Investigator /
Study site 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, 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
We are very grateful for the collaborative efforts and the excellent work from Valos.
«Client since 2007»
