Exel, the global leader in supply chain management, today won contracts with SkyePharma Inc., a leading provider of drug delivery technologies, to manage its clinical trials logistics (CTL) from Exel's European Clinical Trials Cell (CTC) in Banbury, Oxfordshire. Exel will manage the importation, provide labelling, packaging, storage and distribution of one of SkyePharma's investigational products into the European Community and Australia, to support SkyePharma's aggressive patient enrollment targets.
SkyePharma's contract award illustrates the confidence Exel's customers place in the Company's ability to respond to customer demand and changing legislation within the European Clinical Trials Directive and Annex 13 to Good Manufacturing Practice (GMP). Exel's operational procedures, and fully-licensed global healthcare sites, provide a compliant distribution environment monitored and controlled to ISO 14644 Class 8 and features clinical capacity for ambient (20oC +/-2 oC) and chilled (5oC +/-3 oC) temperature ranges.
Exel will provide integrated solutions throughout the CTL process - from moving bulk development material from the manufacturing plant through to the safe and controlled destruction of unused patient drug packs. Exel is providing full distribution project management of SkyePharma's two Phase II trials for a sustained-duration local anaesthetic to approximately 20 hospitals across Europe and Australia.
For the customer, Exel will also provide assistance with sourcing and distribution of currently marketed comparator drugs, multi-lingual drug label design and production and secondary packaging.
Anthony Mitchell, Senior Vice President of Exel's Healthcare sector, commented, "Both Exel and SkyePharma understand that effective clinical trials logistics is essential, as competition to speed up drug development processes intensifies. This contract strengthens our position within the clinical trials logistics business and we are delighted to be increasingly involved with innovative drug delivery companies such as SkyePharma."
Steve Thornton, President of SkyePharma Inc., commented "Exel has demonstrated a valuable and reliable end-to-end clinical trials logistics solution, helping us to achieve very short set-up times and the flexibility to immediately react to the supply of new patient recruitments in diverse locations."
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In todays business environment, companies have recognised that it is vital to focus keenly on core competencies and outsource areas of business such as the supply chain. For companies that no longer see the need to develop in-house, complex implementation processes to manage their supply chain requirements, specialist companies such as Exel can provide a solution that can be more cost effective and reduce risk.