CT-FAST is a simulation tool that helps optimize clinical trial supply chain management. It uses integrated Monte Carlo simulation to model patient enrollment, treatment, and inventory management strategies. This allows comparison of different study designs and verification of robustness under various assumptions. The tool leverages actual clinical trial data to initialize simulations and balance user assumptions. It provides what-if analysis, cost-risk tradeoff analysis, and recommendations for optimal supply strategies to increase efficiency and control service levels for complex clinical trial supply chains.

1. CT-FASTSimulation support to leansupplychainmanagementCédric Druckcedric.druck@n-side.com+32 497 31 84 69www.ct-fast.com

2. OutlineIntroduction to clinical trialsThe ChallengeSimulation & optimization

3. OutlineIntroduction to clinical trialsThe ChallengeSimulation & optimization

4. Drug DevelopmentDrugDiscovery(5,000-10,000)Lab, animal testingPreClinicalDevelopment(250)First Human DoseClinicalResearch(5)$550MNDA$350MTo market (1) : 10 years

5. Clinical Trial DesignGLOBAL ENROLLMENT Target number of Patients Investigation Sites Countries Label GroupsSTRATIFICATIONDifferentclasses of patientsBLINDINGTreatmentassignmentisundisclosedRANDOMIZATIONRandomtreatmentassignmente.g. Active/Placebo/ComparatorAABAA?????B?BB??

6. Visits and TreatmentVISIT SCHEDULEPatient returnsat a defined (flexible) scheduleTITRATIONSDosage may change based on events / doctor opinion / …

7. Supply ChainWHAT?Specific (expensive) Kit Types Limited shelf life(potential extension) Limited availabilityDifferent Labels / bookletsHOW? Shipping strictlydownstream, long lead times, sometimes cold-chain

8. OutlineIntroduction to clinical trialsThe ChallengeSimulation & optimization

9. Do it Right7!Don’t let us down!DRASTIC SERVICE LEVELS DEMANDEDPatients healthatstake!

10. The rest of the trouble makers…

11. DealingwithuncertaintyForecasting, simulation, what-if analysis plan, implement, control

12. reduce the costs of the othertwo

13. maintain a high service levelProduction / safety stocksPotentiallyexpensiveJust-in-time: frequentsmallshipmentsPotentiallyexpensive

14. Do itJUST right7!LEANBalance riskand the differentcosts to effectivelyachieve a high service level

15. OutlineIntroduction to clinical trialsThe ChallengeSimulation & optimization

16. Benefits

17. Simulation PrinciplesINTEGRATED MONTE-CARLOEnroll & treat patients – learning setComputeinventory managementstrategiesDistribute kits & match thedemand – validation setEstimate performanceindicatorsWHAT-IF ANALYSISCompare differentstudy designsVerifyrobustnesswith regards to assumptionsREAL-LIFE DATA TOInitializethe simulationsBalance the user assumptions

18. Leveragingactual dataINITIALIZE – Using a snapshot of the trial (patients, inventories…)New batchCurrent stock62 kits51 kitsData estimateWEIGHData

19. AssumptionsBased onAmount of data

20. User confidenceUser estimate

21. CT-FAST Process

22. Cost vs. Risk: Case studyProcessimprovement suggestionsSupplystrategyoptimization