The most difficult part of any initiative is the behavior change it calls for, and RBQM is no exception. The implementation of RBQM without a implementation plan is just a wish.
To achieve their organizational goals, successful research organizations have figured out how to navigate change management. No matter the type of project or initiative, these companies treat any kind of plan execution with a change management mindset.
Part 2: How to fight your biggest enemy, time, by agile change management
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The Company
Since: 2013
Founders: RB(Q)M pioneers, ERT’s former Quality Data Systems Development Lead and team
and co-founded by Bayer’s former Head of Global Data Management
Focus: Full-service RBQM solutions, exclusively designed for clinical purpose
Headquarters: Olof-Palme-Str. 15, D-60439 Frankfurt am Main, GERMANY
220 Juana Avenue, San Leandro, CA 94577, UNITED STATES
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Our Three Brains
Understanding responses and behavior
▪ Reptilian (brain stem and cerebellum “gut brain”): Fight
or flight, eat it or be eaten. New system coming,
leadership is terrible! I’m going to quit!
▪ Mammalian (limbic “heart brain”): Values and social
analysis, how will it affect me? I can’t quit but let’s see
how great things are when their initiative fails.
▪ Human (neocortex “head brain”): Analysis, assessment,
planning. I need to hold tight until I have more
information, I’ll talk to my manager to see what they know.
12. Method How to Use When to Use Advantages Drawbacks
EDUCATION Communicate the desired
changes and reasons for
them.
Where there is a lack of/or
inaccurate information and
analysis.
Once persuaded, people
will often help with the
implementation of the
change.
Can be very time
consuming if lots of
people are involved.
PARTICIPATION Involve potential resisters
in designing and
implementing the change.
Where the initiators do not
have all the information,
they need to design the
change, and where others
have considerable power to
resist.
People who participate
will be committed to
implementing change, and
any relevant information
they have will be
integrated into the change
plan.
Can be very time
consuming if
participators design an
inappropriate change.
FACILITATION Provide skills training,
tools, resources and
emotional support.
Where people are resisting
because of adjustment
problems.
No other approach works
as well with adjustment
problems.
Can be time consuming,
expensive, and still fail.
NEGOTIATION Offer incentives for making
the change.
Where someone or some
group will clearly lose out in
a change, and where that
group has considerable
power to resist.
Sometimes it is a relatively
easy way to avoid major
resistance.
Can be too expensive in
many cases if it alerts
others to negotiate for
compliance.
COERCION Threaten loss of jobs or
promotion opportunities;
fire or transfer those who
can’t or won’t change.
Where speed is essential,
and the change initiators
possess considerable power.
It is speedy and can
overcome any kind of
resistance.
Can be risky if it leaves
people mad at the
initiators.
Dealing with Resistance – John P. Kotter and Leonard A. Schlesinger
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Change vs Transition
Beckhard’s Transition Model
Organizations ask/tell individuals to change but often neglect to properly manage/lead the transition.
SITUATIONAL
External forces create
the need for change.
PSYCHOLOGICAL
An individual’s reaction
to change.
Transition
happens Inside
Change comes
from Outside
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What is Change Management?
Management of the transition from the current state to the future state
CURRENT STATE
TRANSITION
STATE
FUTURE STATE
CHANGE MANAGEMENT – People side of the RBQM implementation
PROJECT MANAGEMENT – Technology side of the RBQM implementation
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Goals of Change Management
Meet the 3 H’s
▪ Ensure everyone
gets it intellectually
HEAD HEART HAND
▪ Ensure everyone
believes in it
▪ Ensure mechanisms are
in place for it to stick
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Developing a Change Strategy
It’s more than a simple procedural change
Prepare People
o Communication principles when building a sense of
urgency/vision for change
o Develop a change management team
o Identify and analyze stakeholder involvement and
engagement
o Pulling it all together with a Communication Plan
Plan the Change
• Picture of current – future state of the
change
• Asses the organization forces that will
help/hinder the change
• Analyze the organizational impact of the
change
• Analyze the drivers’ need to achieve
improved results
17. Are you going to
communicate ‘change’ or
‘opportunity’?
Or opportunity through
change…
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20. Change starts with you, the change manager:
▪ The Leader - drives change and transformation
▪ The Manager - ensures that processes run smoothly
▪ The Troubleshooter - resolves crisis situations
▪ The Ambassador - liaises with senior stakeholders
▪ The Coach - works with staff to maximise their capabilities
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#1
Change requires
individual energy, risk
and emotional
investment.
#2
Change counterintuitive;
go slow to go fast.
#3
Communication is critical
in every stage of building
commitment to change.
23. ‘Agile’ is a new way to
tackle change initiatives
by breaking them down
into iterative segments
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24. If You Want to
Change the
World, Start Off
by Making Your
Bed.
William McRaven
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Our fixation is on the finish line and what we
see as “success” tends to hinder our ability to
break down a process into manageable,
flexible pieces that focus on the next best
thing to do, and the next best thing after that.
26. SPRINT PLANNING
▪ Deadline, max 1–4 wks
▪ Sprint goal
▪ Ranked list of
requirements (backlog)
▪ Team selects starting at
top as much as it can
commit to deliver
▪ Task breakout
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What Goes Inside One Sprint?
Focus on the next best thing to do
SPRINT REVIEW
▪ Demo deliverables to all
▪ Discuss what’s done and
what wasn’t done (add to
backlog)
▪ Challenges you faced
▪ Adaptations you made
▪ What you’d do differently
DAILY ‘SCRUM’ MEETING
▪ Short stand-up (15–
30min)
▪ Done since last meeting
▪ Plan for today
▪ Obstacles
27. Key Takeaway #1
At its core, agile is based on the assumption that
circumstances change as a project develops.
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They Share the Same Goal
Maximum adoption and minimum post-implementation disconnects
Agile Change Management (daily execution)
o Focus on people interaction, early wins and pilot
implementations
o Step-by-step process
o Follows a lean, iterative blueprint
o Adapts to changing business conditions
o Facilitates the execution of deliverables
o Deliverables will be just-in-time and fit-for-purpose
o Bypasses/avoids webs of approval-based red tape
Change Management (the bigger plan)
• Change evaluation and definition
• Change strategy and plan
• Execute change program
• Measure benefits and results
• Transition to business-as-usual
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Don’t Confuse Goals
Change Management Goals versus Business Goals
RBQM Implementation Project Management
Deliverables are directly connected to business performance
goals, e.g.:
o Monitoring cost optimization (less SDV)
o Optimization patient enrollment (predictive analytics)
o Avoiding fines (CSM to detect misconduct)
o Optimization portfolio (vendor oversight)
Change (People) Management
Method to facilitate and drive e.g. RBQM
Project Management goals:
• Thru maximum adoption
• Thru minimum post-implementation
disconnects
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Don’t Forget Change Management
It aids on the people side of change
RBQM Implementation Project Management
Deliverables are directly connected to business performance
goals, e.g.:
o Monitoring cost optimization (less SDV)
o Optimization patient enrollment (predictive analytics)
o Avoiding fines (CSM to detect misconduct)
o Optimization portfolio (vendor oversight)
Change (People) Management
Method to facilitate and drive e.g. RBQM
Project Management goals:
▪ Thru maximum adoption
▪ Thru minimum post-implementation
disconnects
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Change Management in an Agile Environment
Get everyone on the same team and on the same agenda
32. Key Takeaway #2
Your agile change management system should align
with your long-term business goals.
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Cherry Pick Your First RBQM “Pilot”
Champions & Successes
Assemble a team of “champions” and early adopters
Studies with the highest probability of success
✓ Moderately complex study
✓ Across continents
✓ Phase 2 or 3
✓ Approximately 300 – 800 subjects
✓ Randomized trial or stratification study
Why?
Success is contagious!
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Cherry Pick Your First RBQM “Pilot”
Champions & Successes
Trust your people Reward output
not input
Start at the topUnderstand the
business case
Treat people as
individuals
35. Key Takeaway #3
Agile change management requires your organization to
have a flexible, people-centric culture.
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#1
At its core, agile is based
on the assumption that
circumstances change as
a project develops.
#2
Your agile change
management system
should align with your
long-term business goals.
#3
Agile change
management requires
your organization to have
a flexible, people-centric
culture.