SPPM Clinical 7 Best Practices In Forecasting & Planning

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


Cubus and Triumph Consulting PartnershipJoint Expertise for Managing Clinical Trials


SPPM ClinicalStrategic Project Portfolio Management

for Clinical Trials

The Concept


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


Develop. Phase 1 Phase 2 Phase 3

Launch

Archive

DeployRetire

ObservationPatentMaintenanceObsolescence

ProductionLicensing

MaintenanceRevisions

DisposalOption Value

Cash Flow Value

Licenseout

Licensein

Ideas

Project Portfolio Management


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


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)


SPPM ClinicalStrategic Project Portfolio Management

for Clinical Trials

Best Practices


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.


# 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


# 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


# 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


# 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


# 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


# 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


# 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.


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


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


StudyRuns

Raw budget

High level budget

Vendor level budget



actuals


Here it becomes tricky…


actuals

Raw budget

High level budget

Vendor 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?


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


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


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


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• …


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


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

SPPM Clinical 7 Best Practices In Forecasting & Planning

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