SPPM Clinical 7 Best Practices In Forecasting & Planning

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Strategic Project Portfolio Management for Clinical Trials

Ø Plan clinical trial expenditure using a top-down approach based on empirical or historical data

Ø Adjust the plan bottom-up after assessing individual site and region enrolment plan

Ø Update the plan using actual study performance data

Ø Manage accruals and payments

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  • SPPM Clinical 7 Best Practices In Forecasting & Planning

    1. 1. SPPM Clinical Strategic Project Portfolio Management for Clinical Trials 7 Best Practices for Forecasting and Planning Wolfgang Roesch, Head of Global Sales
    2. 2. Agenda <ul><li>Cubus in Brief </li></ul><ul><li>SPPM Clinical – The Concept </li></ul><ul><li>Technical and Functional Overview </li></ul><ul><li>Best Practices </li></ul><ul><li>Summary </li></ul>
    3. 3. Cubus and Triumph Consulting Partnership Joint Expertise for Managing Clinical Trials
    4. 4. A selection of our customers
    5. 5. SPPM Clinical Strategic Project Portfolio Management for Clinical Trials The Concept
    6. 6. Clinical Trials is Part of a Broader Picture <ul><li>Bridging the gap between R&D and commercial interests The central challenge is to ensure that the right new products get developed efficiently with minimum risk and maximum value – to allow senior management to make smart decisions confidently. </li></ul>“… with pressure on all stakeholders in the pharma industry and the few new drugs that came to the market in recent years, NPP should take on more and more importance in driving what projects to dedicate resources to…” Copyright © Best Practices ® LLC
    7. 7. Project Portfolio Management Develop. Phase 1 Phase 2 Phase 3 Launch Archive Deploy Retire Observation Patent Maintenance Obsolescence Production Licensing Maintenance Revisions Disposal Option Value Cash Flow Value License out License in Ideas
    8. 8. Clinical Trials Financial Managment <ul><li>Planning clinical trial expenditure using a top-down approach based on empirical or historical data </li></ul><ul><li>Adjusting the plan buttom-up after assessing individual site and region enrollment plan </li></ul><ul><li>Updating the plan using actual study performance data </li></ul><ul><li>Track activities to manage accruals and payments </li></ul>Clinical Trial Performance Target Forecast Track Analyze Financial Report Align / Close
    9. 9. The Process Portfolio Mgmt Study Planning Feasibility (Region) Feasibility (Site) Study Startup Do I run a study? What are my key milestones? Does my region have capacity? Has site been chosen ? What are my targets ? Is my study on track ? Do I need to re-plan ? Study Runs High level project info – product, program, study Information may go into CTMS (e.g. Siebel) Study setup - key phase milestones, patterns Information may go into CTMS (e.g. Siebel) Region setup – regional capacity planning Decision: insourced or outsourced Information may go into CTMS (e.g. Siebel) Site creation & setup Information may come from CTMS (e.g. Siebel) Forecast: timelines, costs, resources, recruitments Information may go into CTMS (e.g. Siebel) actuals Information may come from CTMS (e.g. Siebel)
    10. 10. SPPM Clinical Strategic Project Portfolio Management for Clinical Trials Best Practices
    11. 11. Planning and Forecasting Paradigms <ul><li>Level of details depends on time scale. As more as you go back into history or into future, the less detail is relevant </li></ul><ul><li>General rule: the time between two updates of the plan resp. f/c should be the time frame that you do plan </li></ul><ul><li>Avoid duplicate data entry, build automated interfaces to source systems </li></ul><ul><li>Users (keying in data) need to be responsible for the results, otherwise data quality will suffer. If changes are needed, create feedback loops. </li></ul>
    12. 12. # 1 Best Practice: Single Version of the Truth Store all data in a central place, not locally on individual’s PCs. Be sure to have one version of the truth Features: Portfolio View, Program Overview, Gantt Charts
    13. 13. # 2 Best Practice: User Responsibility Users (keying in data) need to be responsible for the result, otherwise will end up with bad data quality. Users also ought to have immediate access to results. When keying in data, he should have access to the results produced by any type of calculation (e.g. reports). Features: Easy Input Templates, Excel Look Alike, User-friendly Interfaces
    14. 14. # 3 Best Practice: Right Level of Detail Too much detail reduces, too little detail does not produce quality. If you have more detail in plan than what can be reported as actual, quality of plan suffers (monitoring plan vs. f/c) Features: Reduced on-Screen Information, Advanced Activity Tracking
    15. 15. # 4 Best Practice: Scenario Simulations Work with Simulations (value simulations or structure simulation) Simulation need modelling, i.e. definition of input values, definition of calculations, definition of resulting values (example: (# of patients) * (# of visits) * (cost per visit) = total visit costs) The more detail, the more sophisticated model has to be, otherwise there will be a big number of inputs (complexity then has to be handled by user) Features: Multiple Scenarios, Enhanced Ad-Hoc Analysis and Reports
    16. 16. # 5 Best Practice: No Magic Numbers Don’t create “magic numbers”; Calculations always need to be understandable by end-user (how is result calculated, e.g. cost per visit, enrollment status) Features: Transparent Multiple Treatment Arms, Patient Enrollment Graphs
    17. 17. # 6 Best Practice: Workflow and Process Support Features: Workflow emails and Alerts Users should have ability to “submit” (“I’m ready”) his data – equally to sending an Excel-sheet by email. Notifications to users that
    18. 18. # 7 Best Practice: Build a History Features: Historic information, Versioning, Graphical Presentation Monitor your planning quality by building a history, and be able to compare plan to plan, plan to f/c and actual to plan.
    19. 19. Top Down - Create Feedback Loops Portfolio Mgmt Study Planning Feasibility (Region) Feasibility (Site) Study Startup High level project info – product, program, study Study setup - key phase milestones, patterns Region setup – regional capacity planning Site creation & setup Forecast: timelines, costs, resources, recruitments Study Runs Raw budget High level budget Vendor level budget Protocol level budget Country level budget actuals
    20. 20. Bottom Up and Actuals Portfolio Mgmt Study Planning Feasibility (Region) Feasibility (Site) Study Startup High level project info – product, program, study Study setup - key phase milestones, patterns Region setup – regional capacity planning Site creation & setup Forecast: timelines, costs, resources, recruitments Study Runs Raw budget High level budget Vendor level budget Protocol level budget Country level budget actuals
    21. 21. Here it becomes tricky… Forecast: timelines, costs, resources, recruitments actuals Raw budget High level budget Vendor level budget Protocol level budget Country level budget Will forecast for the remainder of protocol be based on plan? Or on last forecast? Will it be based on trends or on originally anticipated targets? Remainder calculated based on individual patient visit status. If enrollment is behind plan, is target still achievable? Will this involve additional vendors / costs? Do you have an overview across all other programs? Will these be affected by the changes? Do you still have information about the orginal plan? Can you identify typical and repeating failures?
    22. 22. CPPM Clinical <ul><li>Best Practices for Flexible Forecasting and Planning </li></ul><ul><ul><li>Top-Down and Bottom-Up </li></ul></ul><ul><ul><li>Assumptions driven </li></ul></ul><ul><ul><li>Activity based </li></ul></ul><ul><li>Tracking capabilities </li></ul><ul><li>Multi-currency support </li></ul><ul><li>Enhanced Reporting for “better meet needs” Reports </li></ul><ul><ul><li>AdHoc analysis </li></ul></ul><ul><ul><li>Audit trail </li></ul></ul><ul><ul><li>Comparisons across protocols </li></ul></ul><ul><li>Flexible workflow setting triggers and alerts </li></ul><ul><li>Highly flexible framework allows deploying modules on all levels </li></ul><ul><li>Tight data integration with Oracle Siebel CTMS </li></ul>Update Adjust Track Plan
    23. 23. Transparent, Predictable and Aligned Key Benefits <ul><li>Pre-packaged modular Solution helps to reduce budgeting and planning cycles by weeks or months </li></ul><ul><li>Better Information quality therefore detailed justification for resource requests (FTE and budget) </li></ul><ul><li>Integrates financial and operational planning in one system for better tracking and transparency </li></ul><ul><li>Supports advanced, power-user modelling capabilities with seamless Microsoft Excel integration </li></ul><ul><li>Appeals to a wider user community through a simplified Web user interface </li></ul><ul><li>Adds quick-to-implement and fully-supported functional solutions </li></ul><ul><li>Meets industry-specific needs by leveraging industry expertise </li></ul><ul><li>Enables rapid discovery of trends and highlights in large data sets </li></ul><ul><li>Ability to utilize from legacy system and leverages investments of those </li></ul><ul><li>Ensures accurate budgets and forecasts </li></ul>
    24. 24. Architecture Application Oracle 10x Essbase RDBMS Data Sources OLAP SPPM-XML Built-in ETL Excel Web Reporting Cubus CTMS Cubus CTMS Business Applications (CTMS / Others) File Systems & Spreadsheets Data Warehouse Data Mart OLAP Others
    25. 25. One Application – Multiple Cubes CTMS Planning Currency Rates CTMS Actual & Forecasts Reporting Rates & Treatment Patterns <ul><li>Potential Dimensions: </li></ul><ul><li>organisational structure </li></ul><ul><li>protocol structure </li></ul><ul><li>scenarios </li></ul><ul><li>time (years, quarters, months, weeks, days) </li></ul><ul><li>performance indicators </li></ul><ul><li>visits </li></ul><ul><li>investigators </li></ul><ul><li>patients </li></ul><ul><li>products </li></ul><ul><li>… </li></ul>
    26. 26. Summary <ul><li>Links targets to operational decisions </li></ul><ul><li>Integrates clinical trial processes </li></ul><ul><li>Delivers consistent, reliable insights to optimize processes and costs </li></ul><ul><li>Lowers costs and reduces system complexity </li></ul><ul><li>Single version of the truth </li></ul>Clinical Trial Performance Target Forecast Track Analyze Financial Report Align / Close
    27. 27. Contact for further information: <ul><li>Wolfgang Roesch, Head of Global Sales, Cubus AG </li></ul><ul><ul><li>Email [email_address] </li></ul></ul><ul><ul><li>Phone +49 7032 9451 0 </li></ul></ul><ul><ul><li>Mobile +49 1637 9451 38 </li></ul></ul>

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