The Clinical Trial Supply chain: Best practice to ensure ... - Almac

Approaches to clinical trial supply management: tips for
improvement
Monitor stock level data
Once a trial starts and recruitment gets into gear, supply stock levels can often start to
deplete at a different rate than expected. Add to this the needs of expiry date
management and soon supplies can start to dwindle. It is essential that stock level data
is monitored throughout the entire supply chain, but due to multiple parties and
systems involved this is not a straightforward process.
Some large Sponsor companies have inventory and management systems capable of
monitoring various portions of the supply chain. When the decision has been made to
outsource portions of the supply chain, Sponsor companies can suddenly find a
gaping hole in any materials management systems. In many cases, once shipped
globally, supplies can disappear totally from the Sponsor’s radar, therefore creating a
reliance on unconnected reports from other systems (mostly 3rd party), which require
manual manipulation of data to forecast future supply needs and manufacturing
requirements.
Meet with sponsor companies and vendors
It is useful to note that as kit inventory is monitored by whatever means selected by
the Clinical Managers, plans must be included to make the information available to
each participant in the supply chain. This means that outsourcing partners need to be
involved in relevant data exchanges that may affect the availability of additional
supplies, and that this involvement occurs in a timely fashion. In our experience, joint
meetings involving Sponsor companies and associated vendors prior to study
commencement are invaluable. Such meetings can present a platform to examine
interface exchanges and possible alternative approaches to the study design. Also, it is
possible to have one vendor responsible for multiple areas of the supply chain,
therefore enhancing control and reducing management concerns.
Supply chain management
A variety of different approaches are available for management of the supply chain
when the study goes live, but the Trial Supply Manager must link the inventory data
back into the complete chain. Examples of inventory management include:
The manual approach
Many Sponsor companies employ a manual approach to the supply chain. Generally
this will mean pre-defining set amounts to ship to each site on activation and then
another set amount for further supplies. This can result in reduced visibility of the
inventory and provide difficulties if sites take on a different level of activity than
predicted. Supplies are usually manufactured/ packaged with at least of 100%