Chain reaction
As the number of clinical trials being conducted
worldwide increases, so does the need to
choose the best partner-providers. Lekishia Moffett
White of Multipharma advises on how
to secure every link in the supply chain.
Perhaps due to recent legislation, efforts to
standardise regulations and the public attention
being given to healthcare, it is acknowledged
that
clinical trials are increasing in number.
In addition, there is an overall industry requirement
to
compare the best-in-class competing pharmaceuticals
so that the market is supplied with the best therapeutic
remedy available, which is of high quality, safe,
effective
and affordable.
It has even been speculated that, by 2020, the
number of
clinical trials being conducted within the emerging
markets of
Asia, Eastern Europe and Latin America will be
equal to that
of the US and European Union combined. As a consequence,
management option assessment for global clinical
trials
supply is now a requirement.
As a result of mergers and acquisitions, the
number
of partnerships that need to be developed within
the
industry has also increased. This has and will
continue
to amplify the complexity of managing the clinical
trial
supply chain.
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"Finding a partner
with sufficient global reach ensures delivery
of the right material in the right amount
to the right place at the right time in
the right manner."
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Business plans and core business functions are
being evaluated and strategic partnerships are
being formed to ensure that all necessary capabilities
required to manage such supplies are being fulfilled
by the most qualified organisation.
The ‘five Rs’
Finding a partner with sufficient global reach
and the ability
to demonstrate a secure, reliable and repeatable
supply chain
will ensure delivery of the commonly identified
‘five Rs’ of
getting the right material in the right amount
to the right
place at the right time in the right manner.
Unfortunately, the details surrounding the logistics
and
distribution of clinical trials supplies are often
ignored. As
a result, if not planned for appropriately, supplies
will not
be delivered to the patient as necessary. Point-to
point
and just-in time distribution as well as proof
of supply
pedigree are but a few of the characteristics
of the supply
chain that should be tested as reliable and traceable.
Consequently, adequate depot management and
distribution of inventory should be verified and
compliance to all applicable regulations and controls
should be audited periodically.
A thought process to consider prior to entering
into a
partnership for the full logistical support of
clinical trial
supply management is as follows:
As a guide, consider the following requirements
when
assessing the capabilities of a partner to fulfil
its duties as
a provider of logistical support. Ask yourself:
- is clinical trial supply management a core
competency
and business function?
- Is the provider appropriately licensed/accredited?
- Does the facility have an international presence?
- Are appropriate procedures in place and can
they be
executed effectively?
- Does the site have adequate temperature and
security
monitoring systems?
- Does the facility have generator back-up capabilities?
- Are communication, emergency response and
disaster
recovery plans developed?
- Was the site visit/overall audit favourable?
Fortunately, there are several global organisations
that
can assist the industry by providing full logistical
support
of warehousing and distribution activities for
clinical trial
supplies. It is recommended that after confirming
the
complementing capabilities of the organisations
involved,
you further evaluate if a potential partner can:
- gather information and present flexible options
via
a global network
- provide transparency
- mitigate and control costs
- offer services in terms of project management
- give unbiased clinical trial supply advice
Each clinical trial should have its own distribution
network that can securely deliver clinical trial
supplies
without incident to destination points. Therefore,
in
summary, have a standard requirement where policies,
processes and procedures are in place and are
being
performed accordingly, and if a partnership with
a
specialised competent provider is required, ensure
that
they can deliver on the five Rs. Last but not
least, have
a viable back-up and an exit plan.
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