Compliance, integrity of data and protection of subjects
As defined in ICH E6 5.19.1, the purpose of clinical audits is to evaluate the trial conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements.
It'sQA provides independent consultancy and pharmaceutical auditing in the area of Good Clinical Practice, providing assurance of compliance with ICH and applicable regulatory requirements (GCP Audit service). The European Clinical Trial Directive now mandates inspections by regulatory agencies. Let us help prepare you for such an eventuality by carrying out a 'mock' inspection of your organisation.
It'sQA auditors are qualified and experienced in conducting audits of all systems, processes and studies in clinical research - including the interfaces with GLP and GMP and the use of computer systems. Not being involved in any other clinical research activity enables It'sQA to conduct truly independent audits with no conflict of interest.
We have experience in most therapeutic areas and in all Phases I-V. We can help you develop and deliver a complete audit programme for clinical trials or simply help with particular aspects of GCP audits. We can use our auditing SOPs and systems or we can use clients' SOPs and systems to meet each individual client’s needs.
Common audits include:
- Investigator site audits
Review of both in-house and on-site documentation to assure compliance with ICH GCP and all appropriate regulations
- Phase I audits
Full facility audits of Phase I units to assure compliance with the appropriate guidelines and regulations prior to placement of study. Live phase audits to assess all protocol requirements are followed
- Preparation for Regulatory Inspections
Regulatory authorities carry out inspections in accordance with the Clinical Trial Directive 2001/20/EC and the local regulatory requirements. Full mock inspections can be carried out or advice and training of staff provided
- Database Audits
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
To provide assurance that the clinical study report accurately reports the conduct and results of the study and that the format complies with ICH GCP
- Clinical Laboratory Audits
Audits of central clinical laboratories to give assurance that they are working to Good Clinical Laboratory Practice standards
- Assessment audits of CROs and other Vendors
Independent audits of CROs prior to contract placement to give assurance that the organisation is fully compliant with ICH GCP and able to provide the service required. Re-qualification audits to ensure level of services is maintained
Global clinical audits
We have conducted clinical audits all over the world including: Belgium, Bulgaria, Canada, Croatia, Chile, Czech Republic, Denmark, France, Germany, Great Britain, Holland, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, USA, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Sweden, Turkey, Ukraine, China, Estonia, Netherlands, Australia, New Zealand, UK, Korea, Indonesia, Taiwan and Vietnam.