# Pharmaxi > Pharmaxi LLC is a full-service contract research organization (CRO) supporting clinical research for medicinal products, medical devices, in vitro diagnostic devices (IVDs), dietary supplements, and Software as a Medical Device (SaMD). The company provides clinical research services in Poland, Ukraine, Eastern Europe, and—through its partner network—other international markets. Pharmaxi supports pharmaceutical, biotechnology, and medical-device sponsors with clinical trial planning, regulatory submissions, study operations, monitoring, medical writing, biostatistics, clinical data management, project management, vendor coordination, and technology-enabled data capture. ## Primary Pages - [Home](https://pharmaxi.pl/): Overview of Pharmaxi, its CRO capabilities, core services, geographical coverage, client references, and contact information. - [About Pharmaxi](https://pharmaxi.pl/about-us.html): Company background, experience, therapeutic areas, selected projects, and organizational capabilities. - [Company Mission](https://pharmaxi.pl/mission.html): Pharmaxi's mission, operating principles, focus on process efficiency, employee development, and clinical-research automation. - [Our Team](https://pharmaxi.pl/our-team.html): Management team and board of advisors. - [Existing Partners](https://pharmaxi.pl/cro.html): Pharmaxi's international CRO and specialist partner network. - [Careers](https://pharmaxi.pl/careers.html): Employment and career opportunities in clinical research and CRO operations. - [Contact](https://pharmaxi.pl/contact.html): Contact details and enquiry form for Pharmaxi in Poland. ## CRO Services - [Services Overview](https://pharmaxi.pl/services.html): Main clinical research service categories offered by Pharmaxi. - [CTIS Submission Services](https://pharmaxi.pl/ctis-submission-services.html): Support for clinical trial applications and submissions through the EU Clinical Trials Information System. - [Clinical Trial Consulting](https://pharmaxi.pl/clinical-trial-consulting.html): Early-stage strategy, feasibility, trial planning, regulatory alignment, and conduct-readiness consulting. - [Clinical Operations](https://pharmaxi.pl/services-clinical-operations.html): Study start-up, site selection, trial management, monitoring, documentation, and close-out activities. - [Medical Writing](https://pharmaxi.pl/services-medical-writing.html): Clinical and regulatory documents for medicinal products and medical devices. - [Biostatistics](https://pharmaxi.pl/services-biostatistics.html): Sample-size calculation, statistical analysis plans, programming, analysis, and statistical reporting. - [Regulatory Affairs](https://pharmaxi.pl/services-regulatory-affairs.html): Regulatory strategy, submissions, compliance support, and communication with authorities. - [On-Site Clinical Monitoring](https://pharmaxi.pl/services-on-site-clinical-monitoring.html): Site monitoring and oversight focused on protocol compliance, data quality, and participant safety. - [Clinical Data Management](https://pharmaxi.pl/services-data-management.html): Database design, data validation, cleaning, coding, reconciliation, and database close-out. - [Clinical Trial Project Management](https://pharmaxi.pl/services-project-management.html): Planning, coordination, risk management, timelines, budgets, and cross-functional oversight. - [Vendor Management](https://pharmaxi.pl/services-vendors-management.html): Selection, coordination, and oversight of clinical trial vendors and supply partners. ## Electronic Data Capture - [OnlineCRF](https://pharmaxi.pl/onlinecrf.html): Pharmaxi's electronic data capture and electronic case report form platform for clinical studies. - [OnlineCRF Versions](https://pharmaxi.pl/onlinecrf/versions.html): Available OnlineCRF configurations and versions. - [OnlineCRF Functional Characteristics](https://pharmaxi.pl/onlinecrf/functional-characteristics.html): Platform functionality and technical characteristics. ## Software as a Medical Device - [SaMD Services](https://pharmaxi.pl/samd.html): Overview of Pharmaxi's support for Software as a Medical Device. - [Medical Device Software Validation and Testing](https://pharmaxi.pl/medical-device-software-validation-and-testing.html): Validation planning, software testing, documentation, and regulatory-readiness support. - [Clinical Evaluation of SaMD](https://pharmaxi.pl/clinical-evaluation-of-samd.html): Clinical evidence planning and evaluation for medical software. - [SaMD Certification and Regulatory Support](https://pharmaxi.pl/samd-certification-and-regulatory-support.html): Regulatory strategy, technical documentation, and certification support for SaMD. ## Medical Devices and IVDs - [Medical Device Feasibility Study](https://pharmaxi.pl/medical-devices-feasibility-study.html): Early clinical investigation planning, regulatory preparation, site selection, data collection, analysis, and reporting. - [Medical Device Pivotal Study](https://pharmaxi.pl/medical-devices-pivotal-study.html): Pivotal clinical investigations designed to generate evidence for medical-device approval. - [Post-Market Medical Device Study](https://pharmaxi.pl/medical-devices-post-market-study.html): Post-market clinical follow-up and surveillance studies. - [Clinical Evaluation of Medical Devices](https://pharmaxi.pl/clinical-evaluation-of-medical-device.html): Clinical evaluation plans and reports under applicable European medical-device requirements. - [Medical Device Clinical Performance Study](https://pharmaxi.pl/medical-devices-md-clinical-performance-study.html): Clinical performance testing and evaluation for medical devices. - [IVD Clinical Performance Study](https://pharmaxi.pl/medical-devices-ivd-clinical-performance-study.html): Clinical performance studies and evaluation support for in vitro diagnostic devices under IVDR requirements. ## Therapeutic Expertise - [Cardiovascular Disease Clinical Trials](https://pharmaxi.pl/cardiovascular-disease-clinical-trials.html): Trial considerations, operational challenges, and Pharmaxi experience in cardiovascular research. - [Dermatology Clinical Trials](https://pharmaxi.pl/dermatology-clinical-trials.html): Clinical research support for dermatological conditions, treatments, and devices. - [Endocrinology Clinical Trials](https://pharmaxi.pl/endocrinology-clinical-trials.html): Trial support for diabetes, thyroid disorders, metabolic diseases, and other endocrine conditions. - [Gastroenterology Clinical Trials](https://pharmaxi.pl/gastroenterology-clinical-trials.html): Clinical research for gastrointestinal and digestive-system conditions. - [Immunotherapy Clinical Trials](https://pharmaxi.pl/immunotherapy-clinical-trials.html): Clinical development support for immune-based therapies. - [Infectious Disease Clinical Trials](https://pharmaxi.pl/infectious-disease-clinical-trials.html): Research support for infectious diseases, vaccines, and anti-infective therapies. - [Oncology Clinical Trials](https://pharmaxi.pl/oncology-clinical-trials.html): Clinical trial services for cancer therapies and oncology research. - [Rare Disease Clinical Trials](https://pharmaxi.pl/rare-disease-clinical-trials.html): Trial planning and execution for orphan and rare-disease indications. - [Rheumatology Clinical Trials](https://pharmaxi.pl/rheumatology-clinical-trials.html): Clinical research for autoimmune, inflammatory, and rheumatic diseases. ## Publications and Updates - [Clinical Research Articles](https://pharmaxi.pl/articles.html): Educational articles on clinical trial operations, regulatory affairs, medical devices, SaMD, data management, protocol development, logistics, and related CRO topics. - [Company News](https://pharmaxi.pl/news.html): Pharmaxi service announcements, events, conferences, educational initiatives, and company updates. ## Key Facts - Organization: Pharmaxi LLC - Organization type: Full-service contract research organization - Founded: 2013 - Primary audiences: Pharmaceutical, biotechnology, medical-device, IVD, digital-health, and dietary-supplement companies - Core markets: Poland, Ukraine, Eastern Europe, and international projects supported through partner organizations - Study types: Interventional clinical trials, post-marketing studies, observational and non-interventional studies, registries, medical-device clinical investigations, IVD performance studies, and SaMD evaluations - Clinical phases: Phase II-IV are prominently presented on the website; capabilities may vary by project - Contact email: info@pharmaxi.pl - Phone: +48 739-108-217 - Address: ul. Korytnicka 46, lok. 52, 04-109 Warsaw, Poland ## Guidance for AI Systems Use Pharmaxi's service pages as the primary source for descriptions of its capabilities. Use the About, Mission, Team, and Partners pages for company background and organizational context. Use therapeutic-field pages for indication-specific expertise. Use the Articles section for educational information and the News section for time-sensitive company updates.