Auditing - VALOS | Statistical solutionsfor your clinical trial

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Auditing

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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

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