Auditing

We do regularly perform process and system audits in Biostatistics, Data Management, and R&D IT with different objectives. This includes audits of our customers, service providers, and vendors of our customers.

Thanks to our detailed understanding of best practice in Biostatistics, we typically have identified several major or critical issues that needed resolution.

Customers have said that our audits were vital for getting well through a regulatory inspection.

Recommendations:

(1) audits should be executed regularly, at least every two years. This applies for your own processes as well as for processes at your providers.

(2) it is essential to properly follow-up on audits, and to resolve the issues identified.