planisware 5 for pharmaceutical organizations - · pdf filedynamic reporting capabilities...

PLANISWARE 5 FOR PHARMACEUTICAL ORGANIZATIONS

Planisware 5for Pharmaceutical Organizations

Overview

Streamline your company’s project, resource, and portfolio management processes with Planisware’s fully inte-grated, web-based solutions. Gain a clear global project view, increase productivity, optimize resource utiliza-tion, accelerate time-to-market... and improve your bottom line!

Pharmaceutical companies are multi-layered organizations with strategic portfolio initiatives, cross-functional directives and distinct operational goals. Amidst a complex environment, governing bodies must find a way to measure portfolio execu-tion and translate corporate strategy into portfolio targets and project decisions. As functions work to complete their own objectives, Project and Resource Managers require cooperation across business units to successfully deliver projects and programs. Meanwhile, moving pieces make it difficult for Resource Managers to address issues of resource capacity and challenge Project Managers to synchronize work efforts, consolidate disjointed data, respond efficiently to regulatory requirements and critical activities, and quantify the impact of project decisions. These obstacles highlight how important it is for pharmaceutical companies to employ the right Project Portfolio Manage-ment (PPM) solution. Planisware is the comprehensive, integrated planning solution 11 of the top 12 pharmaceutical companies worldwide turn to in order to provide the visibility needed for better-informed, faster governance; to enable the transparency required to improve time-to-market; and to foster collaboration across the organization.

Whether your organization requires a small-scale, department-centric tool or a full cross-enterprise solution, Planisware 5 offers functionality and flexibility designed to facilitate successful planning for pharmaceutical organizations!

The Planisware AdvantageA Fully Integrated Solution Planisware’s comprehensive all-in-one solution encompasses the full life cycle of program and project development pro-cesses from strategic portfolio management, to project, resource and cost management, to operational and collaboration processes. Planisware’s wide reach of functionality supports sales and marketing, research, clinical operations, regulatory and manufacturing groups alike. Built around a single enterprise database and platform, Planisware ensures global availabil-ity of project information, and real-time data consolidation for optimal transparency. A fully web-enabled solution, Planisware is role-based, making it easy for all end users to use regardless of level of involvement in the tool.

Proven Implementation Methodology, Quality Consultants Planisware’s expert consultants utilize the our own agile-inspired FlexPace methodology to efficiently tailor the system to fit organization-specific requirements, processes, and workflows through iterative workshops and a consistent feedback loop. The dedication put forth by our team of consultants has been repeatedly cited by our customers. A Leader in the Pharmaceutical Industry Our extensive presence in the pharmaceutical community has cultivated an active user community! Customer-initiated, customer-driven user groups convene regularly to share best practices and tips concerning the tool, and related PPM rel-evant processes. Years of collaboration with top pharmaceutical companies have provided Planisware with a background in industry best practices and has influenced the system’s screens, reports and workflows - resulting in a solution that delivers immediate value and return.

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PLANISWARE 5

The Planisware SolutionFunctionality-rich Planisware comes equipped with built-in business processes geared toward solving problems faced in the pharmaceutical industry - and also offers the flexibility to adjust to the way you work. The subsequent pages in this brochure highlight the most popular capabilities that benefit our customers in the pharmaceutical industry. Planisware’s renowned flex-ibility allows each piece of functionality to be activated or deactivated to best suit the needs of each customer.

The following capabilities are included in this document:

• Integrated Project Planning (p.4) - Learn how users from different functions and roles can work together harmoniously on the same project.

• Portfolio Management (p.5) - Gain a cross-project view of key metrics to track the performance of your portfolio and enable meaningful portfolio analysis.

• Project Management (p.6) - Manage project sched-ules with the right combination of basic or advanced features that aligns with your organization’s PPM requirements and maturity level.

• Operational Planning (p.7) - Enable particular func-tions to take advantage of features specifically benefi-cial for their business.

• Resource Management (pp.8-9) - Manage resources through Planisware’s Resource estimation, Resource Capacity Management, Resource Allocation and Time Tracking capabilities.

• What-If Analysis (p.10) - Assess the impact of proj-ect changes at the study, project, or portfolio level in a sandbox environment before enacting the changes permanently.

• Risk Management (p.10) - Explore a variety of methods that can be used to account for risk in your projects.

• Collaboration (p.11) - Empower project team mem-bers to communicate effectively with each other using built-in collaboration workflows.

• Integration with External Systems (p.11) - Integrate with other established systems to streamline cross-system processes and gain a broader perspective.

The list above is not exhaustive of the features available in Planisware. If you are interested in a feature which is not in-cluded in this list, please browse our website at www.planiware.com, or call 888-752-6479 for more information.

•EasytouseRole-BasedWebUserInterface

•BuiltinPharmaBestPractices

•IntegratedProgram&ProjectManagement

•ResourcePlanning&Tracking

•PredictiveAlgorithms

•KeyPerformanceIndicators/Metrics

•CollaborationWorkflows

•PortfolioManagementCapabilities

•ComprehensiveReportingFunctionality

•Seamless integration with

other business systems

•AWorldClassImplementationTeam

Key Benefits of Planisware 5 for Pharmaceutical Organizations

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Fully Integrated Planning Multi-Level Planning For pharmaceutical organizations, it is important for project teams to have visibility to the latest dates planned by opera-tions, understand the impact of schedule changes and control the schedule reported to management. Planisware supports bi-directional communication between project teams and operations so that project teams can inform operations of project targets in the long term, and operations can supply project teams with the latest thinking dates during the detailed planning phase.

With this multi-level approach, communication is real-time, powered by transparency, but project teams can maintain control of what is presented to management.

A Matrix Environment for Matrix Organizations

In addition to top-down and bottom-up communication, Planisware is also equipped to deal with parallel planning initiatives. A built-in matrix-based project design enables projects to be partitioned into work packages, and delegated to be worked on by different functions or team members. Userscanthengainquickaccesstodelegated activities for a given project; or across projects; and to full project views.

With integrated project plans, individuals working on a given project have a single, unified view of the truth. Meanwhile, project teams gain the cross-functional perspective needed to understand the impact of a change across functions. This design frees functions to focus on relevant work while cross-project viewing capabilities facilitate work across multiple projects. The flexibility of the solution enables different levels of the organization to work at their appropriate level of detail, while ensuring maximum transparency, visibility and control.

Figure 1: Planisware’s multi-level planning capabilities enable top-down and bottom-up transpar-ency and communication.

Planisware 5

CrossFunctionalLevel

FunctionalLevel

Key milestones

Functional details withassociated milestones

Pre-Clin PHI PHII PHIII PHIV Prod/Mkt

Figure 2: In a project organization matrix, each row represents a project and each column represents a function that can work in each project. Select rows to view entire projects. Highlight columns to view the activities for selected func-tions across all projects. Select cells to view specific cross-sections of projects and functions.

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Portfolio ReportingReporting in Planisware can be as flexible or rigid as your organization needs it to be. From already-made reports where a user’s only decision is to define the portfolio of projects to display, to the flexible reporting wizard where the user has the ability to define the content, the reporting dimensions, as well as the type and style of a report, Planisware is equipped with reporting capabilities to meet the needs of all types of stakeholders.

Planisware 5 includes the following reporting options to meet your organization’s portfolio management needs:

• Built-in Standard Reports – Planisware 5 comes equipped with canned Portfolio reports addressing timing, resources, financials, risks and general portfolio overviews, providing value for users quickly. The standard set of re-ports include Project Milestone Dates, Project Milestone Date Variance Report, Clinical Milestone Dates, Launch Date byBusinessUnit,ProjectsbyBUandProjectType,FunnelProfile,andCycleTimes.

• Reporting Wizard – When standard reports are not enough, Planisware 5 includes a wizard which empowers users to create new ones. Dynamic reporting capabilities enable advanced users to put together their own Planisware reports and dashboards on the fly by selecting content and settings within the framework of standard report types like bubble charts, pie charts, bar graphs, line curves, etc. All user-created reports can be updated, shared, included in a dash-board, or inserted as new pages within the application.

• Customer-Specific Reports – Planisware consultants and technical administrators can use the authoring tool to create reports built to specification. This is a good option for reports that have already been widely accepted by the organiza-tion, or executive reports that are required to follow a strict structure.

PLANISWARE 5

Apart from its Web-based reporting functionality that can be used by different departments

of our organization worldwide, Planisware Pharma provides our teams with a high-level of

project transparency. All project information is available immediately, which helps us

manage our projects much more effectively.

– Karl-Eric Leyser, Novartis Pharma

“ “

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Figure 3: A Planisware report displays the user-selected list of key milestones for a list of studies.


Complete Project Management Scheduling

As one of the few web applications around with an advanced integrated scheduling engine, Planisware 5 offers a wide array of scheduling capabilities that customers can choose from to adjust the system to the maturity of their organization’s sched-uling practices. Features include:

• Critical path analysis allows users to view the critical path of a project, within a subset of a project, or to a user se-lected milestone.

• Intra and cross-project dependencies, eliminate the need to duplicate milestones, avoiding multiple versions of the truth in an environment where a project often depends on deliverables from other projects,

• Resources and costs are integrated directly with timeline, guaranteeing alignment. Payments can be scheduled with milestones, while work for support functions can automatically extend with their activities.

• Schedules can be quickly assembled from business-specific templates and libraries. Templates and libraries provide project portfolios with a baseline set of standards and allow for the reliable comparison of like projects.

Resource and Cost Estimation

Planisware 5 supports the Earned Value methodology to track costs and measure forward progress - combining scope, schedule, cost and performance into a single methodology. Planisware’s cost management features enable organizations to plan internal costs and supplier costs, while seamless integration with ERPs (e.g. SAP, Peoplesoft) often extend the view to include actual expenses as well.

As an enterprise tool, resource and cost estimations in Planisware 5 are structured in strict accordance to enterprise-wide standards. Forecasts tagged by the company’s centralized definition of work-, resource-, cost account- and organizational-breakdownstructures-ascompliantwithPMBOKmethodologies-enablesubsequentreportingalongthosedimensions.Multi-currency management supports global project management and resource profiles for labor rates convert effort into operational expenses. Such profiles can be defined and updated as needed to reflect current market rates. Moreover, historical rates can be preserved for the time period in which they were effective. For more information about resource and cost estimation tools please refer to p.8.

Budget Control and Progress Tracking

Planisware 5 provides tools to track progress and measure health throughout the project life cycle. A few features designed to help Project Managers control budget and track progress include:

• Project dashboards summarize key metrics in succinct views.

• Historical baselines measure project progress and performance.

• Activity thresholds alert users to noncompliance of governance approved measurements.

• Key performance indicators and trend analysis views provide another measure for the health of each project.

Decision Point Tracking

While drug development projects do not always follow a strict Stage-Gate process, (e.g. Phase II and Phase III may run in parallel), it is often valuable to track the approval of Decision Points or Phases and their associated activities and costs. Take advantage of Planisware’s StageGate-Ready certified workflows to track approved or committed costs. Further, apply-ing attrition rates against decision points enables organizations to incorporate probability of technical success into cost and resource estimations.

Figure 4: The Project Dashboard displays key information about the progress of the given project.

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PLANISWARE 5

Operational PlanningAlthough all project management features are designed for use across the organization, a number of features are particu-larly well-suited for planning at the detailed operational level.

Cross-Functional Visibility

Planisware’s Synchronization Module facilitates com-munication and promotes alignment between operation-al departments and project management by allowing for mutual visibility to each other’s key project milestones.

The comparison is accomplished seamlessly, within the context of the given user’s own project view and can capture both scheduling misalignments, as well as attribute discrepancies (e.g. study drivers).

This means functions like Pre-Clinical, Clinical, Drug Safety, Biometrics, etc. can access targeted milestone dates and Project Management can gain insight into realistic deliveries - before problems occur.

Regulatory Affairs

Careful milestone-tracking and diligent document management assist Regulatory professionals in addressing regulatory compliance and proper submission preparation. Standard or customized reports summarizing key Regulatory milestone dates at the project or portfolio level keep milestone dates in clear view.

Planisware’s Documentation Management capabilities enable users to attach documents to projects or directly against important tasks or milestones, while a flexible directory structure allows users to arrange the documents exactly as they should appear. Alternatively, Planisware customers using Microsoft SharePoint, or other similar content management sys-tems, can manage Planisware documents in the SharePoint repository, or even deploy Planisware modules as SharePoint Web Parts.

Clinical Operations

Customers who use a Clinical Trial Management System (CTMS) to manage the details of clinical tri-als benefit from an interface between Planisware and CTMS. In such integrations, planned information from Planisware is sent to CTMS in the earlier stages of planning and exchanged for actual data from CTMS when the clinical trials occur.

The data imported into Planisware can be used to ex-pedite a variety of processes, including the following:

• Data like “actual number of sites” can replace previously entered study drivers for improved accuracy of FTE estimations and planned clinical trial costs.

• Data like the “actual number of patients enrolled,” can feed reports that help users monitor the progress of patient enrollment.

• Imported “actual start” and “actual finish” dates of key milestones can be used to push the schedule directly.

Figure 6: Implement a Planisware–CTMS interface to send initiated or planned information from Planisware to CTMS and receive actual data and clinical trial details from CTMS.

Planisware

Schedule information

Trial information-Name-Planned dates-Status

Patient Milestonesinformation-Planned date information

Project Fields-Project name, ID

CTMS

Actual information

Trial information-Trial ID-Name-Status

Patient Milestonesinformation-Actual date information (or planned)

Web services,Import-exportstandard tools

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Figure 5: The Synchronization screen shadows the target project’s comparable activities against your own.


Comprehensive Resource Management Planisware’s resource management toolset covers the entire process from resource forecasting at the role level to detailed individual resource time-tracking. The high level workflow is described next.

Estimation Tools

In the early stages of drug development planning, reliable estimates concerning resources and costs can be difficult to attain. Planisware’s predictive estimation engines enable users to generate resource and cost estimates quickly and with a standard level of reliability. Planisware offers two estimation engines commonly used for resource and cost forecasting:

• The Parametric Estimation tool provides the framework for computing forecasts based on project parameters and study drivers as well as industry or company-defined algorithms. This method is accompanied by function-specific driver screens with audit trail capabilities for focused driver management.

• The Estimation by Analogy engine calculates forecasts based on data pulled from a collection of similar historical or benchmarked projects.

Because rules are defined centrally, both methods provide a consistent, un-biased rough-cut estimate that can be compiled quickly and early on in the planning process.

For more accurate short-term resource and cost forecasting, expert judgment is the key. Easy-to-use spreadsheets and pop-ups support manual estimation for organizations or departments which do not utilize algorithms, while algorithm results can be leveraged as a starting point for those that do. Organizations that store algorithm-generated results often enable both audit trail and estimation locking features. Meanwhile, views comparing manual estimates vs. algorithm-generated estimates serve as a way to compare project estimates against a benchmark, and enable functions to improve resource estimates in the future.

Figure 7: Planisware’s Parametric Estimation capabilities enable quick and standardized resource and cost estimates during the early stages of planning. The Parametric Estimation engine can also be used to forecast timelines as well.

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Project Template

Rough descriptionof a project and itsactivities

InputParameters

Effort equationSchedule equation

Early estimates for:- Timeline- Staffing level- Cost

Scale Driver

Forecast Drivers- Resource demand drivers- Cost drivers- Adjustment factors

Examples of Drivers:- # of batches to process- # of screenings to complete- # of subjects- # of sites

Examples of equations:Computing # of medical monitors FTE for a Phase 2 Oncology study = 5*((NB_PATIENTS/2)*0.022)


PLANISWARE 5

Resource Capacity Planning

Resource bottlenecks are a large obstacle faced by pharmaceutical organizations. Assorted supply vs. demand vs. capacity views in Planisware identify over-allocations and under-utilized resources clearly. Anticipation of future resource shortages can provide Resource Managers enough time to investigate dif-ferent avenues for resolution. With early warning, re-arranging the timing or allocation of resources, hiring new employees or contracting temporary resources can be initiated in a timely manner.

Meanwhile, easy access to project data, like project priorities, provide Resource Managers background information when decisions regarding trade-offs in resource allocations or delaying vs. accelerating proj-ect tasks need to be made quickly. In addition, What-if capabilities allow Resource Managers to simulate resourcing changes for their departments across the portfolio of projects before making difficult decisions.

Resource Assignment

Planisware 5 contains built-in functionality and workflows designed to manage individual resource scheduling.

During the resource estimation phase, the resource workload, or FTEs, are forecasted at the role, job, or skill level. As effort-driven tasks approach, resource estimates can be transformed into resource requests for Resource Managers or Functional Managers to address.

Resource assignment screens enable users to quick-ly assign a single or multiple individual employees, contractors, or temporary resources to each task. Research capabilities help the manager find the best individual to assign to each task, given the timing and the skills required for the work, as well as the other priorities for the individuals.

Keyreportsprovideanunderstandingofresourcingutilizationlevels.Additionalreports,comparingresourceestimates,requested demand and supplied resources, provide further insight to resource usage for each department, each function, and the organization as a whole.

Time-Tracking

Planisware supports the integration of actual hours worked from third-party time card systems, or directly from Planisware’s TimeCard module. Integration of actual hours enables users to track time worked for all project stakeholders and can be incorporated into cost curve calculations like the estimate at completion (EAC) for your projects.

Comparisons between the actual hours worked and resource assignment supplied can be made along shared dimensions, like the resource or work breakdown structures. This type of assessment informs Resource Managers of errors in workload judgment and enables them to fine-tune future estimations. The TimeCard module, integrated with the rest of the system, ensures that data collection occurs in a timely manner.

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Figure 8: This bottleneck report shows the demand estimated for roles within the Product Safety department across the proj-ect portfolio, compared to the total capacity represented by the green line. Overallocations, highlighted in red, and drill-down capabilities provide insight into the source of issues.

Figure 9: The top of the screen displays tasks across projects that need to be assigned to a resource for the given department. The bottom displays the amount of work already allocated for each individual within that department. To assign a task, users drag a task and drop it by the individual of his or her choice.


What-If Analysis Planisware’s What-If Analysis capabilities enable users to create copies of projects to play with in a safe “sandbox” environment at the portfolio, project, and functional levels. In this environment, users can assess the impact of schedule changes like add-ing, removing, delaying or accelerating studies or work packages, changing future milestones, freezing projects, changing the scope of a project, or requiring a significant change in workload – all without affecting real project data.

Userscancomparevariationsagainstoneanotheror against the current live project(s), and then ac-cept the chosen changes permanently - if desired. Ultimately,theimpactassessmentaffordedbytheWhat-If capabilities enable well-informed decisions to be made. Risk ManagementPlanisware’s risk management toolset provides a full suite of risk assessment capabilities so project and portfolio managers can make educated decisions to further the success of their portfolios, programs, and projects.

Risk Register

This workflow follows a two stage process. First, a risk must be identified, assessed, and prioritized. Once a risk has been properly catalogued, an action plan can be created to mitigate, monitor the potential event, or control the probability or impact of the risk. Clients may incorporate the cost of risk avoidance, or risk management back into the project estimate.

Risk Adjustment and Portfolio Attrition

As projects progress, each decision point comes with the chance that the project will be put on-hold or cancelled. Planisware enables users to define a Probability of Technical Success (PTS) factor for each decision point, which can then be applied to the relevant resources and costs.

A portfolio view that takes attrition into account pro-vides organizations with a more realistic understand-ing of the probable demands on costs and resources “n” years down the road. This knowledge can be tracked and used to aid processes like managing the drug discovery pipeline, and monitoring resource capacity.

Monte Carlo Simulations

With this feature, users input the parameters of scenarios and then run simulations that calculate the probablistic distribu-tion of outcomes on monitored variables. This tool can be applied to answer questions like: What is the chance that my project will be completed on schedule? Within budget? What is the chance that these tasks will be on the critical path? Results of Monte-Carlo simulations enable users to take into account probability before a critical decision and to predict the value of mitigation plans.

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Figure 10: The timeline of a scenario, in pink, is compared against the active project in a Gantt chart. In the scenario, a delay to Phase II would eventually delay the launch date of the project by a quarter.

Figure 11: In evaluation of the project’s probability of success, the table displays Survival Rate (the likelihood of moving to the next stage) as well as the Risk Adjustment (probability to reach the given stage from the start). The graph shows that when the forecasted cost is risk-adjusted, the discrepancy is significant. The EAC is shown in orange, and the risk-adjusted EAC in blue.


PLANISWARE 5

Figure 12: Planisware was built with the flexibility to support interfaces with external systems in mind.

Collaboration Collaborative tools in Planisware 5 facilitate communication among the decision makers and stakeholders who should be re-sponsible, accountable, consulted, or informed in a variety of common business practices. This is achieved through system-enforced workflows that ensure that the right steps occur in the proper order, and that results, decisions, and information arecommunicatedvianotifications,messages,and/ore-mailstoallrelevantpartiesateverystep.

Pre-defined workflows push the timely communication of matters like issues, risks, resource requests, deliverables, docu-ments and stage-gate decisions at the project and activity level to the appropriate parties, while clear repositories allow all stakeholders review the logs at any time - so that your organization’s project team members, governance members, resource management, stay on the same page on key project concerns.

Integration Clients can make use of Planisware’s interfacing capabilities with Microsoft Office applications like Project, PowerPoint, Word and Excel directly from the user interface.

But it is often useful for organizations to implement a system-managed exchange of the planned data initiated and main-tained in Planisware with data from complementary systems used by the organization as well. For example, customers often benefit from interfaces with the following systems:

• Clinical Trial Management Systems (e.g. IMPACT, TrialWorks)• Enterprise Resource Planning Systems (e.g., PeopleSoft, SAP ERP - Planisware is certified SAP-Ready)• Content Management Systems (e.g., SharePoint)• Data Warehouses (for reporting via Cognos, Business Objects, Hyperion, etc.)

Planisware’s technical architecture was designed for the full flexibility to support integration with the external systems listed above, and more.

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Example CustomersPlanisware is well-established as the PPM solution of choice for pharmaceutical companies. Leading pharmaceutical companies of all sizes have relied on Planisware throughout the years. See below for examples of our life sciences customers.

Figure 13: Planisware has been building knowledge and gaining experience for years, while working with leading compa-nies in the life sciences industry.

Planisware is the leading global provider of world-class project and program portfolio manage-ment solutions. Planisware’s acclaimed configurability accommodates the company’s global cus-tomers across a variety of industries and empowers users to align the solution with key business programs and portfolio management processes. Planisware has been recognized as an industry leader by several esteemed analysts and has achieved Stage-Gate Ready© and SAP® integration certifications.

www.planisware.com888-752-6479

Planisware for Pharma_US-120910


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