The Clinical Trials Department (DBK) of Healthcare Poland Foundation acts as a neutral collaboration platform for the clinical research market in Poland — between sites, sponsors, CROs, investigators and public institutions. Our aim is for more trials to come to Polish hospitals and to start there faster.
Strategic partner: Polish Hospital Federation (PFSz).
Why this department
The most serious bottleneck for commercial clinical trials in Poland today is neither science nor patient access, but signing the site agreement. Sponsors plan to activate a site within a few months, while negotiations in large hospitals can take years. Every hospital negotiates on its own, and the same issues return in every contract: data protection, governing law, liability, payments.
The second bottleneck is fragmented IT systems — a sponsor re-validates the system at every new site. The third is that administrative support (around 35 clinical trial support centres) mainly covers large institutions, while medium and small hospitals remain without back office, even though they have patients and investigators.
Two lines of work
Line A — Trial Intelligence
Data and verifiability: monitoring of European trial registers (EU CTIS), mapping of activity in Poland, feasibility and site-selection data, grant due diligence. We work only with public data, in line with GDPR.
Line B — Market Platform
Relationships and convergence: a clinical research market round table, working groups, recommendations that simplify procedures, visibility of Polish sites at home and abroad.
Line A provides evidence, Line B provides reach. We come to the market with data, not opinions.
Direction of development — the department strategy
The strategy prepared by the Head of Department rests on one principle: what we can improve with our own competence and cooperation — let us improve. It identifies four areas of shared solutions:
- Contracts and processes — model contract clauses, recommended processes, implementation checklists, shorter startup timelines.
- Tools and software — shared IT solutions, reporting standards, feasibility support, communication between sites.
- Supply of medicinal products — logistics and availability of registered products used in trials.
- Market-driven initiatives — in particular those raised at the round table.
| Stage | Scope |
|---|---|
| 1. Relationships and diagnosis | Meetings with PFSz, the Medical Research Agency (ABM), INFARMA, GCPpl, investigators and research-active hospitals — a map of market problems. |
| 2. Platform launch | Round table, workshops and working groups: visibility, feasibility, contracts, startup timelines, medicinal products, software and interoperability. |
| 3. Positioning | A report on the clinical research market in Poland, publications, conference presence, European and international cooperation. |
Projects opening now
A standard clinical trial agreement for sites
Healthcare Poland, in partnership with the Polish Hospital Federation, takes on the role of a neutral third party: developing, together with the largest clinical trial sponsors, a model agreement that covers most typical contracts with Polish hospitals. The negotiable part — the study budget and rates — stays with the parties; the fixed part — data protection, compliance with Polish and EU law, liability, insurance, ownership of results — is agreed once, for everyone.
- Talks with leading sponsors on their key contract requirements.
- A round table with GCPpl, INFARMA and the Medical Research Agency — a joint standard initiative.
- A model agreement for Polish sites, made available to hospitals — including members of the Polish Hospital Federation.
- Contract validation and certification of sites that apply the standard, together with the Quality, Audit and Certification Center.
Goal: agreements signed in weeks, not years.
Virtual site — a virtual Clinical Trial Support Centre
Medium and small hospitals have patients and investigators but no back office for running trials. We are building a virtual support centre that remotely takes over administration: preparing and routing the agreement, coordination with the ethics committee and the sponsor, documentation and payments.
- One working standard and one team for many hospitals — no need to build structures in each of them.
- A shared interface to hospital systems based on Open HCPL HIS — open API, one vendor validation instead of validation at every site.
- Trials run inside the hospital, not outside it — revenue and knowledge stay in the public healthcare system.
- Development towards a network of trial-ready sites available to sponsors from Poland and abroad.
Project team
Klaudiusz Gajewski, MPharm
Head of the Clinical Trials Department
klaudiusz.gajewski@healthcarepoland.pl · LinkedIn
Leads both projects; dialogue with sponsors, CROs and sites; market round table.
Ewelina Bogiel
Head of Legal and Compliance
ewelina.bogiel@healthcarepoland.pl · LinkedIn
Legal design of the model agreement, compliance with Polish and EU law, data protection.
Piotr Welenc
Director, Quality, Audit and Certification Center
p.welenc@healthcarepoland.pl · LinkedIn
Contract validation, the virtual site working standard and certification of sites applying the standard.
Let us start the dialogue
We invite hospitals (especially PFSz members and sites without their own support centre), sponsors and CROs, investigators and industry organisations. Join the work on the standard agreement or express interest in joining the virtual site.
Write to the Head of DBKContact the Foundation
Principles
- Just Culture and due diligence — inconsistencies are flagged and reported, not hidden.
- Neutrality — as round-table host we keep an equal distance from all market participants.
- GDPR — health data only in pseudonymised form; we do not recruit patients or give medical advice.
Related: Project map · Innovation Center · Quality, Audit and Certification Center · Polish Hospital Federation
