Outsourcing of study coordinators
Training of the site’s personnel on study documents (protocol, pharmacy manual, laboratory manual, etc.), translation into Polish
eCRF/CRF completion
Creating source documentation templates (worksheets) for a given protocol/patient visit
Oversight of SAE and AE reporting
“Investigator Site File” maintenance
Site preparation for the selection, initiation, monitoring and close-out visit
Assisting the Clinical Research Associate during site visits
Resolving „issues” and „queries”
Coordination of patient reimbursement
Creating Standard Operating Procedures (SOP)
Training on introduction to clinical trials and GCP
Support in obtaining GCP and IATA certificates or in other training required by a given study
Staff support in creating CVs in Polish and English in accordance with the Sponsor’s requirements
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