The AD Quality service

De-risk your clinical trials: before thinking RBM*, think QbD*!

Develop a culture of GCP risks prevention within your clinical development, with an approach driven by the factors critical to the quality of your clinical trials.

We deliver a unified Risk Based Quality Management (RBQM) approach integrating Quality by Design and risk adapted monitoring, composed of:

A methodology based on the state of the art, that fully meets the requirements from ICH E6 (R2) and ICH E8 (R1) as they relate to quality risk management;

An application meant to avoid the overwhelming effect for the teams who have to carry out risk analysis for clinical trials whose operational complexity is most often high;

A structured, thus reusable, knowledge base.

*RBM=Risk Based Monitoring; QbD=Quality by Design

Specificity of AD Quality

A service meant to simplify the Risk Based Quality Management process implementation.
An e-Learning curriculum facilitating the acquisition of know-how, by delivering short training modules right on time before starting each new phase in the study.
An application delivering the Risk Management Plan and Report content to feed the study eTMF.

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