Clinical Supplies Solutions

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Clinical Supplies Solutions
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Clinical Supplies Solutions
Our Goal Optimize Your Clinical Trial
Supplies
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Clinical Supplies Solutions

• Our Expertise

• Objectives
• Processes Tools
• Constraints

• Modeling
• Simulation
• Optimization

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Clinical Supplies Solutions

• Products CT-FAST Modules
• Average Demand Over Time
• Demand and Supply Simulation
• Actual IVRS Data
• High Performance Computing
• Cost Optimization
• Etc.

Clinical Trial Forecasting And Simulation Tool
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Clinical Supplies Solutions

• Services
• Standard/Customized Product Installation
  Training
• Specific Modeling/Development Based on Needs
• Trial Consulting
• General Clinical Supplies Management Consulting
• Clinical Supplies Optimization Strategy
• Organizational Structure, Processes and Tools
• Performance Definition and Measures
• Training Workshops
• Trial Classification Cost/Risk-Based Decision
  Criteria
• Impact of Randomization Scheme, Titration, etc.
• IVRS Automated Inventory Management
• Variability Analysis in Relation to Supplies
  Management

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Leading-edge technology
Business user focus!
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• CT-FAST Benefits
• Enabled accelerated trial execution
• Minimized risk of out-of-stock and over-supply
• Increased control over clinical supplies
• Better allocation of resources
• Standardized processes

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• CT-FAST, The only tool that allows clinical
  supply coordinators to
• Test an unlimited number of scenarios in a short
  amount of time
• Perform sensitivity analyses to minimize risk
  and costs
• Identify the risk associated with any supply
  strategy
• Obtain, as outputs, optimized production plan
  IVRS inventory
• management parameters
• Obtain re-evaluated production plan IVRS
  inventory management parameters for ongoing trials

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The CT Supply Managers Challenge
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The CT Supply Managers Challenge
What if parameters change?
When and how much to produce?
How much safety stock to keep at sites?
What packaging design?
When and how much to ship to Sites?
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How to address this challenge?

• Highly Time Consuming
• Non-Adding Value Tasks
• Limited Outcome

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CT-FAST Enables High-Value Added
Input
Decisions
Automated Calculation
High Value-Added Work
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CT-FAST Enables High-Value Added
Time and Resource Saving
Facilitated Internal Communication
Standardized Methodology
The Right Focus Core RRs
Facilitated Customer Interaction
Decreased Rush Orders
Increased Agility Responsiveness
Decreased Out-of-drugs
Decreased Manufacturing/ Distribution Costs
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What is CT-FAST?

• Automated/Standard Calculation
• Consider All Trial Parameters
• gt Average Demand Over Time

CT-FAST - Start Simple Rapid Results

• Consider Input Variability Risk
• Consider Supply Strategy
• gt Prod Plan IVRS Parameters

CT-FAST - Simulation Precise Comprehensive
Results

• Reduce Uncertainty Over Time
• Re-evaluate Input and Output
• gt Updated Supply Strategy

CT-FAST - Refine Leverage IVRS Actual Data
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CT-FAST - Start Simple Rapid Results
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CT-FAST Start

• Fast Automated Calculation with All Trial
  Parameters
• Standard Method Documentation
• What-If Scenarios

Overview of Trial Demand Over Time
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CT-FAST - Simulation Precise Comprehensive
Results
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CT-FAST Scope
When and how much to produce?
When and how much to ship?
How much to keep at sites?
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CT-FAST Methodology
Trial Demand
Production Plan IVRS Parameters
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CT-FAST Methodology
Trial Demand
Production Plan IVRS Parameters
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CT-FAST Methodology
Production Plan IVRS Parameters

• Scenario 1 Overage 1
• Stock-outs, out-of-drugs
• Shipment frequency volume

• Detailed Report
• Production Schedule
• Qty Produced Used per Package Type
• IVRS parameters
• Out-of-drug Distribution

Select Optimal Scenario

• Scenario 2 Overage 2
• Stock-outs, out-of-drugs
• Shipment frequency volume

• Scenario 3 Overage 3
• Stock-outs, out-of-drugs
• Shipment frequency volume

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CT-FAST Output - Examples
Demand Over Time With Variability
Pack Type A
Pack Type B
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CT-FAST Output - Examples
Out-of-Drug Occurrences In Function of Overage
Out-of-Drugs
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CT-FAST Output - Examples
Trial Production Schedule
Quantity
Batch 1 Coverage
Batch 2 Coverage
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CT-FAST Output - Examples
IVRS Inventory Management Parameters Over Time
Min Stock Level
Max Stock Level
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CT-FAST - Refine Adjust Strategy using IVRS data
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Updated Supply Strategy
Patient Status/TG/Dose Levels Inventory at all
locations
Patient Visits Shipment Receipt
IVRS Data
Automated
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CT-FAST Refine

• Allocate a certain
• WEIGHT to
• Data
• Assumptions
• Based on
• Quantity of Data
• Assumptions Confidence Level

Re-evaluate all parameters
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Data
Data
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Data
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TIME
Less Less Assumptions
More More Data
Enrollment, visit schedule, titration, drop out,
etc.
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CT-FAST Refine
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CT-FAST Refine

• Input Re-Evaluation - Examples

Planned
Enrollment Rate
Re-evaluated
Actual
Drop Out Rate
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CT-FAST Refine
Re-evaluation Time

• Output Re-Evaluation

Demand Over Time
Updated Production Plan IVRS Parameters
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CT-FAST Interface Intuitive Flexible Data
Entry
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Intuitive Flexible Data Entry
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Interface Examples
On-line Graphical Representations
Distribution Network
Data Entry Facilitation
Copy/Paste Buttons
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Data Entry Facilitation
Intuitive Interface
Flexible Level of Detail
Various Study Designs
Re-evaluation of Assumptions
Tool Developed by Clinical Supply Managers
Production Plan as Output
IVRS parameters as Output
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•  Made by clinical supply managers, for clinical
  supply managers.

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N-SIDE Belgium 6 Chemin du Cyclotron 1348
Louvain-La-Neuve
N-SIDE US Science Center 3701 Market
Street Philadelphia PA 19104
Chedia Abdelkafi, Director, Clinical Supplies
Solutions Email chedia.abdelkafi_at_n-side.com Cell
1 717 715 7232
www.N-SIDE.com
www.CT-FAST.com