Biotech Research Platform Architecture
An anonymized Larkinized engagement illustrating EA value in healthcare.
Client Context
A biotech firm building cloud research platform for trials and lab informatics. Larkinized engaged with CIO and business sponsors across healthcare.
Challenge
21 CFR Part 11 scope debates; hybrid HPC and SaaS sprawl.
Approach
Validated platform zones; reference architecture for LIMS integration.
Architecture Decisions
GxP boundary diagrams; electronic signature standard; data lake segregation.
Outcomes
Trial startup accelerated; audit observations reduced.
Lessons Learned
Label validated vs research zones before architects design integrations.
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