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

1. SPPM Clinical Strategic Project Portfolio Management for Clinical Trials 7 Best Practices for Forecasting and Planning Wolfgang Roesch, Head of Global Sales

3. Cubus and Triumph Consulting Partnership Joint Expertise for Managing Clinical Trials

4. A selection of our customers

5. SPPM Clinical Strategic Project Portfolio Management for Clinical Trials The Concept

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

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. SPPM Clinical Strategic Project Portfolio Management for Clinical Trials Best Practices

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. # 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. # 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. # 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. # 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. # 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. # 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. 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. 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. 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?

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