1. Clinical Supply Management
with Siebel Clinical
April 25, 2013
Parambir Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems
2. Welcome & Introductions
Param Singh
Vice President of Clinical Trial Management Solutions
BioPharm Systems, Inc.
• CTMS practice lead since 2007
– Expertise in managing all phases and styles of clinical trials
– Leads the team that implements, supports, enhances, and
integrates Oracle’s Siebel Clinical solution
• Extensive Siebel Clinical implementation experience
– 12+ years of experience implementing Siebel Clinical
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate
Solution for Siebel Clinical
psingh@biopharm.com | (210) 454-5192
3. Welcome & Introductions (cont.)
CTMS Practice Services
Implementations
Manage implementations of Siebel
Clinical vanilla and BioPharm’s Siebel
Clinical accelerator, ASCEND.
Integrations
Build one- and two-way interfaces
between Siebel Clinical and other
clinical and non-clinical systems.
Training
Develop and/or deliver standard and
custom training classes and materials,
including Siebel iHelp.
Process Guidance
Provide insight, advice, and solutions
to specific clinical trial management
issues.
4. Agenda
• Industry Trends and Challenges
• Clinical Supply Chain Process
• Types of Data Tracked
• Why Use Siebel Clinical?
• Approaches and Demonstrations
• How BioPharm Can Help
• Q&A
5. Trends in Clinical Supply Management
• Pharmaceutical companies are increasingly partnering with
service providers to manage their supply chain
– Moving from one-off interactions to
partnership-based relationships
• Supply chain organizational structure is
becoming increasingly complex
– More trials, more regulations, more regions, more resources
• Increase in cold-chain distribution
– Due to shift from small- to large-molecule drugs
• Accurate supply forecasting becoming
even more important
6. Challenges in Clinical Supply Management
• Accurate forecasting
– Often rely on overages instead of proper forecasting
• Regulatory issues
– Keeping up to date on requirements
– Region-specific rules (import/export regulations, labeling,
packaging)
• Lack of performance metrics
• Service provider selection and management
– Tracking qualifications
• Supply chain communication
– Especially between sponsors and site personnel
7. Typical Clinical Supply Management Process
• Manage and schedule
shipments from
manufacturer to
depots or directly to
sites
Manufacturer
• Store product until
ready to ship to site
Depot
• Receive shipment,
record quantities
received, used,
spoiled, destroyed, etc.
Site
• Send remaining
product to sponsor for
destruction
Sponsor
8. • Quantities and Metrics
– # Units Shipped
– # Units Used
– # Units Destroyed
– # Units Returned
– % Used vs. % Destroyed
• Package Type / Contents
– Ancillary Supplies
– Investigational Product
– Comparator Product
Types of Clinical Supply Data Tracked
9. • Dates and More Metrics
– Needed On-site Date
– Expiration Date
– Site Receipt Date
– Return Date
– # Days Late/Early
– Shipment Turn Around
• IDs and Numbers
– Shipment #, Serial #, Part #, Lot #
• Storage and Handling Requirements
Types of Clinical Supply Data Tracked (cont)
10. Why Use Siebel Clinical?
• Streamline clinical trial management process
– Site initiation, monitoring, and close-out
• Increase inventory level visibility
• Identify areas of improvement
– Problematic sites, shipping, etc.
• Manage service providers
– Track qualifications and past performance
– Manage communication and shipments
• Use past data to precisely forecast supply levels
– Prevent overages and cut costs
11. Why Use Siebel Clinical? (cont)
• Manage Regional Supply Documents and Activities
– Regional supply-specific document templates help
to prevent regulatory nightmares
• Efficiently manage communication
– Track supply-related correspondence
– Manage supply chain contacts
• Eliminate manual tools (spreadsheets)
– Central database prevents discrepancies, easy
backups and restores, more scalable, can be
integrated with other systems
– Validations and auto-calculations prevent human error
12. Clinical Supply Tracking Approaches
1. Siebel Clinical out-of-the-box (OOTB)
2. Tracking with simple enhancements
3. Tracking with medium enhancements
4. Tracking with robust enhancements
13. 1. Siebel Clinical OOTB
• Setup
– Use existing Activities and Document Tracking views
under a site to manage supplies and supply documents
– Add supply-specific LOVs to differentiate from other site
activity and document records
• How It Works
– Supplies and shipments
• Create a site activity record in CTMS
• Select activity type of “Inventory”
• Enter info such as quantity and lot number in
Description field
14. 1. Siebel Clinical OOTB (cont)
• Pros
– No additional cost
– Quick to implement
• Cons
– Tracked with other all non-inventory site activities; could
be confusing
– All information tracked under a generic description field,
making querying and reporting difficult
15. 2. Simple Enhancements
• Setup
– Use existing Activities view under a site to track and
manage supplies
– Add inventory and supply-specific LOVs to differentiate
from other site activities record
– Add additional fields to Activities view to track
inventory-specific data
• How It Works
– Create a site activity record in CTMS
– Select activity type of “Inventory”
– Enter info, such as quantity and lot number, into
corresponding fields
16. 2. Simple Enhancements (cont)
• Pros
– Inexpensive
– Quick to implement
– Slightly easier to query for and report on inventory-
specific data
• Cons
– Tracked with other all non-inventory site activities; could
be confusing
18. 3. Medium Enhancements
• Setup
– Create a new view under Site Management to track
and manage supplies
– Add customized fields to track inventory-specific data
• How It Works
– Navigate to supply management view under a site in
CTMS
– Create an inventory tracking record
– Enter info, such as quantity and lot number, in
corresponding fields
19. 3. Medium Enhancements (cont)
• Pros
– Easier to track, query for, and report on inventory
records when housed under separate views and fields
– Works well for ancillary supplies too
• Cons
– Only captures inventory level at the site
– Does not include inventory level at manufacturer or
depot
21. 4. Robust Enhancements
• Setup
– Create new screens & views to track
• Manufacturer & depot
• Inventory transactions that occur between the depot and site
• Inventory levels at each depot and site
• How It Works
– Create manufacturer and depot records
– Record outbound transactions under manufacturer or
depot as they occur
– Track inventory information for depots and sites, such
as dates, number of units received, and number of units
destroyed
22. 4. Robust Enhancements (cont)
• Pros
– Robust inventory tracking at depot and site level
– Increased inventory level visibility at depot and site
– Optimal querying and reporting capability
– Complete traceability
• Cons
– More effort involved to implement
– Not ideal for tracking ancillary supplies
24. Summary
• Increasing need for tighter management of and greater
visibility into the clinical supply chain
• Siebel Clinical offers robust functionality to support that
need, both OOTB and with enhancements
• 4 approaches to tracking actual clinical supplies using
Siebel Clinical:
1. OOTB Activities View
2. Activities View with Additional Fields
3. New Site Supplies View
4. New Clinical Supplies / Inventory Tracking Views
25. How BioPharm Can Help
• Services
– Demonstrations
– Workshops
– Enhancement development analysis
– Custom development projects
• Products
– Siebel Clinical Supply Management Add-On Module
– Access to BioPharm’s sandbox environment
27. References
1. Kumar, R. S. (2008). Evolving clinical trials.
Pharmaceutical Executive.
2. Lamberti, M. J., Costello, M., & Getz, K. (2012). Global
supply chain management. Applied Clinical Trials.
3. Lamberti, M. J., Costello, M., & Getz, K. (2012). Trends
and novel approaches to clinical supply outsourcing.
Contract Pharma.
4. Lis, F., Gourley, D., Wilson, P., & Page, M. (2009). Global
supply chain management. Applied Clinical Trials.
28. Contact Us
• North America Sales Contact:
– Rod Roderick
– rroderick@biopharm.com
– +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
– Rudolf Coetzee
– rcoetzee@biopharm.com
– +44 (0) 1865 910200
• General Inquiries:
– info@biopharm.com
