Published on March 10, 2014
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 firstname.lastname@example.org | (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
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
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
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
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.
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