Are you able to reconstruct your supply chain genealogy?

Do you have a robust process for drug accountability and destruction?

Is your vendor network and associated suppliers qualified with QP certification?

Have you considered an automated system for drug dispensing and reporting?

Have you defined a valuation policy for investigational products being shipped worldwide?  Do you have a VAT recovery process?

Are you able to maintain a blinded study through the generation of rigorous random codes, appropriate pack outs and strong process controls?

Are you able to support a GxP audit?