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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 ClinicalStrategic Project Portfolio Management for
Clinical Trials
7 Best Practices forForecasting and Planning
Wolfgang Roesch, Head of Global Sales
Sales & Marketing Meeting 2009-02-16 Folie 2
Agenda
• Cubus in Brief
• SPPM Clinical – The Concept
• Technical and Functional Overview
• Best Practices
• Summary
Sales & Marketing Meeting 2009-02-16 Folie 3
Cubus and Triumph Consulting PartnershipJoint Expertise for Managing Clinical Trials
Sales & Marketing Meeting 2009-02-16 Folie 5
SPPM ClinicalStrategic Project Portfolio Management
for Clinical Trials
The Concept
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Clinical Trials is Part of a Broader Picture
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.
“…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
Sales & Marketing Meeting 2009-02-16 Folie 7
Develop. Phase 1 Phase 2 Phase 3
Launch
Archive
DeployRetire
ObservationPatentMaintenanceObsolescence
ProductionLicensing
MaintenanceRevisions
DisposalOption Value
Cash Flow Value
Licenseout
Licensein
Ideas
Project Portfolio Management
Sales & Marketing Meeting 2009-02-16 Folie 8
Clinical
Trial
Performance
Target
Forecast
Track
Analyze
Financial
Report
Align /
Close
Clinical Trials Financial Managment
Planning clinical trial expenditure using a top-down approach based on empirical or historical data
Adjusting the plan buttom-up after assessing individual site and region enrollment plan
Updating the plan using actual study performance data
Track activities to manage accruals and payments
Sales & Marketing Meeting 2009-02-16 Folie 9
The Process
PortfolioMgmt
StudyPlanning
Feasibility(Region)
Feasibility(Site)
StudyStartup
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 ?StudyRuns
High level project info – product, program, studyInformation may go into CTMS (e.g. Siebel)
Study setup - key phase milestones, patternsInformation may go into CTMS (e.g. Siebel)
Region setup – regional capacity planningDecision: insourced or outsourced
Information may go into CTMS (e.g. Siebel)
Site creation & setupInformation may come from CTMS (e.g. Siebel)
Forecast: timelines, costs, resources, recruitmentsInformation may go into CTMS (e.g. Siebel)
actualsInformation may come from CTMS (e.g. Siebel)
Sales & Marketing Meeting 2009-02-16 Folie 10
SPPM ClinicalStrategic Project Portfolio Management
for Clinical Trials
Best Practices
Sales & Marketing Meeting 2009-02-16 Folie 11
Planning and Forecasting Paradigms
Level of details depends on time scale. As more as you go back into history or into future, the less detail is relevant
General rule: the time between two updates of the plan resp. f/c should be the time frame that you do plan
Avoid duplicate data entry, build automated interfaces to source systems Users (keying in data) need to be responsible for the results, otherwise
data quality will suffer. If changes are needed, create feedback loops.
Sales & Marketing Meeting 2009-02-16 Folie 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
Sales & Marketing Meeting 2009-02-16 Folie 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
Sales & Marketing Meeting 2009-02-16 Folie 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
Sales & Marketing Meeting 2009-02-16 Folie 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
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# 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
Sales & Marketing Meeting 2009-02-16 Folie 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
Sales & Marketing Meeting 2009-02-16 Folie 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.
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Top Down - Create Feedback Loops
PortfolioMgmt
StudyPlanning
Feasibility(Region)
Feasibility(Site)
StudyStartup
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
StudyRuns
Raw budget
High level budget
Vendor level budget
Protocol level budget
Country level budget
actuals
Sales & Marketing Meeting 2009-02-16 Folie 20
Bottom Up and Actuals
PortfolioMgmt
StudyPlanning
Feasibility(Region)
Feasibility(Site)
StudyStartup
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
StudyRuns
Raw budget
High level budget
Vendor level budget
Protocol level budget
Country level budget
actuals
Sales & Marketing Meeting 2009-02-16 Folie 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?
Sales & Marketing Meeting 2009-02-16 Folie 22
CPPM Clinical
Best Practices for Flexible Forecasting and Planning Top-Down and Bottom-Up Assumptions driven Activity based
Tracking capabilities Multi-currency support Enhanced Reporting for “better meet needs” Reports
AdHoc analysis Audit trail Comparisons across protocols
Flexible workflow setting triggers and alerts Highly flexible framework allows deploying modules on all levels Tight data integration with Oracle Siebel CTMS
UpdateAdjust TrackPlan
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Transparent, Predictable and AlignedKey Benefits
Pre-packaged modular Solution helps to reduce budgeting and planning cycles by weeks or months
Better Information quality therefore detailed justification for resource requests (FTE and budget)
Integrates financial and operational planning in one system for better tracking and transparency
Supports advanced, power-user modelling capabilities with seamless Microsoft Excel integration
Appeals to a wider user community through a simplified Web user interface
Adds quick-to-implement and fully-supported functional solutions
Meets industry-specific needs by leveraging industry expertise
Enables rapid discovery of trends and highlights in large data sets
Ability to utilize from legacy system and leverages investments of those
Ensures accurate budgets and forecasts
Sales & Marketing Meeting 2009-02-16 Folie 24
Application Oracle 10xEssbase RDBMS
Data Sources
Architecture
OLAP
SPPM-XML Built-in ETL
Excel Web ReportingCubus CTMS
Cubus CTMS
BusinessApplications
(CTMS / Others)
File Systems &Spreadsheets
Data WarehouseData Mart
OLAPOthers
Sales & Marketing Meeting 2009-02-16 Folie 25
One Application – Multiple Cubes
CTMS PlanningCTMS Planning
Currency Rates
Currency Rates
CTMS Actual & Forecasts
CTMS Actual & Forecasts
ReportingReporting
Rates & Treatment
Patterns
Rates & Treatment
Patterns
Potential Dimensions:• organisational structure• protocol structure• scenarios• time (years, quarters, months, weeks, days)• performance indicators• visits• investigators• patients• products• …
Sales & Marketing Meeting 2009-02-16 Folie 26
Clinical
Trial
Performance
Target
Forecast
Track
Analyze
Financial
Report
Align /
Close
Summary
Links targets to
operational decisions
Integrates clinical trial
processes
Delivers consistent, reliable
insights to optimize processes
and costs
Lowers costs and reduces
system complexity
Single version of the truth
Sales & Marketing Meeting 2009-02-16 Folie 27
Contact for further information:
Wolfgang Roesch, Head of Global Sales, Cubus AG Email [email protected] Phone +49 7032 9451 0 Mobile +49 1637 9451 38