Clinical Trial Supply
KLIFO Clinical Trial Supply has more than 18 years’ industry experience in outsourcing and in-house coordination, packaging, labelling and distribution of clinical trial supplies.
A focus on quality
Because we have a fully implemented quality system, our services comply with both EU and local requirements.
Our QP services can assist clients in discussing quality and requirements, performing audits, in the release of IMPs for use in clinical trials and for the importing of products into the EU when necessary.
KLIFO Clinical Trial Supply is inspected biannually by the Danish Competent Authorities, and we hold a Certificate of Compliance as a Manufacturer, with importer authorisation regarding Human Medicinal Products (§39).
Areas of expertise
KLIFO Clinical Trial Supply offers a wide range of services. We are driven by service and seek to understand and meet every client’s needs.
We offer a full portfolio of personalised services and support in clinical trial supply, ranging from supply managers at KLIFO and also based at client companies, to sourcing of products, to handling returns.
We handle all types of trials in all phases, as well as investigator-initiated trials, named patient use and compassionate use.
Our services include:
- Supply coordination
- Outsourcing of supply managerial competences and resources
- Product formulation and blinding
- Comparator sourcing
- Label text and print, including booklets
- Design of patient packs
- Secondary packaging, labelling and compilation
- QP release (batch certification)
- EU import (preparation of QP declarations)
- Review protocols, IMP handling manual
- Code break print
- Storage (-80°C, -20°C, 2 to 8°C, 15 to 25°C)
- IWRS expertise, set-up, testing and managing
- Worldwide distribution (sites and warehouses)
- Contracted local depots in the U.S., Russia, Ukraine, Belarus, Israel and the UK
- Drug accountability
- Returns and destruction
- QP auditing.
With medical advisor support from KLIFO Drug Development Counselling, we have experience in the following therapeutic areas:
- Infectious diseases
All packaging, labelling and storage take place at our headquarters in Denmark. From here, we provide distribution services directly to investigational sites around the world, to local warehouses and other contractors.
We handle ambient or temperature-controlled shipments (2 to 8°C, -20°C, -80°C and 15 to 25°C).
For certain regions, products and trials, the use of local depots/warehouses is recommended. These can be your responsibility, or we can assist you with auditing and the contacting of relevant warehouses.
KLIFO has contracted depots in the U.S., Russia, Ukraine, Belarus, UK and Israel. We also handle importing of products from the U.S., Asia, and more.