Clinical Architecture is an ecosystem of business systems, processes and information that supports drug development operations.
Benefits for the Business
Business decisions that take into account the clinical architecture impact from changes, enable transformation to a more agile, integrated enterprise.
The strategic elimination of unnecessary or redundant systems significantly reduces operating expenses and complexities.
Ability to strategically integrate data with external systems (CRO, IRB, Sites, Co-Sponsors, Vendors)
End-users welcome new tools, buy into the value, and change behaviors to maximize efficiencies.
Strategic content flow to support regulatory authority communications and submissions
Content is actionable, reusable, and mineable for additional business benefit
Challenges for defining clinical architecture
Life science companies are being confronted with challenges resulting from complexity in:
Stakeholders/users of the eClinical Systems have greatly increased over the years
Additional groups within life sciences companies
Clinical Operations systems landscape is evolving and maturing at a rapid rate:
Larger variety of system capabilities (lines between systems have blurred)
More vendors offering competing products (harder to identify industry leader)
Systems that must integrate to produce value
Which leads to ever-increasing complexity!
Shortcomings of the old way of defining clinical architecture
Performing the analysis at the department/function level results in duplicative systems and does not take into account the needed integrations.
Focusing on features instead of capabilities fails to clarify optimal solutions as many system categories are ecompassing an ever-increasing feature-set.
Impact of the old approach to defining clinical architecture
This complexity has created challenges for both the business and IT:
Processes and systems where each step of the product development lifecycle has an enabling technology
Business processes and systems that are challenged to support and scale to the anticipated growth.
Lack of understanding of interfaces between application portfolios and functional areas.
Systems are not strategically integrated and ultimately knowledge is not consolidated or easy to access.
Struggle to produce an integrated R&D architecture.
There must be a better way
There is a light at the end of the tunnel however. In my next post I will examine the new approach to clinical architecture, which can actually help any team define their future state in a manner that drives a business forward.
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Chris McSpiritt is the Clinical Practice Lead for Paragon’s Life Science Research& Development team. Chris has over 10 years of pharmaceutical industry experience in R&D and has applied his business architecture, business process management, and analytical skills to help pharmaceutical companies improve the conduct of clinical trials for global life sciences companies. Chris holds a BA in Psychology from the University of Notre Dame. He is an active member of the Business Architecture Guild, Association of Business Process Management Professionals, Project Management Institute, and Drug Information Association.