Business solution
KLIFO Clinical Trial Supply Solutions optimises clinical trial supply by offering proactive management throughout the supply and logistics process.
Our international reach, highly flexible solutions and compliance with EMA, FDA and national requirements mean that we can accelerate project set-up, reduce turnaround times and minimise supply chain issues.
Christina Vinum
VP
Christina Vinum joined KLIFO in February 2011 as Senior Clinical Trial Supply Coordinator and became Director of Clinical Trial Supply in January 2012 and VP: Clinical Trial Supply in 2014. Christina has more than 15 years experience with clinical trial supplies, first at Nycomed from 2001 as Clinical Trial Supply Coordinator and, from January 2009, as Head of Clinical Supply for Nycomed CTS departments in Denmark and Germany.
Direct/mobile: +45 44 222 960
Email: moc.ofilk@muniv.anitsirhc
Expertise &
therapy areas
Expertise
KLIFO Clinical Trial Supply Solutions has the end-to-end know-how and can meet all your supply needs:
- Supply management
- Outsourcing of supply managerial competences and resources
- Product formulation and blinding
- Comparator sourcing
- Setup of English Master label text
- Translation and regulatory review of label texts
- In-house Label print and check, including booklets
- Design of patient packs
- Secondary packaging, labelling and compilation
- QP release (batch certification)
- EU import (QP declarations)
- Randomisation
- Review of protocols and other study specific documents
- Prepare and review IMP handling plan
- Code break print
- Storage (-80°C, -20°C, 2 to 8°C, 15 to 25°C)
- IRT expertise, set-up, testing and managing
- Worldwide distribution (sites and depots)
- Contracted local depots in the U.S., Russia, Ukraine, Belarus, Georgia, Israel, Singapore, Australia and the UK
- Drug accountability
- Returns and destruction
- QP auditing
- Direct to patients setup
- Clinical Supply Chain Advice
- Choosing an adequate transport-provider
- Minimize risk, increase efficiency, and optimize the supply chain
- Preparation of import / export documentation that complies with local laws and regulations
- Packaging under different temperature ranges, Ambient, 2-8 C°, -20C° and -80 C°
- Packaging and labelling of IMP in US
450+
700,000+
5,000+
Our expert staff
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Helle ViufClinical Supply Assistant
Helle joined KLIFO in January 2010 as Clinical Supply Assistant. Helle has more than 16 years of experience from working with clinical supply packaging at Lundbeck and in KLIFO.
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Berit SchultzSenior Clinical Supply Manager
Berit joined KLIFO February 2018 as a Clinical Supply Manager.
Berit has a background as Cand. Scient Biokemi and are managing and coordinating studies with a good technical and approach. -
Annette SimonsenSenior Clinical Supply Manager
Annette Simonsen joined KLIFO January 2017 as a Clinical Supply Manager. Annette has more than 25 years’ experience within clinical trial supplies from working with Novo Nordisk, Genmab and Lundbeck.
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Pernille SmithTeam Manager
Pernille joined KLIFO in May 2018 as Clinical Supply Manager. In February 2019, she became Team leader for the Clinical Trial Supply Management team. Pernille is an expert in packaging and labelling for clinical trials and has 20 years’ experience in consulting the pharmaceutical industry.
Direct/mobile: +45 44 22 29 86 / +45 93 63 91 03
Email: moc.ofilk@htims.ellinrep