Blog

 

Have you updated your operations and procedures to meet ICH E6(R2)?

Are your IVRS configurations and customizations programmed correctly?

Are your electronic records Attributable? Legible? Original? Accurate? Complete?

Are your lab’s electronic records Attributable? Legible? Original? Accurate?

Are your data flow diagrams accurate, up-to-date, and complete?

Can your provider explain an image’s audit trail as it moves through their process?

How is your provider helping you maintain the integrity of your clinical data?

How is your provider helping you maintain the integrity of your ePRO data?

I live in Fabulous New York

but my clients are global in scope.