Clinical Trial Supplies: Manufacturing, Packing and Labelling, Including FastTrack™

We offer expert, cost effective, flexible and reliable support for your clinical supplies from Phase I to Phase IV through in depth project management resources to ensure timelines are met.

• Primary and secondary packing
• Blinding and randomisation
• Multi territory label generation
• "Just-in-time" packing
• Cost effective inventory management of high value products

From open to randomised supplies and working closely with our manufacturing and storage and distribution teams we manage labelling, packing and compliance of your clinical trial supplies. We deliver practical solutions resulting in improved compliance of patient packs which can result in significant cost-saving.

All procedures are professionally managed and maintained to the highest standards, conforming to cGMP and all other relevant regulatory standards.

Services include:

• Management of the entire clinical supply process from manufacture through to returns and destruction. We also offer our clients the flexibility of CTS stand alone services to support their requirements
• Versatile labelling and assembly options including just-in-time and batch labelling
• Child resistant senior friendly packaging options
• Blinding of study materials and comparators. Placebo manufacturing/matching
• Sourcing of comparators both in and outside the UK
• Management of controlled drugs
• Named patient and compassionate supplies
• IVRS systems interaction and control
• Quick and cost effective distribution to study sites in both North and South America through our US strategic alliance with Xerimis

Commercial product sourcing for clinical trials

At Penn Pharma, we understand the criticality of controlled sourcing of commercial products for use in clinical studies. Which is why we offer our clients a Commercial Product Sourcing service where we use our knowledge and experience of this area to access the market for the best comparator, rescue medication, concomitant therapy (NIMP) needed for your study taking into account shelf-life, pricing and availability.

Ensuring your clinical trial runs smoothly and effectively is of the utmost importance to us and if you need to use marketed products in a clinical trial, our sourcing, repackaging and distribution services will help you get your study requirements in a safe, compliant and cost effective way.

FastTrack™

Since a large number of molecules fail in Phase I – some sources put the failure rate at over 90% – it is imperative that companies conduct their early phase studies quickly, efficiently and cost-effectively.

The requirement to manufacture Phase I IMPs in accordance with GMP, and to arrange certification by a qualified person, potentially add complexity and time to the process, particularly for those products being imported from outside the EU.

That’s why we are proud to introduce our FastTrack™ team who, depending on the availability of drug materials, can often complete projects within a three-week period or less, instead of six to eight weeks usually associated with a Phase I supply.

Our dedicated, multi-functional, cross-trained teams specialises in preparing materials for early phase clinical studies and consists of experienced people who are trained to perform all steps from the first stage of protocol interpretation through to dispatch of supplies to the investigator site.

Benefits to you

• Potential for much faster turnaround of projects
• Improved delivery and quality
• No handovers from group to group
• Project status is visible at all times as the team works from a single facility
• Projects can be scheduled tightly and kept on track due to the multi-skilled team and their flexibility
• Dedicated QA support is always on hand