OUR SERVICES
Auditing
Our services encompass a comprehensive approach to Investigator and Study Site audits

This includes:

  • Compliance Assessment: Ensuring adherence to applicable Good Clinical Practice (GCP) standards, national regulations, and GDPR regulations.
  • Site Tour and Documentation Check: Conducting thorough site inspections and assessing the availability and validity of essential documents, including SOPs, the protocol, informed consent forms, CRFs, and source documents.
  • Document Archiving: Verifying the proper archiving of critical documents.
  • Personnel Evaluation: Assessing the training and experience of study personnel and evaluating the workload of the study team.
  • Source Data Access and Verification: Confirming the accuracy and completeness of source data.
  • Investigational Product (IP) Handling: Ensuring proper storage, handling, and accountability of investigational products.

Our meticulous audit process is designed to maintain the highest standards of quality and compliance throughout the clinical trial lifecycle.

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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