigational sites for the Study and provides the management and the necessary support. A Feasibility takes into account the folowing: therapeutic area, requirements to investigators and sites, technical equipment and other important elements. Qualification Visits, SDV and Closeout Visits carry out on-site by qualified personnel. Training of investigators, data collection progress and Data cleaning executed remotely with EDC system OnlineCRF which makes the project transparent and well-driven. CRAs and CTLs can control the activity of patients enrollment, the number of completed/incompleted CRFs, the number of the CRF editing and the reason for the edition. Each type of users can oversee the different project indicators. Project Manager can view the overall study progress and CRA activity. CRAs have access to the activity of the subordinate investigators only.
Clinical Trial Management Clinical operation and administrative team takes care of the local Ethics and Regulatory Submissions, provides support in Contracts management, maintains Trial Master File and essential documentation during the project.
Medical Writing We can assist you in all the documentats preparation e.g. Standard Operating Procedures, Clinical Study or Pharmacovigilance Reports, Study Protocol, Investigator Brochure, Informed Consent Form or Case Report Form.

Sanofi:

"Pharmaxi LLC maintains the high professional level of personnel and clear processes aimed at goals achievement. We recognize Pharmaxi LLC as a trustworthy partner with a responsible attitude to their obligations and consider them to be a team of experts in the profile activity. We recommend Pharmaxi LLC as a reliable and stable business partner."

Alla Gontar, Medical Head

AbbVie:

"We’ve been working with Pharmaxi since 2014 in frame of epidemiological multicentre study in Ukraine and the Baltic countries in the field of hepatitis C. We are satisfied with the work of the team that demonstrates the high level of professionalism and quality in the design and management of clinical databases."

Galyna Bryn, Ukraine & CIS Medical Director