Global Storage, Distribution & Returns

Source: PCI Clinical Services

PCI offers the experience and insights of over 30 years in the storage and distribution of clinical trial materials, effectively storing and shipping thousands of patient kits to over 100 existing and emerging clinical trial countries across the world.

A core part of our service is the development of detailed global supply chain strategies to keep sites supplied with product, while minimizing overage and shipping costs. The key to any successful clinical trial is having a robust, responsive and efficient logistics plan to enable consistent global supply. At PCI, we work with our clients to develop a tailored and dedicated service which meets the needs of their trial requirements whatever the size or number of countries.

Our dedicated teams of logistic experts will handle assembly, dispatch and receipt as well as full evaluation and reconciliation of returns to ensure complete accountability and appropriate chain of custody throughout the trial life cycle.

Secure Storage:

Clinical trial supplies are stored in facilities dedicated to investigational medicines, offering extensive environmental controls and monitoring, meeting full requirements for GMP and GDP. Facilities feature round-the-clock security and environmental monitoring.

PCI has the facilities to store and ship both controlled and dangerous goods throughout the world. Facilities feature vaults which have been approved by the necessary authorities to handle all classifications of controlled drugs, as well as the cutting-edge security systems supported by robust procedures.

Returns Management:

In-keeping with client requirements, we can arrange for the return, storage and ultimate destruction of clinical trials materials at the end of a project. Returns can be reconciled to one of three levels before being securely stored until the approval for destruction is received:

  • Level 1 – reconciliation of the number of shippers returned only
  • Level 2 – reconciliation of the contents of the shippers against a packing list
  • Level 3 – full reconciliation down to individual tablets, capsules, and vials.

Destruction is carried out by an approved third party including witnessed destruction for controlled drugs. Certificates of Destruction are provided to clients to facilitate full reconciliation of clinical trial supplies.