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Supply Chain Managementfor Global Clinical TrialsPart 3 of the Clinical Supply Knowledge Share Series: Understanding and Delivering your Global Clinical Supply Chain
Almac Clinical Services
eBook contents
Clinical Supply Chain Management
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The state of
Clinical Supply Chain Management
Section 1Click or tap buttons for more
Resources
The age of biologicsThe evolving role of Supply Chain
Management
State of the industry
The age of biologics
What does a Supply Chain Manager (SCM) do?Luke Moyer
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Resources
Clinical trials are becoming increasingly complex in design, often including double or triple the primary end-points we would have seen just a decade ago. The numbers of participating countries is on the rise as competitive enrolment and the search for naïve subjects is taking us into new regions. In addition, investigational products have become more sophisticated and specialised, increasing manufacturing costs and timelines, while reducing available drug supply. With the estimated cost to bring a new product to market soaring, the ability to make smart and accurate supply chain decisions becomes more critical every day. As such, Supply Chain Managers are facing increasing pressure to conserve drug product and reduce overall IMP costs.
More for less
Market demandsClick or tap buttons for more
Section 2
Supply vs. demand led planning
Stretching supply through drug pooling
Technology and drug conservation
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Section 2
We can never use less drug than is needed for patient demand. Overage is drug product that goes beyond patient demand and it comes from many different sources.
Here are a few sources to consider when factoring overage:
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Minimising waste
Market demandsUnpredictable
demand
Drug product events
Logistical considerations
Inaccurate assumptions
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Section 2
Facing the unknown can be a daunting task. Supply Chain Managers are often tasked with making critical and costly decisions without all of the information they need. SCM’s plan for what “should” happen and what “could” happen, while reacting to what “is” happening. During planning periods with high uncertainty, planners create incremental and iterative forecasts, shortening the planning horizon for packaging and depot re-supplies, so as not to over commit drug product and lose inventory because of expiry.
The SCM will continually monitor forecast accuracy and adjust the planning horizon as confidence in the enrolment forecast grows.
Forecasts should account for high demand while using a planning horizon that reserves expiry for slower than expected enrolment.
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Optimise supply
Market demandsIncorporating actuals
Safety stock
Overage vs. cost
Flexibility by design
Forecast evolution
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Resources
The challengesKey variables affecting clinical supply
Section 3Click or tap buttons for more
Clinical enrolment
Comparator purchase
Temperature management
The impact on larger clinical trialsLuke Moyer
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The physical and digitalClinical Supply Chain
Section 4 ResourcesClick or tap buttons for more
Expertise and consultancy
The physical
The digital
Providingconsultative expertiseLuke Moyer
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Supportingtechnologies
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IRT - Inventory management
IRT - Expiry management
Packaging strategyLuke Moyer
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Almac Supply Chain Management SolutionsNavigating the complexities of the Clinical Supply Chain
Section 6
Forecast and simulationClinical material forecasting, forecast management and simulation tools along with SCM expertise, matches clinical supply to patient demand, ensuring optimised strategies to meet your trial needs.
Inventory managementSupply Chain Managers continually monitor trial supply globally, trending study activities and adjusting future campaigns and material transfers to ensure that the right IMP is at the right place at the right time to meet study demand.
IRT Medication managementSupply Chain Managers consult on the medication management IRT design to meet study needs. They set, monitor and adjust inventory management levels and system expiry strategies to ensure optimisation of IMP while reducing distribution costs where possible.
Label development and regulatory vettingAlmac can oversee label text development, regulatory review, translation and artwork, ensuring that IMP labels meet clinical, regulatory, drug product and country specific requirements.
Temperature management solutionsAlmac’s innovative software program, TempEZ™, supports the full suite of Almac Temperature Services offerings, providing clients with a single central database to store temperature data while ensuring compliance to GxP and GDP regulations.
Bulk drug managementSupply Chain Managers convert finished good demand into upstream manufacturing and API requirements, working with capacity and lead time limitations to avoid downstream supply interruptions and reduce over production and bulk waste.
Other servicesAlmac Supply Chain Managers can provide end to end management of investigator sponsored trials, provide pharmacy services and draft pharmacy manuals. They can also act as unblinded contacts for the site management of clinical supplies.
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The Clinical Supply
Knowledge Share Series
This eBook takes an in-depth look at:• The rise of biologics• Challenges for biologic products• Market pressures• Consideration Checklists
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Look out for our future eBooks
Download our ‘Clinical Supply’ eBook
Section 7
PrimaryPackaging
Temperature Management Solutions
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