7 Factors to Consider when Optimizing Clinical Supply Strategies
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Transcript of 7 Factors to Consider when Optimizing Clinical Supply Strategies
DATATRAK Confidential
How do we ensure drug availability? How do we effectively manage costs? How do we effectively manage supply?
DATATRAK Confidential
How do we ensure drug availability? How do we effectively manage costs?
How do we…
How do we effectively manage supply?
DATATRAK Confidential
Supply Cost
Highly Visible Basis for Optimization (usually) Evaluate with other factors
DATATRAK Confidential
Shipping Cost
Controlled substance Temperature controlled Evaluate shipping cost vs. base supply
DATATRAK Confidential
Supply Availability
Abundant supply? Next lot run: Time prohibitive? Cost prohibitive?
DATATRAK Confidential
Time
Lead time to dose Tighter scheme? Controlled substance Temperature controlled
DATATRAK Confidential
Expiration Dates
Expected site enrollment Robust inventory? May be necessary to change schemes mid-study
DATATRAK Confidential
Site Enrollment
Evaluate expected site volumes Consider “peak visit” Ensure drug availability JIT possible?
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Randomization First factor = three treatment regimens Second factor = two MRI levels
6 kit types
DATATRAK Confidential
Visit Dosing Information First two visits need 4 months supply Month 7 - Placebo patients switch to study drug
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Other Limitations $$$ Expensive to produce Limited quantity Temperature controlled $ expensive to ship limits on site storage
DATATRAK Confidential
Initial Supply 4 months of each kit type for one subject Resupply Perform “3-month sweep” Measure inventory for next four months Send enough drug for active subjects