Case Study

Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry

iStock-1183744765-map

Complex global drug distribution strategy

Our client, a global top-ten pharmaceutical company, was sponsoring a complex, 8-year Phase III trial across 43 countries. The trial anticipated randomizing 5,000 patients and included 21 different pack types and 24 different drug batches. The study design included 3 treatment groups and 6 stratifications with up & down titrations whenever possible. The distribution strategy included 43 depots and no direct-to-site shipments.

The Sponsor was under intense pressure to reduce trial costs and leverage internal resources. Their original approach was to lead and manage the study in-house, using internal clinical supply resources and expertise. Unfortunately, the internal team quickly ran into difficulty managing the complex drug supply and resupply scheduling. Sites began to experience significant delays as shipments were not released with enough time to get through complex local import regulations. In addition, 24 drug development batches meant 24 different expiration/do-not-dispense dates which quickly compounded into multiple relabeling initiatives. Late scheduling of these relabel campaigns resulted in further shipment delays. Ultimately, study sites began to run out of medication.

VIEW THE CASE STUDY!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Outsourced Pharma? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: