Working to both US and European standards, we offer expert, cost effective, flexible and reliable support for your clinical supplies needs. From Phase I to Phase IV, our experienced project management group can advise you on your clinical trial strategy, label and pack design and will ensure that you can meet your study timelines.

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 will 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:

• Manage 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.
• Offer versatile labelling and assembly options including just-in-time and batch labelling
• Child Resistant Senior Friendly packaging options
• Blind study materials and comparators. Placebo manufacturing/matching
• Source comparators both in and outside the UK
• Management of controlled drugs
• Provide name patient and compassionate supplies
• Experience and flexibility of working with various IVRS systems and suppliers
• Our US stategic alliance with Xerimis enables our clients to benefit from quick and cost effective distribution to study sites in both North and South America

Technology:

• Prisym Medica Software for multi-language and CF21/Part 11 validated labels
• Microsoft Project

Fast Track Phase I:

• A dedicated team for early phase and Phase I clinical trial projects
• Seamless, integrated approach in line with Penn's other services
• Each team member is experienced in protocol interpretation to the dispatch of supplies to investigator site
• No transfer project between departments or groups which reduces miscommunication and loss of valuable time.
• Simplicity of documentation reduces the amount of paperwork created but procedures still remains regulatory compliant
• Many projects are completed within a 3 week period or less