The Clinical Atlas
A Modeling and Execution Environment for Clinical
Process Solutions
Dr. Kal Bugrara
Northeastern Univ
Kal Bugrara
Northeastern University
Outline
The Clinical Trials Process
What is the Atlas?
Social-Technical Systems
Constructing Business Architectures for
clinical trials
Demo
Kal Bugrara
Northeastern University
Objectives
Develop software tools, which we have
been fine-tuning for about ten years, to
bring effectiveness, safety, and efficiency
to health care enterprises through the use
of state-of-the-art practices in IT.
Kal Bugrara
Northeastern University
Personal Profile
Director of the MSIS (Master’s of Science
in Information Systems) Program at
Northeastern University, Boston, MA. I
hold a Ph.D. in Computer Science from
Indiana University and is the founder and
President of Designing Systems, Inc.
Kal Bugrara
Northeastern University
To understand…
*Drug development is a blanket term used to
define the entire process of bringing a new drug
or device to the Market. It includes Drug
discovery, product development, pre-clinical
research(microorganisms/animals) and Clinical
trials
_________________________________
*The definition is from www.wikipedia.com
Kal Bugrara
Northeastern University
Preclinical
Testing
Step 1
Laborator
y/Preclinic
al Testing
Trial Size
Purpose
Assess
Safety
and
Biological
activity in
the
Laborator
y and in
animal
model
Clinical Trial
Step 2
File IND
Applicatio
n with
FDA
Obtain
FDA
approval
to begin
clinical
testing in
Human
after
Promising
result in
Laborator
y
Step 3
Phase 1
15 -30
People
Determine
What
dosage is
safe , how
treatment
should be
given
Step 4
Phase 2
Step 5
Phase 3
20-100
People
100 –
1000
People
Evaluate
effectiven
ess
Look for
side effect
Determine
whether
the new
treatment
is a better
alternative
to Current
Standard
All Drugs
4.4 Years
8.6 Years
All
Anticancer
Drugs
3.8 Years
10.4 Years
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Post Clinical
Trial
Step 6
File BLA
/NDA with
FDA
Inform
the FDA
of Phase 3
data
which
support
drug
safety and
better
performan
ce over
current
standard
treatment
Drug
Appro
val
Step 7
FDA
Approval
Several
Hundred to
Several
Thousands
People
Review
Process /
Approval
(Sometimes
also called
Phase 4
Trial )
1.4 Years
1.5 Years
Northeastern
14.4
Years
15.7
UniversityYears
Duke caBIG Cancer Bioinformatics CTMS Business
Process Architecture Model
Layer 1
Layer 2
Layer 3
Layer 4
Bench
Plan
Research
Study
Manage
Initiate
Study
Integrated
Study
Clinical & Translational
Conduct
Manage
Subjects
Study
Report
Manage
Clinical
& Analyze Study
Data
Perform
Research
Enterprise
Common
Resources
Study Quality Control
Identifies the next level of detail
Kal Bugrara
Northeastern University
Clinical Trial Processes
Extremely complex and all-encompassing
The cycle is marred with trial and error,
unsafe practices and ineffectiveness
Potential for fraud and bias.
Clinical trial subjects can suffer illnesses
and occasionally even loss of life.
Only 10% of clinical trials now lead to
successful drugs.
Kal Bugrara
Northeastern University
Current clinical IT practices
Clinical knowledge is difficult to find and
reuse to further clinical studies due to
poor and often antiquated IT practices.
Clinical and IT practices now in use are
weighed down by fragmented processes,
disconnected systems and users, and poor
management of data.
Errors and data-quality problems are
pervasive.
Kal Bugrara
Northeastern University
Current clinical IT practices
Focus narrowly on documentation for
compliance submission and regulatory
approval.
Fail to give enough attention to the actual
trial process. They ignore the people,
work activities, and the tools necessary for
a rapid, safe, and effective introduction of
new drugs to the market.
Kal Bugrara
Northeastern University
What regulators are demanding?
Board and management involvement of clinical management
activities
Issuance of management directives related to operations
Policies and procedures effectiveness vis-à-vis:
Delegation of duties across business, administrative and
operational lines
Expertise and skill-sets of its compliance organization
Clinical data
Clearly defined work responsibilities among management, staff,
contract research organizations, and outsourced service providers
Corrective actions in response to requests for remedial actions
A panoramic view of the organization in terms of who did what,
when, etc.
Kal Bugrara
Northeastern University
A simplified view of the drug development value chain
Key Roles:
1. Researcher/PI
2. BioBio-statistician
3. Coordinator/Nurse
4. Study Design Team
5. Patients/Participants
6. IRB
7. Sponsor
8. Financial Analyst
Manage Drug
Configurations
Drug
Process
Manage
Compounds
Manage
Study
drug1.jpg
Schedule
Visits
Manage
Subjects
Clinical
Procedures
Welcome
Subjects
Kal Bugrara
Northeastern University
Key Questions
How to manage the clinical process holistically, breaking down
individual management silos to achieve organization and
effectiveness (eliminating unnecessary work, e.g., manual
monitoring of adverse events)?
How clinical teams (manufacturing, safety, recruitment, research,
investigation, managing participant visits, finance, compliance,
etc.) can best collaborate
How to manage accountability through different business units
and across functional boundaries?
Decentralized
Operations
How to resolve disputes and deliver accountability?
Kal Bugrara
Northeastern University
To address the complexity of
clinical trials
A socio-technical system
Requires a top down design where the
system gives way to the business
architecture
Model-Driven with minimum programming
Start small and grow
Kal Bugrara
Northeastern University
The Socio-Technical
Dimension
Organizational development that puts into
effect complex organizational work design
by acknowledging as essential the
interaction between people and
technology in workplaces. This concept
pertains to the relation of complex social
infrastructures and human behavior and
works toward linking productivity with
well-being.
Kal Bugrara
Northeastern University
The project
Our aim, more specifically, is to provide tools to apply
the theory of Socio-Technical Systems to clinical trials.
That is, we emphasize organizational structure, people,
teams, and the work itself as what needs to be properly
designed for the sake of effective, safe performance as
well as to make sure that people are well supported.
Kal Bugrara
Northeastern University
What we have achieved so far…
Object model for clinical data
Compound configuration tool
Drug management
Study configuration
Recruitment tool set
Work in progress
Clinical trials architecture
Kal Bugrara
Northeastern University
Integrated clinical trials object
model
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Northeastern University
Doctor/Nurse Team
Receptionist responsibilities:
After a receptionist assigns a
scheduled appointment to a
Doctor or a nurse:
Select an appointment and
review the required procedure
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Perform the procedure
Capture all the required data in
this Northeastern
case a physicalUniversity
exam
Perform Clinical Procedure
Kal Bugrara
Waiting
participants
to be
examined by
View the
aofprocedure
details
a University
Northeastern
specific
selected
Kal Bugrara
View their
medical
history
Northeastern University
Capture Procedure Data
Kal Bugrara
Capture the
procedure
Northeastern
specific
dataUniversity
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
The Atlas
Serves as an exact mirror of an enterprise
Capable of defining and in turn managing
the behavior of an institution in its entirety
Enforces “Business First” discipline in
building critical software
Kal Bugrara
Northeastern University
The benefits
A real business communication
infrastructure to promote multi-level
cooperation, clarity, and organizational
responsibility
Users can easily construct meaningful
digital representations of their work
environments
Kal Bugrara
Northeastern University
The resulting representation in
Software
Serves as a map, an organizational
memory, capturing what is functioning all
the way to backroom operations, showing
who is doing what, at all levels of
management and record keeping.
Kal Bugrara
Northeastern University
Scale is important
We start small, one component at a time.
The Atlas will integrate all operations:
from strategic goal setting to project
management, the entire IT network, and
all communication channels—in other
words, all aspects of an institution’s
infrastructure.
Kal Bugrara
Northeastern University
Three main disciplines
A precise common vocabulary (ontology)
for organizational socio-technical work
environments,
The design or component assembly editor
(configuration console), as well as
Mapping and run-time execution engines.
Kal Bugrara
Northeastern University
A common language for the
assembly of virtual enterprises
The elements of the language must be intuitive
and allow for the construction of business
structures in terms of
Strategy -> process -> operations
The language also has to be formal and
rigorous enough to provide for program
execution
Strategy->process->operations is the
Executing SYSTEM
Kal Bugrara
Northeastern University
A Business Architecture (top down)
1
Opportunity/
Risk
Strategy Processes Operations
2
Mission
3
Management
Vision
4
Goals and
Measures
5
Service
Offering
6
Market
Offer
7
Business
Processes
8
Business
Operations
Kal Bugrara
Northeastern University
Overview of the Strategy, Process, and
Operational Linkages
CAPABILITIES
STRATEGIC OPPORTUNITIES
MARKET
MISSION
Think
VISION
BUSINESS
BUSINESS STRATEGY
LEADERSHIP
Goals & Measures
FUNCTION
Procedure
Plan
Resources
TARGET
MARKET
OFFERING
ACTION
ACTION
STEP
OFFER
OFFER
OFFER
Offering
EVENT
LEADERSHIP
PROJECT
Decision
ORDER
OPERATION
Business Center
Instructions
Work Product Tools Routing
TASK
TASK
TASKResource
FUNCTION Procedure Kal Bugrara
CUSTOMER
EVENT
Act
People
Northeastern University
The design process produces a business map
covering all aspects of the business
Business
Processes
Business Operations
IT Systems
Business operations such as people doing the
work and their skill sets, jobs they hold, business
units they report to, and their work responsibilities.
Tools they need to facilitate the work. teams they
belong to, and services they offer to others are
also specified.
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Customers
Management Structure
Products
Management Structure
such as responsible
leadership, jobs, leadership
goals and measures,
mission, vision, action plans,
as well as the hierarchy of
management accountability.
Business Process
such as work activities,
policies and
procedures, inputs and
output, and business
rules. Business rule
driven procedural
variations and
exceptions are
captured. Since
processes manifest
themselves as
business tasks, visual
presentation of the
work steps are
specified as well.
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Governance such as the organizational structures, responsible leadership,
jobs, leadership goals and measures, mission, vision, action plans, as well
as the hierarchy of management accountability. Elements of risk such as
events and impact, threats, risk weighting, and alert identification are
specified. Policy statements linked to strategy are stated.
The Atlas provides a
panoramic view of
organizational space
Strategy Design
Business Center
operations such as
people doing the work
and their skill sets, jobs
they hold, business
units they report to, and
their work
responsibilities. Tools
they need to facilitate
the work. teams they
belong to, and services
they offer to others are
also specified.
Governance Structure
Work Design
Process Definition
Operations
Process
Business Process
such as policies and
procedures, business
terms, work activities,
and business rules.
Business rule driven
procedural variations
and exceptions are
also captured. Visual
presentation of the
work steps are
specified as well.
Socio-tech clinical work Environment
Communication such as governance
work models can be configured
easily. Work requests, issues
management, collaborative dialog
processes, case management,
escalation and problem resolution.
Message Definition
Information Definition
Communication
Data
Data
REPOSITORY
Screens, Data Schemas,
Business Processes, Java & Service Components
Participant, visit, procedures, etc.
Supports
Implementation
Execution
IT environment such as software components,
application, systems, databases; and the
enabling execution platforms, and computers.
Kal Bugrara
Northeastern University
An Example:
Constructing a business
architecture
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A system is a configuration of operational centers
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Designing
BusinessNortheastern
Inc. University
Business Centers
A business center is where working people
go to fulfill their job responsibilities. A
business center
Includes work responsibilities, or
processes
Includes tools to facilitate the work
Provides services to others
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Northeastern University
Process Steps move through operations
centers
TOOLS
SERVICES
MACHINES
BUSINESS
CENTER
PEOPLE
STEP
BASE
BASE
BASE
FUNCTION
BASE
FUNCTION
FUNCTION
WORK
FUNCTION
RESPONSIBILITY
RESOURCE
Work
Responsibility
Results
Measures
Samples
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Observations
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A Process-Oriented Paradigm vs Just-in-Time Tools
Tool
... Work responsibility
(Task)
The performer of the work is intent on achieving a
certain objective. The objective could change/evolve
depending on the current state of the conversation.
Tool
Tool in
in action
action
Tools are optional aids and are
there to help the performer
complete the task at hand and
nothing else.
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Northeastern University
Working people connect to their designated work
areas in order to fulfill their work responsibilities
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Designing
BusinessNortheastern
Inc. University
People
operate from within their work areas
fulfilling work responsibilities using available
tools
Kal Bugrara
Designing
BusinessNortheastern
Inc. University
The CS Management center is where team leaders go to
fulfill their managerial responsibilities
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Designing
BusinessNortheastern
Inc. University
The
System adminstrators have the
responsibility of managing the system
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Designing
BusinessNortheastern
Inc. University
Linking work and
management
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Designing
BusinessNortheastern
Inc. University
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Designing
BusinessNortheastern
Inc. University
Sammy is fulfilling his work and managerial
responsibilities toward his team. The team’s work
responsibilities are as mandated by Sammy
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Designing
BusinessNortheastern
Inc. University
Process Example
Function/Activity
Procedure/Method
Step
Service
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Northeastern University
Work
does not flow – responsibility does
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Designing Business Inc.
Kal Bugrara
Designing
BusinessNortheastern
Inc. University
Kal Bugrara
Designing
BusinessNortheastern
Inc. University
Usability
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Performer Work Area
Participant Profile
Own Work
Incoming Work
Work Area
Outgoing Work
Shared Team Work
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Northeastern University
A Typical User Interface
Participant Profile
Time
Navigation
Service
Offers
Just-in-time-tools
Business Task
Tasks
Completed
Abort
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Next
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A Task-Oriented Paradigm
vs
Just-in-Time Tools
Tool
...
Business Task
The performer of the work is intent on achieving a
certain objective. The objective could change/evolve
depending on the current state of the conversation.
Tool
Tool in
in action
action
Tools are optional aids and are
there to help the performer
complete the task at hand and
nothing else.
Kal Bugrara
Northeastern University
Monitoring and
Auditing services
Atlas Diagnose
Atlas Operate
The
Business
Atlas
Platform
Automated
management & control
processes manifest
themselves through
user tasks and
screens. The
processes enforce the
policies and
procedures of the
business by driving the
work performed by
people
Atlas Design
Enterprise Architecture
of the ERM environment
capturing the structural
and behavioral aspects
of the entity in all its
dimensions.
Kal Bugrara
Northeastern University
Top-down design as a way to define
clinical enterprises that are holistic and
collaborative
Finance
Risk
Managemen
t
Sponsor
Study
Participant
Compliance
Kal Bugrara
Bio-statistician
Northeastern University
The Integrated Business Design Infrastructure
Channel Management
Business Task Services
Process Asset
Management
Tools
Business Configuration
Services
Management Structure
(people)
Operations Management
Operations
Web Services
Existing Application APIs
Services
EJBs/JDOs
Reporting Services
(Metrics)
Data Management Services
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
BUSINESS ENTERPRISE
Data
Elements
Job
Funtion
Views
Organization
Structure
Business
Rules
Process
Job
System
API’s
Services
Tools
Work Responsibility
User
Directory
Persona
Configuration
Business
Centers
Personal
Profile
Location
Channels
User
Account
Kal Bugrara
Northeastern University
Features Summary
An innovative approach to building realistic business management systems instead of
applications and workflows. Our approach is based on sound governance and
management accountability principles
An effective way of configuring and executing enterprise architectures that spans all
aspects of what goes on in the real-world enterprise
An unique way of integrating complex policies and procedures into the business
process.
Design changes are quickly integrated into the enterprise systems we develop,
reducing the cost of implementing changes to existing systems
Real-time measurement and reporting of resource usage: discovering where risk is –
done on an ongoing basis for each responsible business center, by product, by
customers, and by the work activities that deliver products to customers.
A robust multi-level security model
A collaborative work Model that is natural to how people work and get things done
Low cost of ownership due to an architecture that is based on sound design
principles.
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Configuration Studio
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Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Kal Bugrara
Northeastern University
Steps of Risk Analysis and Mitigation
Responsible Management
Leadership Team
1
10
Risk
On-Going
Issues
7
Implementation
Project
6
Risk
Mitigation
Action Plan
Agenda
Risk Objectives
8
Control Process
9
5
Control
Operations
Risk
10
Actual
3
4
Event Type
Event Type
Event Type
Event
Event
Exploiting
4
Indicator
Causes
Negative
Vulnerability
Impact
Asset
Goal
Kal Bugrara
At Risk
3
2
Northeastern University
Measure
Risk-Driven Management and Control
1. Atlas sensors detect relevant internal and
external events
Sense
2. Control components use
these events to continuously
monitor risk levels
Assess
Respond
Business
Processes
Goals and
Measures
Event
Business
Operations
Kal Bugrara
3. If risk is beyond a predetermined
level Control operations are
execution
Follow procedure
Signals
Control
Process
Risk
Fulfill Work
Responsibility
Control
Control
Control
Operations
Operations
Operations
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Business ...
… Strategy
… Process Design
… Operations Engineering
… Systems Requirements Specification
Kal Bugrara
Northeastern University