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.
If you want to know more
or request a demo
You wish to receive the AD Quality flyer:
This information is intended for ALCOAM BY DESIGN exclusively for the day-to-day management of its customers and prospects. For more details on the protection of personal data collected from our website, please consult the legal notice.
You wish to request a presentation: