OUR SERVICES
Auditing
- Assessing the compliance with the applicable standards of Good Clinical Practice (GCP), National Regulation, and GDPR regulation
- Tour of site, documentation’ check (availability, the validity of SOPs, protocol, ICF, CRF, source documents, etc.), archiving of documents
- Evaluation of Personnel, i.e. training and experience of the personnel, study team workload
- Source data access and verification
- Investigational Product (IP) handling, storage, and accountability
CRO Audits
Assessing the compliance with the applicable standards of Good Clinical Practice (GCP), National Regulation, and GDPR regulation
Tour of site, documentation’ check (availability, the validity of SOPs Quality Management System (QMS)), archiving of documents
Evaluation of Personnel, i.e. skills, training, and qualification
CAPA Management System
Laboratory audits according to GCLP
- Assessing the compliance with the applicable standards of Good Clinical Practice (GCP), National Regulation, and GDPR regulation
- Tour of site, documentation’ check (availability, validity of SOPs, protocol), archiving of documents
- Evaluation of Personnel, i.e. skills, training, and qualification
- Samples handling, trace, and archive
- Instruments maintenance, calibration, qualification
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