Blog
Are you inspection ready? Are your vendors?
May 2, 2017
Have you updated your operations and procedures to meet ICH E6(R2)?
April 28, 2017
Are your IVRS configurations and customizations programmed correctly?
Are your electronic records Attributable? Legible? Original? Accurate? Complete?
April 28, 2017
Are your lab’s electronic records Attributable? Legible? Original? Accurate?
Are your data flow diagrams accurate, up-to-date, and complete?
April 28, 2017
Can your provider explain an image’s audit trail as it moves through their process?
Can you demonstrate how the integrity of your clinical data is maintained? Are your audit trails secure and periodically reviewed?
April 28, 2017
How are your clinical teams managing access to investigator site data?
How is your provider helping you maintain the integrity of your clinical data?
April 28, 2017
How is your provider helping you maintain the integrity of your ePRO data?
