The Pope is infallible - we are not.

We are in a people business and people do make errors. As a matter of fact, the human element is the largest single source of error in all we do.

To keep this source of error from affecting the data generated in your clinical trial, prior to engaging in any project, we perform a Clinical Trial Feasibility Assessment, analysing our abilities, resources and weak points.

 

This process is very thorough.

This pre-contract analysis of the complete project course and necessary resources reveals possible weak points before we start a project and enables us to install proper error prevention and control mechanisms.

We exceed the requirements of GCP, where only error detection and reporting is required, but neither error correction nor error prevention are asked for. Both error correction and error prevention are an integral part of our ISO9001 Quality Management System.

We never rely on a routine. Through our preventive measures and effective Quality Control we can offer you the best combination of resources as well as an optimal planning and smooth running of your project.

 

Your personal benefits:

• We do not wait for errors to happen, we do everything to prevent them.

• We keep a continuous error log during the complete project course and make it a section of our master trial file for you to check - we do not try to hide anything from you.

• Every error (or non-conformity) leads to immediate corrective action and installation of preventive measures to avoid recurring.

• We always keep you updated on the course of your project by regular Clinical Trial Progress Reports, at least every 2 weeks and in addition at every milestone.

• We minimise your efforts for error detection, data queries and our efforts for data query resolution.

• Our quality level is extremely stable: once you have experienced the quality of one of our studies you can depend on the same quality level for all future projects.