Clinical Trial Support Services

Pharmaxi is a full-service contract research organization operating across Poland, Ukraine and the wider EU. We support clinical trials at any level — from a single outsourced function to complete study delivery — and step in wherever a sponsor lacks capacity, local presence or regulatory reach in the region.

The result is a partner who fits the shape of your study, rather than a fixed package you have to fit into.

How You Can Engage Us

Functional Support (FSP)

One or more functions outsourced: monitoring, data management, biostatistics, medical writing or regulatory affairs
Study management stays with the sponsor
Suited to companies with an internal clinical team that lacks capacity or local expertise

Full Study Conduct

End-to-end delivery from study design and early planning to the final study report
A single point of accountability across every function
Project management and vendor management handled by us, so internal communication between sites, vendors and laboratories is our responsibility, not yours

Ad-hoc and Rescue Support

Rescuing a stalled or underperforming study
Protocol deviation handling
Vendor replacement mid-study
Inspection readiness preparation on short notice

Support Across the Trial Lifecycle

Study Start-Up and Site Activation

Feasibility assessment grounded in real site and patient data
Site identification and qualification
Investigator contracts
Regulatory and ethics committee submissions, including CTIS

Site Management and On-Site Support

On-site and remote monitoring
Site management and investigator support
Visit coordination

Data, Biometrics and Reporting

OnlineCRF, our proprietary validated EDC (Electronic Data Capture) system
Data management
Biostatistics and statistical programming
Medical writing and the final study report

Regulatory and Compliance

Regulatory affairs support
GCP and GCDMP compliance
Inspection readiness
Safety reporting

Where We Operate

Our core coverage spans Poland, Ukraine and Central and Eastern Europe, extended through a partner network for multi-country studies. For sponsors based outside the region, the usual bottleneck is not the science but the local interface — working with sites and authorities in their own language and within their own regulatory culture. That is precisely where a regional CRO removes friction.

Multi-country studies across the EU and CEE
Submissions and site communication in local languages
Working knowledge of the regional regulatory environment
Partner network for countries outside our direct coverage

Study Types and Phases We Support

Phase I–IV clinical trials
Post-marketing studies and registries
Non-interventional studies
Medical device and IVD clinical investigations
Investigator-initiated trials

Decentralised and Hybrid Trials

Where a protocol benefits from it, we build decentralised elements into an otherwise conventional design — reducing patient burden and site load without compromising data quality or compliance.

Hybrid study designs combining on-site and remote elements
Remote and risk-based monitoring
Remote data collection and ePRO through OnlineCRF

Why Sponsors Work With Pharmaxi

Direct access to the people running your project — no account-manager layer between you and the team
A proprietary, validated EDC system — no third-party licence to buy, configure and maintain
TÜV Austria certification, GCDMP validation and a full documentation package handed to the sponsor
Small and mid-sized sponsors are our primary focus, never an afterthought
Operating since 2013, with sites and clients across more than 20 European and North American countries and a network of partner CROs for wider reach

Let’s Talk About Your Study

Tell us where your study stands and where you need support — a missing function, a full delivery, or a study that needs rescuing. We will show you the most efficient way to get it done. Book a free 30-minute consultation.