Use of IVRS/IWRS for Site Inventory Management

Use of IVRS/IWRS for Site Inventory Management
Cheryl Hudson
Associate Director, Clinical Project Services
Clinical Trial Supply East Coast
October 19, 2011
Site Inventory Management
Effective supplies management that sustains
patient activity without interruption
Optimizes supplies throughout the life of the
study
Sponsor and Vendor Partnership to prevent
supply risks and issues
Visibility of information and tools to aid in
planning and problem resolution
Understanding IVRS/IWRS Capabilities
Partner with IVRS/IWRS vendor
Communicate supply goals and
challenges
Understand how the technology
can meet study needs
Establish responsibilities and
expectations
Application of IVRS/IWRS Site Inventory
Management Strategies
Selection of strategies
Accounting for study constraints
Factors that drive parameter settings
Maintaining flexibility
Importance of reassessment
Define Goals
Recognize
Challenges
Define IVRS/IWRS
Inventory
Management
Design
Reassess Settings
Regularly
Plan for the
Different Study
Phases
Define Resupply
Strategies to meet
protocol specific
needs
Ensure
Maintenance
Responsibilities
are Defined
Acknowledge Goals and Challenges
Supply Goals
Maximize our
Supply
Minimize Wastage
Eliminate Stock
Outs / Failed Drug
Assignments
Minimize
Shipments
Supply Challenges
Supply
Shortages
Costly
Supply
Short
Dated
Material
Long
Transit
Times
Shipping
Costs
Site
Storage
Space
Larger (infrequent)
Shipments
Keep more supply at site
• High Supply Availability
• Low Supply Cost
• Long Use By / expiry
dating
• Long Transit Times
• High Shipping Costs
Smaller (frequent)
Shipments
Keep less supply at site
• Low Availability
• High supply Cost
• Large Pack size/ Low
Site Storage
• Shorter Use by / expiry
dating
• Short Transit Times
• Low Shipping Costs
Cover Subject Need
New Subjects
Replacements
Existing
Subjects
Common Site Inventory Management
Methodologies
Randomization Projections
Visit Projections
Trigger and Resupply
Site Stratified Randomization
Site
Rand #
Treatment
101
1
10 mg
101
2
20 mg
101
3
15 mg
101
4
15 mg
Status
When should you use
Randomization Projections?
Site Stratified
• Blocked
• Site + Subject Stratified
• # factors
Central
• Central
• Subject Stratified
How many patients to project
randomization for?
• Can we use screening as a
predictor?
• What is the expected enrollment
rate?
• What is the transit time?
• How many randomization numbers
are maintained at the site?
[assuming dynamic allocation of
randomization codes]
Visit Projections
• Using the visit schedule,
IVRS/IWRS knows when subjects
are expected to come in for visits
and what treatment they are on
Projection Time Frame
Short Projection Timeframe Long Projection Timeframe
Transit Time
Short
Long
Use by / Expiry Short
Long
Drop Out Rate
High
Low
Supply
Availability
Low
High
Site Storage
Space
Low
High
How far should I project for visits?
Transit Time
• Projection window must be greater than transit time
Expiry Dating
• Balance your ‘do not ship’ with projection timeframe
Visit Schedule
• How often do patients come in (visit schedule)
• Avoid 1 for 1 replacements / partial unblinding
Trigger and Resupply
• New Enrollers
• Buffer Stock for replacements
Tying it all together
Rand
projection
Visit
projection
Trigger &
Resupply
Site
Ordering
Needs
Study Phases
Enrollment
Maintenance
Close Out
• Keep higher buffer
supply to account for
new enrollment
• Routinely placing
drug orders
• Keep less buffer
stock as subject
schedule is know
• Buffer only needed
for replacements
• May be able to
decrease schedule
for placing of drug
orders
• Plan for last patient
drug assignments
• Schedule last day of
drug ordering
Technology vs.
Human Oversight
Reports and Alerts
• Who is looking at these?
• What does the data mean?
• Who is responsible for
action?
Routine Oversight
• Who’s responsible
Indicators
• # shipments per site / month
• Stock outs / Failed Drug
Assignments
• Site Usage rate
• Depot Usage rate
Flexibility
• Initial assumptions and
strategies may not align with
reality
• Ensure that the system is
easily adaptable
• Ensure system adaptability
for different site / regions