Pharmaxi LLC is a client-oriented, flexible, innovative and cost-attractive Contract Research Organization. We are focused on the clinical trials of medicinal products, medical devices, and dietary supplements. Pharmaxi performs services in Poland and Eastern Europe. We understand that there are no two identical projects; thus, our core procedures are governed by the set of project documents which keep and track all project-specific elements of the clinical trial.
What do we focus on?
Pharmaxi LLC conducts II-IV phase clinical trials and late-phase large-scale non-interventional studies. Besides this, the company is skilled in all trial activities: from study design negotiation to the creation of the final study report. You can rely on us even if you have a specific task which is not covered by our in-house facilities (drug depot, logistics, insurance, and delivery services). These activities are delegated to trusted and fully-vetted subcontracted companies.
Pharmaxi focuses on late-phase clinical trials for medicinal products, medical devices, and food supplements. We cover all types of activities: from trial design work-out to the statistics and final study report preparation. Our activities usually cover Eastern Europe countries. When there are wider geographical coverage needs, we manage them via our network of trusted partners.
We set up, configure and support the electronic data collection system for clinical trials - OnlineCRF. This system exists in three versions: 1) For clinical trials conduct, 2) Postmarketing and observational studies, and 3) Product and disease registries. OnlineCRF has been developed in accordance with 21CFR Part11 standards and our data management team performs per-project configuration and validation according to GCDMP industry standards. Systems can be managed within a study by our team or can be leased. If sites and data monitoring is executed by your staff, the Pharmaxi team plays a role in second-line support.
Pharmaxi has a deep background in the design and management of all types of non-interventional studies. Our dedicated team is well trained to understand the specificities of observational, epidemiologic, PASS and PAES studies. We have successfully managed several large-scale non-interventional studies (5000 patients, 100 sites) and developed reliable standard operating procedures to be an efficient and trustworthy partner.
Our data management department is actively engaged in the early stages of data management procedures. Before the study initiation, we prepare a statistical analysis plan and prepare the audit of the main documents. Before the data collection starts, we perform the protocol audit, CRF, diaries and other critical data sources to identify possible inconsistencies. Sometimes, we identify findings which can lead to a lack of important data during data collection. Data managers execute tasks on CRF annotation, data entry, data cleaning, data validation. Our SAS programmers and biostatisticians perform statistical analysis and provide you with statistical tables, results, and conclusions.
"Pharmaxi maintains the high professional level of personnel and clear processes aimed at goals achievement. We recommend Pharmaxi 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."
"We’ve been working with Pharmaxi in the frame of big multicentre study in Poland and Eastern Europe 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 experise and quality in the design and management of clinical databases."