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The Clinical Trial Supply Chain – Before and After the Trial Start
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The Clinical Trial Supply Chain – Before and After the Trial Start
Date
Everybody is more than familiar with • Appropriate storage of completed
the fact that clinical trials generally are and released supplies
getting larger, more complex and • Packaging and labeling of supplies
reaching to the farther edges of the • Material requirements for
globe. Not to mention that the packaging and labeling
timeframes involved are shrinking! In • Production and supply of bulk IMP
the world of outsourcing, a lot of trials
seem to come as a surprise, both to the Acting on this information alone,
client and to the vendor, with whom shared in soft focus with either an in-
they partner in the packaging and house clinical supply unit or potential
distribution process. Each party has a vendors allows a certain amount of
distinct common goal in terms of pre-planning. This in itself can start to
reaching the effective trial start date reveal potential problems, bottlenecks
(first patient in) and ensuring that each and possibly some solutions for: -
patient and site is supplied with the
correct medication at the right time. • Bulk drug availability
• Material purchase lead times
Clinical trial supplies more often than
• Production capacity constraints
not occupy the critical path bottleneck
• Opportunities to produce generic
in terms of availability, therefore
stock that cross several trials
affecting cycle times for getting new
drugs to market. There are a number of
best practices and tools that can be
Often, it is seen that in effect the actual
used both before and during the trial to
required start date for trial activities
ensure that the clinical supply chain is
has already passed. It is useful, when
managed more effectively and operates
preparing the Protocol for the clinical
more efficiently.
trial, that the Clinical teams plan a time
point when individual clinical supply
Working backwards
requirements are “frozen”. This allows
the ticking clock for trial start date to
Sponsor companies should have a plan
be reset after any alterations to the set
of activities; this should not be a
supply requirements. Examples for this
crystal ball exercise. Lead candidates
are primary packaging, kit formats,
and pipelines for each year generally
required quantities and everyone’s best
are known in advance (1-2 years) and
friend, label text.
this information can be a precursor to
The clinical supply chain must be seen
demand forecasting and production
as a global one – from raw materials
planning if shared and used correctly.
right through to world-wide
The clinical trial start dates work
distribution to customers (the patient).
backwards for both the sponsor, and
outsourcing partner in terms of being
able to identify the lead times for :-
• Shipping to the study sites (after all
necessary approvals are in place)
The Clinical Trial Supply Chain – Before and After the Trial Start
Date
the initial supply of kits become
Clinical Supply Inventory Chain
absolutely critical to continuous patient
BULK IMP
supply. Now we enter a crucial phase.
Site inventory
CENTRAL
Packaging
components
PACKAGED After study initiation, monitoring of
TRIAL SUPPLY
STOCK
clinical supply inventory throughout
Depot inventory the supply chain is essential in order
Label text
to: -
Trial FPI date Resupply – trial running • Examine study kit usage and
available stock levels
• Ensure the drug is always available
Figure 1- Working back from expected for patients
First Patient In (FPI) Date • Minimise waste medication (it is
expensive!)
• Alert sites in case of potential
When there is an overview of all supply delays
scheduled trial supply requirements, • Comply with GMP/ GCP
the planning process can enter into a conditions such as expiry date
more detailed phase noting each management and accountability
deliverable component required to
produce the supplies for the study start
date. Without going into the mechanics
of project management, the trial
manager will of course balance CTA Approaches to clinical trial supply
submissions and approvals, along with management
country specific requirements, in
parallel with the production of the Once a trial starts and recruitment gets
clinical trial supplies and its associated into gear, supply stock levels often
inventory chain. start to deplete at a different rate than
expected. Add to this the needs of
Stock levels and tracking of clinical expiry date management and soon
trial supplies supplies can start to dwindle. It is
essential that stock level data is
Once the clinical trial supplies are monitored throughout the entire supply
available to commence a trial, the chain, but due to multiple parties and
tracking and monitoring process can systems involved this is not a
begin to ensure that stock levels of kits straightforward process.
are maintained and that the supply to
each patient is continuous and Some large Sponsor companies have
uninterrupted. Usually for later phase inventory and management systems
trials with large patient populations, capable of monitoring various portions
supplies are delivered in phased of the supply chain. However, when
campaigns, often due to expiry date the decision has been made to
limitations or comparator availability. outsource portions of the supply chain,
This in turn means that stock levels of Sponsor companies suddenly find a
The Clinical Trial Supply Chain – Before and After the Trial Start
Date
gaping hole in any materials but the Trial Supply Manager must
management systems. Also in most link the inventory data back into the
instances, once shipped globally, complete chain. Examples of inventory
supplies can disappear totally from the management include : -
Sponsor’s radar, therefore creating a
reliance on unconnected reports from
other systems (mostly 3rd party), The manual approach
which require manual manipulation of
data to forecast future supply needs Many Sponsor companies employ a
and manufacturing requirements. manual approach to the supply chain.
Generally this will mean pre-defining
Another inherent problem can be that set amounts to ship to each site on
various inventory reports and stock activation and then another set amount
levels are available, but the supply for further supplies. This can result in
chain is not covered for each required reduced visibility of the inventory and
component and does not look back in provide difficulties if sites take on a
totality to bulk material and component different level of activity than
availability. predicted. Supplies are usually
manufactured/ packaged with at least
It is useful to note that as kit inventory of 100% overage, therefore adding to
is monitored by whatever means the trial cost and lead times for
selected by the Clinical Managers, production. Study monitors can
plans must be included to make the provide inventory verification but this
information available to each approach can lead to a fragmented
participant in the supply chain. This approach if multiple supply campaigns
means that outsourcing partners need are required.
to be involved in relevant data
exchanges that may affect the
availability of additional supplies, and Use of Interactive Voice Response
that this involvement occurs in a Systems (IVRS)
timely fashion. In our experience, joint
meetings involving Sponsor companies Traditionally both IVR, and similar
and associated vendors prior to study web based systems have been the
commencement are invaluable. Such scope of large Phase III trials, with
meetings can present a platform to complex dosing and inventory
examine interface exchanges and requirements. However the quality of
possible alternative approaches to the reporting tools available and
study design. Also, it is possible to management of randomisation has
have one vendor responsible for encouraged increased use within the
multiple areas of the supply chain, industry. An IVRS provides full
therefore enhancing control and visibility of released finished patient
reducing management concerns. kits held in Sponsor, or third party
depots, and also at the study sites.
A variety of different approaches are
available for management of the During study set up, it is usually
supply chain when the study goes live, decided to supply sites either by using
The Clinical Trial Supply Chain – Before and After the Trial Start
Date
defined stock levels that are resupplied strategies. In combination with IVR or
based on various set trigger points, or in isolation, these can be effectively
by a just-in time delivery (for each used upfront to help decide on actual
patient visit) depending on the best fit site supply strategies. Forecasting can
for the study. also be used to estimate how long
quantities of supplies will last for. This
Ultimately, this can assist the clinical can be particularly useful when the
trial supply chain in not only study has commenced and forecasts
presenting alerts for low stock levels at need to be made covering the entire
sites, but also in country or central supply chain for resupply of study kits.
depots such as a contract
packager/distributor. The ability to Electronic Data Capture (EDC)
manage the supply chain at site, systems in the supply chain
country depot and central depot allows
the trial medication to be managed Although primarily for quality data
more effectively, and can assist in the collection, certain data sets within
overall supply chain. Again, lead times EDC systems can be used by
for all components (such as bulk drug) distributors to predict an efficient just-
and production of supplied kits, means in time drug supply, again helping
that careful monitoring of this interface effective monitoring of inventory and
is required. reduction in waste drug. By using
patient enrolment information and also
It has already been possible by establishing specific dispensing visit
agreeing common data set protocols to timetables, inventory can be managed
permit data interchange between IVR between a distributor and EDC system.
and distributor systems to facilitate In our experience, this approach can
electronic ordering of patient supplies. work well for trials with simple
Although not full integration, it does at dispensation rules and minimum
least serve to enhance reporting, dosing scenarios.
visibility and ordering efficiency,
especially when integrated with bar
coding of the clinical supplies. By Future solutions
utilising a vendor with both
distribution and IVR expertise, the trial Several companies involved in
supply can be integrated with input on outsourcing have attempted
streamlining trial set up and successfully the process of data
management of drug inventory. integration on specific parts of the
supply chain. However the main issue
Forecasting programs remains that with so many differing
in–house systems and services
Programs are available that can provided by third parties that solutions
simulate different trial supply tend to be point to point. As a result
scenarios and model the affect of using Sponsor companies that use a suite of
differing variables in terms of patient tools to manage the clinical trial supply
recruitment levels, the quantity of site chain face multiple areas of data
shipments and multiple site supply integration. Each of these requires
The Clinical Trial Supply Chain – Before and After the Trial Start
Date
programming, testing and validation Conclusion
for each source in the chain. Likewise,
the vendors also will have this problem Sponsor companies can assist the
for each Sponsor Company they are clinical trial supply departments both
involved with. within their own company and
outsourcing partners, by planning
However, this may not be the case in ahead and giving some visibility to the
the future. Organisations such as drug development plans. This will
CDISC (www.cdisc.org) are working assist in management of demand
to establish guidelines for data transfer forecasting and capacity, and also
standards, which could provide a identify potential problems in advance.
platform for future integrations. Also
file transfer protocols, such as XML, Further use of technology to control
offer enhanced possibilities for data and manage various parts of the
transfer. Data portals that allow clinical supply chain means that data
multiple sources to “speak” using an integration needs will grow within the
integration layer present an industry. Organisations will strive to
opportunity for automated data sharing focus not only on operational
between companies, therefore feeding expertise, but also on the ability to
data from site, depot and the integrate into set data standards that
manufacturing facility to allow tighter allow them to take their place in an
supply chain integration. integrated supply chain.
References:
INVENTORY VENDOR IVRS SITE/ DEPOT
SYSTEM
INVENTORY INVENTORY 1: World-class clinical supplies, Drug
Information Journal
BULK MATERIALS
SUPPLY
STRATEGIES
MATERIALS Vol 31, pp 697-714, 1997
DRUG STUDY KITS STUDY KITS
STOCK LEVELS
Data integration layer
Reports – automated supply management
Figure 2- future data standardisation
allowing automated supply chain
integration
