The pillars of quality in clinical research centers are data integrity and human subject protection. Clinical Quality Assurance serves both as the typical auditor and independent role, but also as the compliance advisor and partner to the clinical team. Good Clinical Practice (GCP) regulations have no requirement for a QA department which makes the role of CQA a more flexible one.

In this presentation, we will explore the role of the Clinical QA professional in ensuring that all activities are done to ensure the data integrity of the trial data and the rights, welfare, and safety of trial participants.

Essex Industries Factory Tour

Sometimes, the hardest part is documenting policies and procedures. In this presentation – we will cover how we’ve implemented the latest innovations in generative AI to help anyone document any policy or procedure.

In addition – we’ll cover controlling such assets, measuring engagement to see which ones are more popular (which is unknown today) to prove ROI from documentation efforts, and how “crowdsourced” feedback would work to improve a process from feedback in the field. Towards the end – we’ll also cover techniques to ease change management for actually executing and tracking processes in real-time, as opposed to just publishing processes and hoping somebody looks at them!