The Clinical Research Department develops clinical research within the Healthcare Poland Foundation as part of the healthcare system — a source of patient access to innovative therapies, workforce development and revenue for healthcare providers. It operates under Regulation (EU) No 536/2014, the Polish Act of 9 March 2023 on clinical trials of medicinal products for human use and Good Clinical Practice (ICH GCP).
Leadership and team
- Klaudiusz Gajewski — Director of the Clinical Research Department
- Piotr Welenc — team member (quality and audit)
- Ewelina Bogiel — team member (legal and compliance)
Competencies
- assessment of the organisational, staffing and infrastructure readiness of clinical trial sites
- regulatory requirements for clinical trials of medicinal products and clinical investigations of medical devices
- agreement models between sponsor, CRO and site, and trial budgeting
- quality systems in clinical research and preparation for inspections and audits
- cooperation with the biotech, pharmaceutical and MedTech sectors
Tasks
- developing a standard agreement for clinical trial sites — a development direction and subject of stakeholder dialogue
- developing the concept of a virtual clinical trial site
- supporting hospitals in building research capacity
- connecting sponsors and CROs with sites in Poland
- disseminating knowledge on clinical research among staff and patients
Process scope
- Site readiness assessment — diagnosis of resources, processes and documentation
- Agreement standardisation — templates and negotiation principles for research agreements
- Feasibility — support in assessing trial feasibility and patient recruitment
- Research quality — SOPs, GCP training, preparation for monitoring and inspections
- Partnerships — cooperation with sponsors, CROs and academic centres
Procedures
- Registration of a site or sponsor and definition of the scope of cooperation.
- Site readiness assessment using the Department’s checklist.
- Corrective action plan: staff, SOPs, infrastructure, agreements.
- Implementation support and training of research teams.
- Review of results and transfer of conclusions to the Foundation’s self-learning loop.
Links within the Foundation system
The Department works with the Centre for Quality, Audit and Certification, the Legal and Compliance Department, the Medical Care Department and the Innovation Department.
Contact
Write to: klaudiusz.gajewski@healthcarepoland.pl · global@healthcarepoland.pl
All departments: Medical Care and HCPL Academy · Clinical Research · Quality, Audit and Certification · Innovation · Cross-Border Medicine · Security and Civil Defence · Health System · Operational Excellence · Legal and Compliance
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