PL

Departament of Academic CRO

StartDepartament of Academic CRO
Our TeamMRA-Funded StudiesOpen Calls and AnnouncementsSupporting structures: Early Phase Clinical Research Center
Project MCWBKCareerContact
Medical Research Agency: project calls and activity plansFor the patientsLead Your First Clinical Trial Before 40
Departament of Academic CROEarly Phase Clinical Trials Centre (EPCTC)Medical Research Agency

Academic CRO Services for Clinical Trials

We provide comprehensive CRO services for clinical trial sponsors – both non-commercial and commercial. Our team offers full support at every stage of study conduct, from documentation preparation and regulatory submissions to study oversight, monitoring and final analyses.

01 Clinical Trial Documentation

development of start-up timelines and risk management plans
review of documentation for compliance with Polish and international regulations
preparation of Clinical Trial Applications (CTA)
registration and submission support (CTIS)
preparation of patient-facing documents (PI, ICF and supporting materials)
documentation for Ethics Committees and the Polish Medicines Agency (URPL)
correspondence with regulatory authorities and Ethics Committees
annual and final clinical trial reports
Investigator Site File (ISF) management

02 Study Site Coordination

site feasibility assessments and feasibility studies
preparation of agreement templates (sponsor–investigator–site)
budget negotiations and contract support
coordination of communication between research teams and administration

03 Study Oversight and Monitoring

training of research teams (GCP and study procedures)
monitoring visits and reporting
verification of protocol compliance
data verification (CRF versus source documentation)
oversight of adverse event reporting
Trial Master File (TMF) management

04 Investigational Medicinal Product (IMP) Management

development of IMP labelling in compliance with GMP requirements
oversight of IMP documentation and logistics
control of storage and transport conditions
quality procedures and deviation reporting
participation in audits and inspections

05 Pharmacovigilance (PV)

pharmacovigilance activities and safety oversight
development of PV SOPs and procedures
SAE/SUSAR reporting and EudraVigilance submissions
safety reporting and communication with regulatory authorities

06 Statistical Support

support in clinical trial design and methodology
database preparation and statistical analysis plans
eCRF validation
analyses for interim and final study reports