Case Study
Transition Of A Pivotal Global OAB Program Leads To Regulatory Approval
Transition of a Pivotal Global OAB Program Leads to Regulatory Approval The Specific Situation • A t op 20 P har ma w as running their piv otal O AB pr og r am in t er nally . T w o P hase III studies enr olling 2000 t otal pa tien ts a t 160 c ombined sit es acr oss 13 c oun tr ies came under r esour c e c onstr ain ts , leading t o a decision t o outsour c e the pr og r am. • T he Sponsor chose Chilt er n t o take up study managemen t ,