End to end Clinical Trial Supply Management with SAP by Infosys Lodestone CTSM is a leading factor in conducting clinical studies.
Table of Contents A Leading Factor in conducting Clinical Studies is the Efficient Management of Clinical Supplies... 3 Clinical Trials Supply Management... 4 Challenges... 5 How SAP Technology can Help... 6 SAP Alone is Not the Solution... 8 Conclusions and Recommendations... 10 Authors... 11 2
A Leading Factor in conducting Clinical Studies is the Efficient Management of Clinical Supplies Clinical trials are an essential part of the product development process for both pharmaceutical and biotech companies and if run efficiently can provide the company with a competitive advantage. Clinical trials also form a major component of the overall cost of drug development. Stakeholders point to the clinical costs as a barrier to innovation. The FDA has confirmed as part of its Critical Path Initiative that Streamlining Clinical Trials is one of the key priorities June 2008 (http://www. fda.gov/oc/initiatives/criticalpath/report2007.html). A new operating model that supports integrated processes, inventory visibility, and compliance in manufacturing and distribution of clinical trials supplies became a priority. These fundamental improvements are seen as key to the growth of pharmaceutical and biotechnology companies. Infosys Lodestone Lodestone Management finds Consultants that transforming finds that processes transforming and implementing processes and implementing a Clinical Supply a Clinical Chain Supply based Chain based on best on practices best practices leads leads to significant to significant improvements in efficiency in efficiency and effectiveness. and 3
Clinical Trials Supply Management The clinical development phase is the longest and most expensive part of bringing a new drug or medical device to market. Efficient management of clinical study supplies across the supply chain along with precise planning and coordination of activities, both within and outside the organization, are key to successfully conducting clinical studies. Chemical Pilot Plant Formulation Packaging Site A Regional Depot 1 Intermediate Depot Clinical Site Investigator Biotech Bulk Plant Formulation & Filling Packaging Site B Regional Depot 2 Patients This paper examines the key challenges of Clinical Trial Supply Management and explores the potential solutions available. 4
Challenges Three distinct parts of the Clinical Trials Supply Management Process Clinical Forecasting & Planning, Manufacturing, and Distribution pose significant challenges. Clinical Forecasting & Planning Many years before a trial begins, calculations must be made: how much of the new investigational medical drug is required for a patient group across the length of clinical development program? For short term planning, basic formulas, the number of investigative sites x the number of patients per site x dosage x the duration, can be used to provide a study forecast. However, when the trial begins, a range of factors inevitably alter these original forecasts and impact planning. Three key factors include: Patient recruitment Patient recruitment will vary at, and across, various investigative sites due to a number of factors including: patient availability, patient drop outs, study extensions, investigator performance etc. This results in staggered enrollment and fluctuations in demand over the length of the clinical trial. Expiration dating Expiration dating also has an impact on planning and supply management. In many cases clinical supplies must be manufactured prior to the availability of long-term stability data. Delays and/or low enrollment can result in the clinical supplies expiring during the course of the trial. This may subsequently require medications to be relabeled or discarded, requiring the manufacture of replacement materials. Integration across all manufacturing steps A specific plan, at the right level, is required for Bio/Chemical Manufacturing, Pharmaceutical Manufacturing and Clinical Packaging. The key challenge is the ability to keep these plans integrated and aligned. These factors, among others, pose significant challenges to the organization and its ability to conduct accurate forecasting and planning. Chemical/Biotech Production, Pharmaceutical Production & Packaging The production of clinical supplies in many ways mirrors the manufacturing of commercial drugs. For instance, all operations and processes must be fully compliant with current Good Manufacturing Processes (cgmps), and are subject to audit by regulatory agencies such as the US Food and Drug Administration (FDA). However, clinical manufacturing faces a number of distinct challenges, including: Inadequate production or supply of active pharmaceutical ingredients (API) or biotech bulk Shortening of expiration date due to lack of long-term stability data Necessity to package small product lots Manufacture of different dosages and placebos Blinded studies require medications and packaging to appear identical Distribution Compliant shipments of the drugs to many investigational sites, often in different countries, can be difficult to achieve as there is a need for: Adherence to Good Clinical Practices (GCP) and cgmp regulations End to end tracking of the drug throughout the value chain Reliable and efficient accountability processes so that drugs are reconciled, returned, and destroyed appropriately Access to inventory at distribution sites for distribution planning Sharing information with I(W)VRS partners (Interactive (Web) Voice Response System) Investigator site stock control in order to achieve end to end distribution planning Developing a Supply Chain Strategy that addresses challenges posed in forecasting & planning, manufacturing and distribution is critical. Any disruption to the end to end supply of clinical trial materials can have significant impacts on the success of a clinical study. Delays in shipments or stock outs can lead to patient disqualification, damage to investigator relationships, delays in trial completion; potentially the entire study could be jeopardized. 5
How SAP Technology can Help SAP has a wider scope and is more integrated than the best of breed systems. Extending the SAP footprint to include CTSM means that the entire supply chain is now run on the same environment and allows for full integration and adoption of company and industry best practices. Specific SAP technology can significantly enhance and improve the processes for forecasting & planning, manufacturing and distribution of clinical trial supplies. Standard SAP processes for Life Sciences companies can be leveraged to a certain extent and can help to enforce Supply Chain thinking e.g., packaging and distribution should not be isolated processes as is the case at many organizations. However specific SAP clinical trials supply management functionality is still required to create a complete solution: STD SAP Implementation Supply Chain Planning Bio/Chemical Packaging Pharmaceutical Manufacturing Packaging Warehousing SAP Clinical Trials Supply Chain Implementation Batch Management for booklets with country level restriction Randomized number on each kit Long/Medium and Short term Clinical Forecasting Multi step treatment packaging for blinded studies Warehousing for serialized kits in Packaging and Depots Labeling template design on study level and print for serialized kit SAP Clinical Trials Automation Electronic Signatures Barcode scanning of material flow in Packaging Cold Chain Control Pre-requisites Required to achieve next levels but not enough on itself Clinical Trial Specifics in SAP Performance Improvements Leveraging Supply Chain best practices and more Clinical Trials Specific Automations Increasing automation level facilitating innovation to increase competitive advantage An SAP system with processes based on supply chain best practices and enhanced to handle the intricacies of clinical trials will increase the effectiveness and efficiency of the clinical trial organization resulting in reduced time to market, shortened study time lines and reduced R&D costs. 6
Clinical Forecasting & Planning Demand calculation functionality helps with the initial forecasting and subsequent planning processes. Long/medium term clinical forecasting should drive drug substance and/or drug product level plans for a Make-to-Stock strategy. For the short term, the demand forecast should be developed at each distribution point that is supplying to investigators. Material requirements planning (MRP) functionality allows for different planning horizons. Long term plans are required for chemical and biotech bulk plant, medium term plans are required for pharmaceutical production. For the short term horizon, the MRP is improving the call off timing of drug product for packaging sites. Rough-cut capacity planning helps maintain manufacturing capacity, and provides visibility of potential date and material shortfalls. What-if analysis A new demand needs to be analyzed for a certain supply situation. A new version of the demand is created and its impact on supply is compared to the active demand version. Integration of demand planning into cost planning Medium/long term demand information provides the ability to calculate and consolidate the costs in clinical manufacturing in order to support make/buy decisions. Safety-stock planning functionality can be used to ensure reasonable availability levels. Any last-minute demand changes are updated in the planning process. Distribution requirements planning functionality helps the Global Supply Chain Planner make adjustments during distribution planning: they can evaluate study-based demand requirements, taking into account the on-hand inventory, to provide the net study requirement. The output will be planned orders for packaging, purchase requisitions for to-be-purchased items, and a plan for just in time distribution of the study materials to the receiving network. The commitment of planned packaging orders must take place in time to meet the most recent demand placed at the distribution point. This commitment to planned demand supports also just-in-time (JIT) packaging and labeling of product to increase the flexibility in the supply chain. Batch allocation functionality covers the allocation of batches to process orders in every production step. Enhanced batch allocation functionality is typically required in clinical trials due to regulatory, country and shelf live restrictions. Randomization tools allow you to create medication numbers according to state-of-the-art statistical algorithms. A randomization manager incorporates the externally generated randomization data in the process orders. Labeling management allows the design of label templates that can be used for a study and/or a participating country. The label printing needs to be integrated with process order handling. The labels need to be printed for serialized materials or for batch materials before packaging operations are started. Warehousing and Distribution Batch search and determination functionality covers the semiautomatic and automatic selection of batches for shipping. Multi level warehouse management and shipping driven by consignment requests for serialized kits is requiring highly automated process controls to avoid errors in picking of multi level kits. General E-records and E-signatures meeting regulatory requirements are supported and will become more important in the future. Inventory management provides a structured inventory backbone for registering all chemical/biotech and pharmaceutical production, packaging and distribution stocks across the network. The current SAP solution suite can enable the clinical trials supply chain in a unique way. There is no other best of breed system to enable an end to end supply chain management. Chemical/Biotech Production, Pharmaceutical Production and Packaging Process order handling on the shop floor supports good manufacturing practices. Shop floor data collection systems, using barcode scanning devices, help manage the execution of manufacturing, packaging, labeling and shipping activities to automate traceability. 7
SAP Alone is Not the Solution A solid foundation ensures maximum impact of your SAP technology. However, systems alone are not the solution. Several critical success factors must be managed from a very early stage in the project. Benefits Realization and Road Mapping Organizations must first analyze their current situation and define their business priorities for clinical trials: Improve inventory visibility? Which materials? Also downstream distribution? Reduce material overage? Benefits realization and road mapping Leverage CTSM best practice knowledge Clinical Trials Supply organizational alignment Replace a legacy system as it is falling apart or the system is not validated? Leverage our current SAP landscape and support organization? In-sourcing of packaging or distribution? New regulatory requirements? Minimize risk of recalls? New cold chain requirements? Increase efficiency? Beyond building a business case for investment approval, this activity provides fundamental insights for the business into the program, promotes a change in current thinking and provides a reference point for all stakeholders throughout the life cycle of the project. The business case must clearly identify the benefits and establish related performance measures. In establishing performance measures the organization creates the basis for monitoring continuous improvement. The business case cannot be delivered in one phase as the transformational change may be too dramatic. A road map phasing the benefits of realization will be critical to the success of the company journey. 8
Leverage CTSM Best Practice Knowledge in the to be Process Design The project starting activities need to be carefully planned. As there are no off-the-shelf solutions for the complex or integration requirements in Clinical Trials Supply Management, a proof of concept phase is the preferred approach to suggest solutions for the complex and specific clinical trials processes. People confuse a prototyping approach with a proof of concept approach. A prototype is a system prepared with master data by technical people, the user presentation tends to focus on isolated units of information processing or automation. Business people usually get lost trying to understand the process innovation and clinical trial best practices. A proof of concept starts from a holistic view on the Clinical Trials Supply Management solution. The end-to-end process are presented by demonstrating pre-configured modules supported with Powerpoint to clarify any missing soft-ware components. This approach increases business buy-in and allows Technical Development departments to begin to re-think the manufacturing and supply chain management. Ensure Clinical Trials Supply Organizational Alignment The implementation of new processes can transform the business and significantly impact many functions: Demand Planning, Materials Planning, Clinical Trial Packaging, Chemical or Biotech Pilot plant, Pharmaceutical Production, Subcontractors, Distribution, IV(W)RS Service Providers, etc. It is imperative that these new processes be formalized as written procedures which include roles and responsibilities. This information must be clearly communicated to the organization with training provided on new responsibilities and procedures. Life Sciences companies must recognize that their Technical Development personal were initially recruited to add scientific value and to innovate new products. Generally their current career development plans have not included a track for gaining expertise in lean clinical trials manufacturing or demand & inventory planning best practices. Planning and execution of learning activities integrated with above design tasks is critical to guide the project and end-user community into the new CTSM vision. The reinforcement and understanding of CTSM best practices needs to be a coordinated effort throughout the project, espe- cially during the process definition phase. Best practices lever- aged by Infosys Lodestone Lodestone proprietary proprietary CTSM add-ons CTSM add-ons are key are inputs key into inputs the into detailed the detailed process process design. design. People must also be clear on the best practice concepts of globally harmonized and integrated system environments. A thorough understanding of the new process and its benefits will help ensure a successful implementation and increase user acceptance. 9
Conclusions and Recommendations A significant opportunity exists for Life Sciences companies to improve the efficiency and cost effectiveness of their clinical trail supply chains. In the most successful cases, companies have started with a solid foundation including a clear vision and a solid business case. They have introduced a comprehensive program based on SAP technology, and supported by a change management program and organizational transformation. An SAP system with processes based on supply chain best practices and enhanced to handle the intricacies of clinical trials will increase the effectiveness and efficiency of the clinical trial organization resulting in reduced time to market, shortened study timelines and reduced R&D costs. 10
Authors Geert Crauwels, Partner, Switzerland Before working as a consultant, Geert gained a broad experience in the Electronics and Machine industry in supply chain functions and was responsible for various change and performance improvement projects in an international context. Geert has 13 years consulting experience, mainly in supply chain management projects in logistics centers, manufacturing plants and distribution. Geert is focusing both on innovative Life Sciences SAP projects and on Operational Strategy projects. Frank Leinenbach, Managing Consultant, Romania Frank has 9 years of consulting experience for multinational companies, mainly in in the area of of Life Sciences. He is an experienced team leader and supply chain consultant, specialised in in Production Planning and Execution. He has deep expertise in integrated functions like Batch management and Master data management as as well well as as 21CFR 21CFR Part Part 11. 11. Frank Frank was was one one of the of the Lodestone Infosys Lodestone architects driving architects the innovative driving the design innovative of new design Clinical of new Trials Clinical Supply Trials Management Supply Management functionality functionality for SAP. for SAP. Jim Williams, Associate Partner, United States Jim has 19 years of IT experience and has held leadership positions in consulting, industry and as an entrepreneur. Jim began his consulting career working at Andersen Consulting and Pricewaterhouse and worked for numerous fortune 500 clients. He has 14 years of global SAP experience working in supply chain and project management. Lodestone is a global management consultancy, committed to designing and delivering solutions that enable companies to thrive in today s complex business environment. Founded in 2005, Lodestone has grown to more than 800 employees in 17 countries on five continents. In 2011 Lodestone generated revenue of over 207 Million Swiss francs. About Infosys Lodestone Lodestone has developed significant experience and expertise in Clinical Trial Supply Management from strategy to implementation. SAP add-ons for CTSM have been developed by Lodestone Infosys Lodestone, a fully owned subsidiary of Infosys, is a management consulting firm advising international companies on strategy and process optimization as well as IT-enabled transformation. Adopting a value-integration approach, Infosys Lodestone in order to accelerate implementations. is focused on a value-adding combination of management and IT consulting. The firm, with its 1200 employees in 17 countries on five continents, delivers consulting services primarily geared to the life science, chemical and financial services industries as well as the investment, automotive and consumer goods sectors. 11
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