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.