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

psingh@biopharm.com | (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

– 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