Independent
audits

Cromos Pharma performs independent audits of sites and facilities followed by a formal detailed report with a comprehensive description of all findings noted. All activities are performed in accordance with appropriate SOPs and Working Instructions.

 

Our certified auditors perform a wide range of independent audits that include:

 

  • Clinical site GCP audits
  • Documentary Trial Master File audits
  • System Vendor Audits
  • Regulatory Inspection and Sponsor’s audit readiness check

Cromos Pharma Quality department provides consultancy services for Quality Management System development, implementation, and maintenance, including Quality Management System for investigational sites. All audits are followed by detailed reports including the description of findings and possible corrective and preventive actions.

Cromos Pharma has over 18 years of experience in managing all aspects of clinical trials across a range of therapeutic areas. With operations in the US, Central and Eastern Europe we combine global expertise with profound local market knowledge to deliver end to end solutions supporting our pharma and biotech clients.

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM