Quality management is an important part of the Veracity Logic philosophy. Our IRT platform is compliant with 21CFRPart11 and EU Annex 11 regulatory guidances…as well as with international industry standards for good clinical practice and software development. Internal audits conducted semi-annually by senior management, and routine gap analyses by external reviewers help maintain our high quality performance.
The Problem: On the one hand we’ve got statistics. On the other hand, we’ve got human lives. Because of the latter, our hearts tend to have zero tolerance for errors in clinical trial data. How do we find the right level of risk and quality control (QC)? Let’s tempt the +
Problem: Tom Smith, a Study Coordinator at Site A in your clinical study, retired from the project three months ago. Due to a communication snafu, your clinical staff forgot to remove Tom’s name from the roster of active system users of the project’s IRT system. Two months later, your company’s QA +
Challenge Your study has been suffering from slow enrollment. An excellent candidate, medically speaking, walks into Site 101 but there’s one problem: The minimum enrollment age for the clinical trial is 18. The age of the new potential candidate is 17 years, eight months. The Study Coordinator at the Site not +