Smooth Drug Development devotes its special attention to compliance with study conduct requirements and to quality of obtained data. Our company has implemented and been following the international standard ISO 9001 "Quality management systems. Requirements".
A quality audit is an integral part of clinical research, especially when its results are submitted to drug registration applications to official regulatory bodies.
Our company conducts internal quality audits of studies on a regular basis, as well as provides contracted services on independent audits.
In accordance with the term in ICH GCP, an audit is "a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures, Good Clinical Practice (GCP), and the applicable regulatory requirement(s)".
An audit includes preparation, inspection and reporting. During the check, an auditor checks Sponsor file, interviews Sponsor and CRO teams, and performs visits to one or several clinical sites.
During site audit the auditor performs the following activities:
- Interview with the study team to evaluate their understanding of the protocol and GCP
- Review availability of the required study approvals
- Review availability of the required ethics committee documentation
- Review informed consent obtaining procedure
- Review of data in CRFs against data in source documentation
- Review of safety reporting
- Review of protocol deviation registration
- Review of procedures on investigational product handling
- Review of procedures on biological samples handling
- Check of site laboratory
- Check of site equipment used in the study
- Check of correspondence flow with the site
- Check of investigator file maintenance quality
- Assessment of CRA work
- Closing meeting with the study team to discuss results
Based on audit results, the auditor prepares a report and corrective and preventive action plan (CAPA). Upon successful accomplishment of the planned actions, the auditor issues an audit certification.
Smooth Drug Development provides full spectrum of clinical research services in Russia, CIS and Baltic states since 2011.