Creating an IT Roadmap
for Clinical Operations
An illustrative approach
Todd Tullis
todd@hermosatech.com

Benefits of the Process
• Create alignment between business and IT
strategies, priorities and initiatives (and ensure
alignment for current projects)
• Identify opportunities for IT to better enable
business objectives (including application of
emerging technologies)
• Empower IT staff to think strategically, and learn
to translate strategic plans into tactical ones
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Steps of the Process
Assess Define Confirm
Current State Options Priorities
• Inventory current • Identify new gap-closing • Rationalize prioritized
systems/solutions and IT opportunities for IT (note projects and programs
project/programs per some gaps can be addressed against budget constraints
clinical operations function through business-only • Define and agree on 5-year
initiatives as well)
• Assess current roadmap
systems/solutions for • Define, estimate, and • Revisit annually
functional and technical summarize new gap-closing
adequacy projects and programs
• Listen to business pain • Prioritize new and existing
points & understand projects and programs
strategic business
objectives
• Agree on gaps between
current capabilities and
desired future state (per
clinical operations function)
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Factors for Success
• Commitment of business representatives to
participate in full
• Willingness of IT staff to “think big”
– Going beyond a 1 year planning horizon
– Estimating large projects with imperfect information
• Up-front understanding of the scope of clinical
operations in your organization
• Understanding the goals and priorities of R&D
Senior Management (and getting their explicit
support for the exercise)
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Defining Scope of Clinical Operations
Manage Portfolio & Projects
Plan, Track, and Manage Studies
Manage Supplies
Plan Projects and
Collect and Process Clinical Data
Design Studies
Manage Clinical Samples
Analyze and Report Clinical Data
Recruit Investigators and Patients
Manage External/Medical Product Communications
Monitor Safety and Report Adverse Events
Author, Publish, and Archive Regulatory Submissions
Track and Manage Compliance
Cross-Project Data Warehousing and Analytics
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Key Planning Factors & Considerations
• How many business & IT stakeholders will participate?
• How detailed do project estimates need to be to allow
for effective decision-making?
• How many functions are included in the scope of
Clinical Operations for your organization?
• 6-8 weeks is an appropriate timeframe to develop a
roadmap for Clinical Operations (for most
organizations)
– Business representatives must be available for key
workshops and offline/1-on-1 review & discussion – approx 6
hours per week
– IT staff must have capacity to create content for business
review and keep the process moving forward – approx 2 days
per week (assuming 1 staff per in-scope function)
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Deliverables
• Clinical Operations capability assessment
– Adequacy assessment for current application portfolio
– Prioritized capability gaps between current and future
desired state
• IT initiative high level plans
– Description and benefits
– Cost & duration estimates
– Assumptions, dependencies, & risks
• 5-year roadmap of planned initiatives
– Defines the timing and phasing of initiatives
– Planned cost and resource spend by quarter (for years
1-3; by year for years 4 & 5)
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Questions/Further Information
• Contact Todd
– todd@hermosatech.com
• Additional information on our website
– http://www.hermosatech.com
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