Samantha James, PCI’s Associate Director of Clinical Operations

Samantha James, PCI’s Associate Director of Clinical Operations

Leading pharmaceutical provider PCI Clinical Services, in partnership with Medicon Valley Alliance, will share its expertise at the upcoming Clinical Trial ‘Good Morning’ seminar: “Minimizing Time to Clinic by Maximizing Smart, Efficient Processes” (Copenhagen, November 22).

The event will feature presentations from industry experts across a range of topics highlighting innovative practices to supply clinical trial medicines to the investigational sites.

Samantha James, PCI’s Associate Director of Clinical Operations, will present on the topic of FastTrack Packing: Handling Adaptive Clinical Trial Designs and Maximizing Efficiencies. James will discuss the use of advanced methodologies to create greater project flexibility, including FastTrack packaging and Just-in-Time logistical models.

James stated: “As the complexity and competition surrounding clinical trials increases, there is a growing need to get drug to site sooner without compromising efficacy and quality. We have a number of services that support client’s requirements. FastTrack offers rapid study set-up, packaging, labelling and distribution for clients that require their clinical trial data as quickly as possible. For clients with limited drug supply or short shelf-life, we are able to offer a Just-in-Time solution that maximizes their flexibility in administering studies, managing resources and yield expedited results.”

Rishi Saini, PCI Data and Systems Developer, and will discuss Inventory Management: At Your Fingertips, looking at PCI’s Webflow supply chain portal. Saini commented: “Web and mobile-based technology continues to drive change in the way companies manage their clinical trials, with the availability of real-time information, paramount to a successful project outcome. PCI’s Webflow system is a bespoke client access portal that provides real-time access to projects 24/7 and allows clients to configure information on the specific needs of their global trials. During the presentation, I will be addressing the unique features of the Webflow System and demonstrating how clients can benefit in the administration of their trials by virtue of real time technological access to their inventory.”

The programme will also feature expert commentary from Beth Halliday, Qualified Person (QP) at PCI. Halliday will be explore the updates and impact of the Annex 16 guidance, Certification by a Qualified Person and Batch Release. The Annex has recently been revised to reflect the globalization of the pharmaceutical supply chains and the introduction of new quality control strategies.

It also incorporates the requirements of the Falsified Medicines Directive and implements the ICH Q8, Q9 and Q10 documents. Halliday will be highlighting some of the key changes and their impact on QPs, sponsor companies and manufacturers, such as supply chain complexity, documentation and audit requirements, QP Certification of Partial Manufacturing, sampling in a third country and more.

For more information and to register for free to the event please visit: http://pciservices.com/events/copenhagen-seminar/.