Vendor Qualification Audits –
Contract Research Organizations
We offer audits of Contract Research Organizations to support you to evaluate the compliance status and specific risks to address in the contracts, governance meetings, or studies.
We can perform a full service audit or audits tailored to specific services, e.g. data management, biostatistics, imaging, PK/PD analysis. In the audits we not only refer the applicable regulations, but also current standards such as the CDISC standards CDASH, SDTM and ADaM can be addressed.
Supplier Audits –
Software Providers and Data Centers
We offer audits of providers of electronic solutions used in clinical development, e.g. providers of Electronic Data Capture, Interactive Response Technology, electronic Patient Recording Outcome Systems, electronic Trial Master Files, Clinical Trial Management Systems, Imaging, Data Warehouse, Laboratory System Information Systems, and Pharmacovigilance Systems.
- Software as a Service providers
- Software Development Providers
- Data Centers
to assess compliance with regulatory requirements, e.g. 21 CFR Part 11, ICH E6 (R2), Annex 11.
Internal System Audits
If you need support with running your internal audit program or if you need an external organization to perform independent audit we can support you with our expertise and can facilitate your quality improvement initiatives.
In some cases you may not need an audit, but an assessment to prepare a project or a gap analysis to identify existing issues in your quality management system or validation framework, which need to be addressed. We offer our expertise to identify the gaps and advice on resolutions tailored to your company structure and processes.