Leading pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has today announced the launch of its expedited Clinical packaging, labeling and distribution service FastTrackTM. The system delivers Clinical Trial supplies for time critical studies in the shortest possible turnaround.
Developed in advance of packaging and operations and maintaining rigorous cGMP standards, PCI’s FastTrackTM service has individual operating procedures and workflows to significantly streamline processes. Utilizing in-house label printing capability, FastTrackTM can complete label design, printing, receipt and Qualified Person (QP) release within 10 days thanks 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 can also complete repeat packing runs and QP release in just three days, including label printing, using its dedicated ‘FastTrackTM: On Demand’ service, allowing flexibility of bulk drug material so it can be used across multiple studies and labelled for a number of countries. Another expedited solution is ‘FastTrackTM: 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.
Commenting on FastTrack, Samantha James, Associate Director, Clinical Operations at PCI Clinical Services, said: “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. 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 FastTrackTM 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 FastTrackTM 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.”
Complicated study protocols, demanding deadlines and distribution to remote global destinations can create challenges for delivery and PCI is committed to facilitating the introduction of solutions such as FastTrackTM to provide customers with the services they need.
Now more than ever, timely and efficient delivery of IMPs is considered crucial to the execution of global Clinical Trials. As part of the FastTrackTM service, PCI has appointed a team of highly skilled, dedicated and cross functional staff to conduct multiple tasks efficiently, aligned with QPs at every touchpoint, to ensure the fast and seamless delivery of IMPs to patients in this breakthrough methodology.