2013 OHSUG - Best Practices for Setting up the CDA Repository for CTMS/OC
Clinical Supply and Inventory Tracking with Siebel Clinical
1. Clinical Supply and
pp y
Inventory Tracking
with Siebel Clinical
Karen Ouyang
1
2. Agenda
Topic
Welcome and Introductions
Clinical Supply & Inventory Tracking
Overview & B
O i Benefits
fi
Approaches to Clinical Supply &
Inventory Tracking in Siebel Clinical
Demonstration of Different
Approaches
Q&A
2
3. Welcome & Introductions
Karen Ouyang
y g
Senior Consultant – BioPharm
Systems, Inc.
• Over 6 years of experience in Siebel
• 7 implementations of Siebel Clinical
• Experienced in implementation,
integrations, enhancement releases,
and upgrades
3
4. Agenda
Topic
Welcome and Introductions
Clinical Supply & Inventory
Tracking Overview & Benefits
T ki O i B fit
Approaches to Clinical Supply &
Inventory Tracking in Siebel Clinical
Demonstration of Different
Approaches
Q&A
4
5. Inventory Tracking
Overview
In Scopep
• Distribution of Investigational
Product to Site
• Distribution of Ancillary Products
to Site
Out of Scope
• Distribution of Investigational
Product to Subject
5
8. Benefits of Inventory
Tracking in Siebel Clinical
• Streamline clinical trial
management process
– Site Initiation
– Site Monitoring
– Site Close-out
• Increase inventory l
level visibility
l bl
• Eliminate spreadsheets tracked
outside of system
t id f t
8
9. Agenda
Topic
Welcome and Introductions
Clinical Supply & Inventory Tracking
Overview & B
O i Benefits
fi
Approaches to Clinical Supply &
Inventory Tracking in Siebel
Clinical
Demonstration of Different
Approaches
Q&A
9
10. Tracking Approaches
• Siebel Clinical OOTB
• Tracking with simple
enhancements
• Tracking with medium
enhancements
• Tracking with robust
enhancements
10
11. Tracking w/ OOTB
What It Does
• Use existing Activities view under
a Site to track inventory & supply
to site
• Add inventory & supply specific
LOVs to differentiate from other
site activities record
11
12. Tracking w/ OOTB
How It Works
• Create a site activity record in
CTMS
• Select Activity Type of
“Inventory”
• Enter info such as quantity & lot
# in “Description” field
12
13. Tracking w/ OOTB
Pros
• No additional cost and quick to
implement
Cons
• Tracked with other non-inventoryy
site activities
• All info are tracked under a
generic description field
13
14. Tracking w/ Simple
Enhancements
What It Does
• Use existing Activities view under
a Site to track inventory & supply
to site
• Add inventory & supply specific
LOVs to differentiate from other
site activities record
• Add additional f ld to Activities
dd dd l fields
view to track inventory specific
data
14
15. Tracking w/ Simple
Enhancements
How It Works
• Create a site activity record in
CTMS
• Select Activity Type of
“Inventory”
• Enter info such as quantity & lot
# in corresponding fields
15
16. Tracking w/ Simple
Enhancements
Pros
• I
Inexpensive cost and quick to
i t d i kt
implement
• T
Track i
k inventory related data in
t l t dd t i
separate fields
Cons
• Tracked with other non-inventory
site activities
• Inventory specific fields may be
confusing when tracking other
activity records 16
17. Tracking w/ Medium
Enhancements
What It Does
• Create a new view under a Site to
track inventory & supply to site
• Customize fields to track
inventory specific data
17
18. Tracking w/ Medium
Enhancements
How It Works
• Navigate to Supply Tracking view
under a in CTMS
• Create an inventory tracking
record
• Enter info such as quantity & lot
# in corresponding fields
18
19. Tracking w/ Medium
Enhancements
Pros
• E i t track inventory records
Easier to t ki t d
under separate view & fields
Cons
• Only capture inventory level at
the site
• Does not include inventory level
at manufacturer or depot
19
20. Tracking w/ Robust
Enhancements
What It Does
• Create new screens & views to
track
– Manufacturer & depot
– Inventory transactions occur
between depot & site
b t d t it
– Inventory level at depot & site
20
21. Tracking w/ Robust
Enhancements
How It Works
• Create manufacturer & depot
records
• Record outbound transactions
under manufacturer or depot as
they occur
• Track inventory info such as Date
Received & # Destroyed related
d d l d
to each transaction under depot
or site
21
22. Tracking w/ Robust
Enhancements
Pros
• R b t inventory tracking at
Robust i t t ki t
depot & site level
• I
Increased inventory level visibility
di t l l i ibilit
at depot & site
Cons
• More efforts involved to
implement
• Not ideal to track ancillary
supplies
22
23. Agenda
Topic
Welcome and Introductions
Clinical Supply & Inventory Tracking
Overview & B
O i Benefits
fi
Approaches to Clinical Supply &
Inventory Tracking in Siebel Clinical
Demonstration of Different
Approaches
Q&A
23
25. Agenda
Topic
Welcome and Introductions
Clinical Supply & Inventory Tracking
Overview & B
O i Benefits
fi
Approaches to Clinical Supply &
Inventory Tracking in Siebel Clinical
Demonstration of Different
Approaches
Q&A
25
27. Closing
Thank you for attending!
This tutorial will be posted on
[
[website] by?
] y
27
28. Contact Info
Karen Ouyang
650-292-5312
kouyang@biopharm.com
http://www.BioPharm.com
28
29. Speaker Bio
Karen Ouyang
Karen Ouyang is a Sr. Consultant in the
BioPharm’s Siebel Practice group and has
been working with Siebel for over six years
years.
She specializes in Siebel Clinical and her
experience has been heavily focused on
business process analysis, requirement
analysis
definition, functional design, application
testing, training/change management, and
system deployment. Karen is based in Los
Angelas, California, and has been with
BioPharm since Fall 2008.
29
