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Consultancy

Clinical trial supply logistics

At Eden Biodesign, we recognise that the importance and complexity of Clinical Trial Supply (CTS) qualifies it as a discipline in its own right. We have experience of dealing with a vast range of clinical studies right from single centre, open label studies to ensuring the success of multi-centre and multi-language IVRS controlled studies. 

Our services include:

  • Studying protocol, reviewing and advising on study design
  • Sourcing items and contractor services ranging from comparator products and packaging to specialist couriers and translators
  • Preparing documentation to detail supply requirements and ensuring international CTS regulations are met, as well as cGMP review and approval of contractors’ documentation
  • Managing the logistics of supply from QA release to ensuring maintenance of the cold chain during worldwide distribution
  • Returning and/or destroying used and unused supplies

The pivotal link between clinical product manufacture and the clinical investigator