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Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Community Discussion:Transformation Management: Effective Strategy & Successful Adoption
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Background InformationPre-recorded presentation: Transformation Management: Effective Strategy & Successful Adoption
Erika Stevens, MA
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
What is Transformation Management?➢Transformation Management
‒ Transform- a change into something or something different, or the process by which the change happens
‒ Management- the control or operation of a business or organization
‒ Macmillan Dictionary
As combined, Transformation Management is the process of operationalization of a change with people (someone) and process (something)
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Change Management
Process
• Change management encompasses the various dimensions of the organizations operating model: operational strategy, process and policy, people and organization, technology and data and performance management.
• The process captures the change challenges, develops initiatives to manage these change challenges and put in place mechanisms to monitor effectiveness.
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Change Management Enablers Project Site
•Site containing all project resources and a means for providing a single source of information for all users about the project
Communications
•Archive of all communications shared for this effort (can be organized by role as appropriate)
Training Checklist
•First step for all end users to review
•Instructions detailing training requirements, corresponding actions to support implementation, and relevant information on getting access
Training (eLearning, TTT etc.)
•Learning Solutions leveraging various modalities based on business requirements, content, audience and resources
Job Aids/User Guides/Quick Reference Cards (QRCs)
•Additional easy-to-access learning solutions to support effective adoption
Implementation Effectiveness Survey
•Evaluation of training/communications and other aspects of deployment to gather feedback from users on their effectiveness, for modifying approach as appropriate and identifying any additional support needs
Change Agent Network
•Facilitates the coordination of rollout activities, represents interest, serves as SME for that area, champions the change, helps in cascading messages, providing feedback, identifying risk areas, and accountable for end-user readiness
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Transformation Management Process
➢Transformation management requires mechanisms for enabling successful change to organizations through alignment and solidifying the desired outcome (s)
➢Transformation management processes allow:
‒ Evolution in a controlled method
‒ Support continuous improvement and innovation
‒ Assessment of business impact
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Transformation Management Different types of transformation:
➢The transformation should contain a process for managing day-to-day continuous improvement efforts or business problems that arise;
➢ It should include philosophies for driving overall transformation initiatives, a continuous innovation management process;
➢ It should include a process for updating and managing any changes to the transformation;
➢ It should document a common understanding on how the initial transition of scope of work is managed.
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Business Impact Assessment
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Transformational Change Risk Mitigation
LACK OF SPONSOR SUPPORT
LACK OF STAKEHOLDER COMMITMENT
SETTING UNREALISTIC EXPECTATIONS
CONCERNING THE OUTCOME OF THE
PROJECT
STAKEHOLDERS NOT “LETTING GO” OF THE OLD WAY OF DOING BUSINESS
MANAGING RISKS TO INCLUDE ISSUES
ESCALATION AND RESOLUTION
Identifying risks, the impact of those risks and the probability of risk mitigation-
Change management risks include:
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Risk Assessment
➢ Understanding business and people risks enables documentation of potential risk and associated mitigations
➢ Enables real-time monitoring of the project and faster course correction
➢ Completion of risk/employee surveys
➢ Identification of project and people risks
➢ Continued communication and identification of project risks
➢ Identified risks and mitigations
➢ Risk Mitigation plan
Why are we assessing
risks?
What do we need from the
Business?
Expected
Outcome (s)
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Transformation Management
Initial Transition
• Transition Management plan
Ongoing Transition
• Transition Management
• Continuous Management
• Invention
• Structured Innovation Management Process
• Contractual Change Management
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Business Readiness
Launch of
Readiness
Activities
“Valley of
Despair”
Perf
orm
ance a
nd O
utp
ut
Performance Dip
Sustained
Performance
Improvement
T-N Go Live Post-go live
What is business readiness?
Identifies barriers for future transformation Provides evidence for business solution
Enables pressure testing
What do we need from the business?
Resources
Transparency/ collaboration
Agreement
Outcome (s)
Level set to change
Solidify approach
Establish alignment
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Readiness Assessment Check
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Readiness Assessment
Measures the business readiness capability for the transformation
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Ongoing Transformation Management
After the initial transition work, those involved in the change will focus on ongoing transformation management.
Better Process Different Process Innovation
Both are drivers of Innovation!
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Continuous Improvement Vs. Innovation
After the initial transition work, those involved in the change will focus on ongoing transformation management.
Better Process Different Process Innovation
Both are drivers of Innovation!
• Similar Scope• Lower Impact • Less Investment • Low Risk• Limited Sign-off
• Larger Scope• Greater ROI • Larger Investment • Increased Risk• Multiple Stakeholders
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Innovation Management vs. Continuous Improvement
Innovation Management Continuous Improvement
• Tends to focus on larger-scale transformation initiatives that often need investments or resources
• Tend to be cross organizational in nature and are tied to the desired outcome (s)
• Tend to focus on managing improvements to day-to-day operations
• Tend to have short project timelines, are limited in scope and tend to require limited resources to implement
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Transformation Management Performance
0%
100%
Operational Impact
Complete Tasks Total Tasks
14%
86%
Communication and Branding
Complete Tasks Total Tasks
0%
100%
Project Opportunities and Goals
Complete Tasks Total Tasks
0%
100%
Training Impact
Complete Tasks Total Tasks
0%
100%
Development and Deployment Support
Complete Tasks Total Tasks
0%
100%
Go Live/Post Go-Live Support
Complete Tasks Total Tasks
Illustrative
Clinical Trial Risk and Performance Management vSummit 8-10 September 2020
Thank you