Clinical Supply Management with Siebel Clinical April 25, 2013 Parambir Singh Vice President of Clinical Trial Management Solutions BioPharm Systems
Clinical Supply Management
with Siebel Clinical
April 25, 2013
Parambir Singh Vice President of
Clinical Trial Management Solutions
BioPharm Systems
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
[email protected] | (210) 454-5192
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.
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
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
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
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
• 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
• 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)
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
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
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
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
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
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
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
Demo
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
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
Demo
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
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
Demo
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
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
Q&A
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.
Contact Us
• North America Sales Contact:
– Rod Roderick
– +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
– Rudolf Coetzee
– +44 (0) 1865 910200
• General Inquiries: