Ensuring Efficiency and Speed with Practical Solutions for Clinical Operations

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CompanyName
Xxxx - Microsoft
Jim Patterson - OnePlan
Ensuring Efficiency and Speed with
Practical Solutions for Clinical Operations
Innovate, Adapt & Deliver

Biotech/Pharma Customers
Who Is Robert Happy, Managing Director, Biotech-Pharma PMP, MCTS, MCT?
rhappy@oneplan.ai call, text, email anytime (707) 280-8560
• Over 25+ yrs in
project & portfolio
management
consulting and
training experience
in Biotech-Pharma
•Published book,
multiple articles
and training
programs on PM
and Project Tools
•Worked with 100’s
of organizations
and 1000’s of
individuals to
optimize PPM
•PMP certified and
senior level
consultant/advisor
•Managing Director of
OnePlan,
Biotech/Pharma
Practice
•Implemented
multiple GPMs/PMO’s,
processes, systems
from large to small
start-up Biotech-
Pharma while working
with all the main
functions from Early
Research/Discovery,
Nonclin, CMC,
Clinical, Regulatory,
Commercial

- Global PPM Leader for 5 Consecutive Years
Consistently Recognized as a Market Leader
OnePlan cited as a top vendor in
“Determine the Future of Microsoft
Project in Your Organization”
Strategy and Innovation
2023 Peer Insights
“Voice of the Customer”
Strategic Portfolio Management

Key Challenges Facing BioPharma Clinical Operations
Along with the ongoing challenges for managing clinical operations such as study design/approvals,
patient recruitment/retention, dealing with complex regulations, drug supply/supply chain and data
management – OnePlan (Strategy, Project, Program & Portfolio Management Platform) can optimize
performance and address the following challenges to name only a few key areas:
– Operational Efficiency – managing complex clinical programs with feasible timelines, budgets and resources for
various study designs with multiple sites. Help ensure efficiency and speed across your portfolio.
– Stakeholder Management – clear communication and coordination across all parties involved for both internal
(CMC, Reg, Nonclin) and external stakeholders (CROs, sponsors, regulatory bodies, and clinical sites). Ensure all
stakeholders are working on prioritized mission critical activities.
– Financial/Budget & Resource Management - Clinical trials are expensive and managing budgets & resources
effectively to avoid overruns is critical. Optimizing the allocation of resources and funds to maximize efficiency.
– Technology Integration – consolidating clinical program related information in one place for quick and easy access
to real time information to optimize alignment of strategic goals and execution. One point of entry, one source of
truth.
– Visual Meaningful Consistent and Reliable Information - served up in the way you need it to align on mission
critical activities and drive timely key decisions with meaningful visualizations & dashboards backed by the ‘right-
sized’ detail to give you peace of mind.

PROJECT & PORTFOLIO MANAGEMENT FOR CLINICAL DEVELOPMENT PROGRAMS, LEADERSHIP & TEAMS
Corporate & Quarterly Goals
Portfolios (Assets/Molecules - Development, Commercial, Marketed)
Franchise/Therapeutic/Disease Areas
Indication – Products/Programs
Discovery Phase 1 Phase 2 Phase 3 Submission Launch
Optimize Resource Utilization,
Communication Across Clinical Programs &
Teams
We specialize in ‘right sizing’ Tools to
Maximize your ROI
• By Dev Stage, Region, Therapeutic
Area, Asset/Indication and/or
Functional Team for effective
communication and optimize time to
submission & launch
• Associate and align – one point of
entry, one source of truth – drive
alignment on meeting goals
• Aggregate and rollup to facilitate
better decision-making
• Variety of tools right sized to meet
your exact needs
• Translate to common dashboards and
visualizations
Clinical
Operations

Demonstration Flow
• Part 1 - Clinical Ops/Dev Plans All in One Place Consistently &
Reliably
• Part 2 – View the Holistic Picture with Meaningful Views Tailored To
Your Exact Needs
• Part 3 – Prioritize & Select the Right Clin Programs while Balancing
Resources and/or Costs to Maximize Benefits
• Part 4 – Align Teams & Programs with Goals, Objectives & Key
Results (OKR’s)
• Part 5 – Execute & Deliver Results with Team Collaboration Focused
on What Matters Most

Part 1 - Clinical Ops/Dev Plans All in One Place Consistently &
Reliably
• Use consistent tools,
templates, metrics
and terminology
• Create one source of
truth and preferably
one point of entry
• Align stakeholders
up and down and
across the org with
no surprises
• Flexibility and
scalability with tools
with real time access
• Highly secure cloud
based with flexible
permissions

Use Consistent Template Library to Efficiently Build Clinical
Development Plans with Built In Metrics & Terminology
Use standard set of
templates for various
clinical ops plans, studies,
and scenarios
Drive consistent
terminology, process
and metrics.

Manage Clinical Plans at Any Level of Detail Across Indications
Manage clinical timelines directly in OnePlan, Smartsheet, Microsoft Project (Desktop Pro or For the Web) and option to
experience it via MS Teams.
Track all your GRAIDL (Goals, Risks, Actions, Issues,
Decisions, Lessons Learned) all in one place. Also
program metadata (details), financials and resource
plans – all highly configurable to meet your exact
needs.
Note: Views, Lists, Fields, Layouts – all highly configurable

Software
Development
Ideation
Professional
Services
Financial
Management
Work
Management
Service
Management
Private Cloud Connector
Use Integrators to Capture All Clin Ops Info In One Place
Dynamics
365
Dynamics
365
Dynamics
365
Strategy
Enterprise
Architecture
Viva Goals
• Data / field mapping
• Business rules
• Workflows
• Scheduling
• Logging
• Extensible and Flexible
Let’s Take A Look

Part 2 – View the Holistic Picture with Meaningful Views Tailored To Your
Exact Needs
• View portfolio of
clinical dev plans
by stage,
therapeutic area,
asset, region and
so on
• View the
information that
is important to
you in the way
you need
• Easily drill up or
down as needed
from the high-
level big picture
down to the
ground level
• Various views for
various
stakeholder
needs – easily
tailor to your
audience

Use Interactive Automated Dashboards to Align & Optimize
• View portfolio of
clinical dev plans
by stage,
therapeutic area,
asset, region and
so on
• View the
information that
is important to
you in the way
you need
• Easily drill up or
down as needed
from the high-
level big picture
down to the
ground level
• Various views for
various
stakeholder
needs – easily
tailor to your
audience
Let’s Take A Look

Part 3 – Prioritize & Select the Right Clin Programs while
Balancing Resources and/or Costs to Maximize Benefits
• Prioritize clin
plans based on
key business
drivers & goals
• Scenario
planning &
modeling
• Plan and model
based on
resource capacity
and future needs
• Plan and model
based on
financial goals
and targets
• Visualize results
& make
decisions

Use OnePlan’s AI Engine (Sofia) to Help
Drive Decisions and Get Information Fast

Use the Modeler to Balance Resources

Use the Modeler to Balance Finances

Use Resource Plan Heat Map to View & Balance Resources
Use the Match and Replace
Function to Manage Over or
Under Allocations

Use Master-Sub Plans to View Across Multiple Clin Programs
Load plans across programs to optimize scenarios & timelines at a more granular level
Let’s Take A Look

Part 4 – Align Teams & Programs with Goals, Objectives & Key
Results (OKR’s)
• Manage and
track
organizational
goals and/or
objective &
key results
(OKRs)
• Align goals &
objectives to
programs,
projects, tasks
• Ensure teams
are working on
mission critical
objectives
• Utilize
meaningful
visualizations
to optimize
performance

Associate Goals to Projects & View Interactive Dashboards
You can associate goals with
programs/projects and team
members and track status as
needed.
Let’s Take A Look

Part 5 – Execute & Deliver Results with Team Collaboration
Focused on What Matters Most
• From SLTs/ELTs to
team members,
ensure everyone is
working on mission
critical activities
• Collaborate across the
organization from
strategic decision
making to daily
workload/task
management
• Tailor meaningful and
usable views &
information for each
stakeholder
• Balance the the tools
and information
needs to just right
(not too much and
not too little) to
optimize performance

Team Members Aligned at the Ground Level
All work aligned with strategic goals & programs = mission critical tasks
Use our OnePlan app to
easily manage on your
mobile device/phone.

Manage RAIDL+ Items/Logs the Way You Need To
Out of the Box or
Configure You Way:
Changes, Goals, Risks,
Actions, Assumptions,
Issues, Decisions,
Lessons Learned,
Agenda Items. Add new
list logs or delete to
simplify – whatever you
need all in one place.

Experience OnePlan Integrated with Teams and/or SharePoint
Use OnePlan directly in
Teams or Integrate with
SharePoint for Document
Management
Let’s Take A Look

For more information:
contact@oneplan.ai
rhappy@oneplan.ai
Free Offers and Next Steps
• FREE – BioPharma OnePlan
Trial
• FREE – Roadmap Workshop
• FREE – Personalized 1:1 Demo
www.oneplan.ai
oneplan.ai/biotech-pharma-solution

Contact Us
contact@oneplan.ai
www.oneplan.ai
Robert Happy
rhappy@oneplan.ai
Thank You!!
The Power of One

Ensuring Efficiency and Speed with Practical Solutions for Clinical Operations

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