Clinical Trial Services

Audit Services

At CCA we offer a wide range of professional and comprehensive audit services. Among others we carry out:

• Investigator site audits
  CCA monitors review the in-house as well as on site documentation to assure compliance with ICH GCP and all applicable regulations
• Phase I audits
  We perform full facility audits of Phase I units to ensure compliance with the appropriate guidelines and regulations prior to placement of study. We also provide live phase audits to assess all protocol requirements are followed
• Preparation for Regulatory Inspections
  Full mock inspections can be carried out or advice and training of staff provided with the view of regulatory authorities carrying out inspections in accordance with the Clinical Trial Directive 2001/20/EC.
• Database Audits
  Our experienced monitors can perform database check to provide assurance that all data procedures have been carried out and that the database is a true reflection of data captured on CRFs.
• Clinical Report Audits
  These are performed in order to provide assurance that the clinical study report accurately reflects the conduct and results of the study and that the format complies with ICH GCP.
• Training
  At CCA we offer individually designed courses to update clinical research personnel on GCP requirements. We also train potential new auditors in auditing skills.
• Preparation of Standard Operating Procedures
  CCA provides advice and preparation of SOPs in compliance with GCP requirements.