Honor the gift of your clinical trial subjects and protect your clinical trial by assuring systems operate as intended.
We don’t just look at validation packages.
- The integrity of the clinical trial data created, modified, maintained, archived, retrieved, or transmitted by the system
- Business processes supported by the system
- How the system is operating in your business environment
What do you get? The information you need to answer three questions
- Have we honored our clinical trial subjects’ gift of participation?
- Did following the procedures result in a system that operates as intended and meets applicable regulatory requirements?
- Is the system, as currently used, operating as intended and meeting applicable regulatory requirements?
You may not be in a contractual position to have access to all the information required to conduct a full data integrity audit. In this case, we can help assess the adequacy of processes related to computer system validation, system use, and data review along with validation deliverables to help you decide if the vendor will be a good business partner.