Clinical studies are becoming more and more complex, with new regulatory requirements to adapt to and increased pressure on timelines and budgets. And the less-complex, larger-scale packaging & labelling campaigns for Phase III trials can be just as challenging.
Regardless of the study phase, the size of the trial, dosage forms or trial design, Clinigen Clinical Supplies Management has the experience and capacity to ensure the successful packaging and labelling of a trial drug. Our long history with Investigational Medicinal Products (IMPs) generated vast expertise in larger-scale batch packaging, both primary and secondary.
Read on to discover how we supported a recent Phase III multinational trial involving 28 different sites across Europe and the US.
Clinigen’s larger-scale P&L capabilities can be exemplified in a recent study supported by our German site for a biopharmaceutical company focused on developing novel treatments for endocrine diseases.
The large Phase III double-blind study lasted 20 months, with 150 patients in 8 different countries. With three different treatment groups, this involved a total of approximately 64,000 vials of active medication and 25,000 placebo vials. Each patient kit contained eight vials, and both the vials and the carton had to be labelled with multinational booklet labels. We also provided ancillary supplies such as syringes, needles, alcohol pads and biohazard disposal containers. Using semi-automatic vial and carton labelling, we performed several large packaging runs. Our team coordinated the temperature monitored shipment to 28 sites, across different countries in Europe and the US.
The project also involved a review of batch documentation by Quality Assurance/Quality Control and batch certification by a Qualified Person (QP) for the IMP entering the EU.
All patient kits were packaged and labelled within the required timeframe for initial supply and resupply. We managed to reach the tight First Patient In (FPI) timelines by starting with three smaller packaging runs for the initial supply, followed by the full-size batch packaging & labelling runs for the resupply.
Since 1997, Clinigen Clinical Supplies Management has been developing processes and tools for bigger packaging runs, including semi-automatic vial and carton labelling. Acting as your global partner that’s part of Clinigen Group with a supply chain facility, depot and supplier network servicing numerous clinical trials worldwide, over 80% of the trials we’re supporting are multinational.
Our history with larger-scale packaging and labelling projects allows us to deliver trusted solutions which protect and identify study medication during storage, distribution and use. We offer extensive primary and secondary clinical trial packaging services and deliver compliant and effective packaging design for your study. With flexibility at our very core, we can react quickly to client requests and add emergency short-term packaging runs, as needed, in case of an early study start or when an urgent need comes up. What’s more, our proprietary ERP tool, eCEMS, allows clients to track warehouse and site inventories in real-time, making the process highly interactive and flexible.
Clinigen’s commitment to ensuring the highest quality standards of clinical supplies is backed by over two decades of experience supporting pharmaceutical companies with a combination of knowledge, expertise, innovative processes and a dedicated team of specialists.
Read more about our extensive, global primary and secondary clinical trial packaging services.
We understand that the Packaging & Labelling of a drug is a complex and vital piece of a clinical trial. Contact us today to discuss how we can support your clinical packaging project.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.