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Locally sourcing, storing and distributing comparators and ancillaries for a global phase III study.

  • Published 06/11/2019
  • Author Darren Leaver - Global Head, Clinical Trial Supply
  • Division Clinical Trial Supply (CTS)

Our client, a top 10 US Pharma company, requested we supply local language comparator and ancillary products into 31 European sites involved in a global phase III study, ensuring continual supply for the duration of the study.

Utilising our network of local manufacturer relationships and global depot network, Bionical Emas were able to offer a single solution to the sponsor to ensure all products would be sourced, stored and distributed in local language within each country. The result was that the sponsor had complete flexibility on when to deliver to each site involved in the study, ensuring all study deadlines were achieved. There was also a significant reduction in the potential wastage which would have resulted from centrally sourcing.

  • All supplies (Inc Ancillary and Comparator) were delivered on time, meeting all the SIV dates
  • No temperature excursions
  • Flexibility to deal with increased demand based on new sites being added during study
  • Weekly inventory level updates were shared to ensure product expiry/quantity would fulfil the remainder of the study
  • Tracked shipments with delivery updates sent to each team member including the clinical site directly if required
  • Worked with CRO alongside the sponsor to ensure all requirements of analytical packs were achieved without jeopardising the main supply to the study
  • 31 clinical sites across Europe

  • 128 subjects

  • 15 products all required in local language

  • 480 packs of auxiliary + 1100 packs comparator

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Bionical Emas CTS are a team of dedicated and passionate individuals, providing unrivalled global access to medicines and ancillaries for use in clinical trials. We provide a customized end-to-end supply solution for our clients, using our global network of manufacturers and authorized distributors, underpinned by our market-leading Quality Management System.


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