PCI Launches FastTrack Service

PCI Clinical Services has launched its new expedited clinical packaging, labeling and distribution service called FastTrack. The system is designed to deliver clinical trial supplies for time critical studies in the shortest possible turnaround.

Developed in advance of packaging and operations and maintaining CGMP standards, PCI’s FastTrack service has individual operating procedures and workflows to streamline processes. The company says utilizing in-house label printing capability, FastTrack can complete label design, printing, receipt and Qualified Person (QP) release within 10 days due to a dedicated and specialized team, significantly reducing turnaround time for investigational study supplies and reducing the risk of patient impact due to supply shortage.

For study drug resupply, PCI says it can also complete repeat packing runs and QP release in three days, including label printing, using its dedicated ‘FastTrack: On Demand’ service, allowing flexibility of bulk drug material so it can be used across multiple studies and labeled for a number of countries. Another expedited solution is ‘FastTrack: Just in Time’, which offers sponsor companies increased supply flexibility by the application of a protocol or expiry date label at the point of dispatch within just two days. The Just in Time solution also provides for supply chain strategies such as pooled drug supplies across multiple protocols and a solution to any challenges posed by updates to Annex VI, the regulatory classification system for the labeling and packaging of Clinical products.

“PCI is committed to developing innovative solutions to support our client’s requirements. We have established these new processes with a focus of reducing waste and reducing cost to the client, removing the need to rework supplies when managing multiple protocols,” said Samantha James, associate director, clinical operations, PCI Clinical Services. “It is an exciting time for PCI with the launch of FastTrack which will increase the flexibility and efficiency of our service whilst maintaining our high-quality standards.

“We are always looking at ways to make our client’s lives easier. Introducing FastTrack means that we can offer them the ability to supply Clinical sites with fully packaged and released materials in a matter of days. With our dedicated FastTrack team, we can offer this service without any compromise to the high-quality standards to which we adhere, and will liaise closely with the client to ensure that their time targets are met.”