You may be confused as to how should data integrity and data quality be defined, so, let us look at some definitions first. According to the “Clinical Trials Transformation Initiative” (CTTI), quality in clinical trials is defined as “the absence of errors that...lire plus
You could ask a similar question regarding your car: “what objective evidence makes you confident that your car can drive you safely to your destination?” The answer is three-fold. The first objective evidence that makes you confident about the safety of your car, is...lire plus
Second objective evidence: unless your car is a very old one, you know that you can rely on its electronic system to activate a visual alarm and a sound as soon as it detects an event that can represent a risk. The visual sign may be intuitive enough to easily and quickly decide which action should be taken to correct the issue. Alternatively, you could also refer to the car leaflet where the action to be taken is explained next to each control panel warning light. The alarm resumes as soon as the issue is corrected…lire plus
The third objective evidence that makes you confident that your car can drive you safely to your destination, results from the maintenance that you are delegating to your car dealer according to a predefined schedule.Your car dealer, hopefully a good professional, uses a control check list, specific to the model of your car, in order to perform the regular maintenance operations. ..lire plus
« We are committed to deliver the objective evidences that you need, in order to ensure that a proper level of control is maintained over the integrity of your clinical study data. We work collaboratively with you and all the parties involved to achieve this goal. »
Our value added derives from the following approaches, and is meant to enable compliance with ICH E6 Addendum R2…lire plus
RBM: should top management care about it? What should they expect from it?
Risk Based Monitoring (RBM) and Risk Based Quality Management (RBQM) are methods that have been encouraged by the EMA and the FDA since 2013. A risk based approach to quality management in clinical trials is now fully enshrined in ICH GCP E6 (Addendum R2, just approved)…lire plus