Portfolio Accelerator · Life Sciences · Amazon Web Services
Clinical Trial Analytics on AWS: A Working Accelerator, Not a Slide Deck
A real, deployed clinical trial analytics platform on AWS: five Bedrock agents, a passing test suite, and a documented cost breakdown.
problem
The Problem: Trial Data Is Scattered Across EDC, CTMS, Lab, and Site Systems
Enrollment forecasting, protocol deviation triage, adverse event narrative drafting, and submission readiness checks are usually manual work spread across separate EDC, CTMS, and lab systems, each producing its own report on its own schedule. A sponsor or CRO evaluating aws clinical trial ai analytics consulting wants to see an actual system that connects these problems, not a proposal to build one.
demo
What We Built: A Real, Deployed AWS Clinical Trial Analytics Platform
This page showcases Kriv AI's clinical trial analytics accelerator on AWS, a genuinely deployed system, not a mockup. It runs on public CDISC reference data and locally generated synthetic case report forms. No PHI is used anywhere in the build.
Five Bedrock Agents, Five Real Problems
Five Amazon Bedrock agents, running on Claude Sonnet, each solve one concrete problem for one persona: Enrollment Forecasting for a biostatistician (returns P50/P80/P95 months-to-complete and an ON_TRACK/AT_RISK/BEHIND/COMPLETE status per trial, run nightly across the portfolio), Protocol Deviation Detection for a clinical data manager (classifies case-report-form deviations against ICH E6(R3) and drafts corrective-action recommendations), AE Narrative Generation for a drug safety physician (produces a structured CIOMS-I adverse-event narrative from the underlying trial data), Submission Readiness for regulatory affairs (surfaces live CDISC-conformance violations and days-to-PDUFA), and a 21 CFR Part 11 Audit Trail agent that SHA-256 hash-chains every agent invocation, data write, and electronic signature into a write-once-read-many S3 archive.
What the Demo Proves: Test Suite, Cost, and Real Data
The 21 CFR Part 11 audit-trail test suite passes 6 of 6, verifiable by any inspector re-running the hash chain in about 20 seconds. Six deployed Lambda functions and an AWS Glue Catalog with a crawler-registered table set sit behind the agents, backed by Redshift Serverless with 28 tables across bronze, silver, gold, ML-feature, and audit layers. The whole environment costs roughly $5 to $6 per month idle (Redshift auto-paused), $10 to $15 per day during an active demo period, and about $55 to $90 for a full four-day deploy-demo-teardown cycle, dropping to $1 to $2 per month for the audit-trail tail after teardown. The demo runs on the public CDISC SDTM Pilot dataset (306 subjects across 9 SDTM domains, roughly 100,000 rows) plus 5,000 locally generated synthetic case-report-form records across 3 mock trials with a 12% deviation rate. No PHI, anywhere in the build.
differentiation
Why This Is a Live Proof of Concept, Not a Pitch Deck
A Big 4 or large systems-integrator engagement for clinical trial analytics on AWS typically opens with a discovery workshop and a staffing plan. Kriv AI can walk a sponsor through this exact system, live, on the first call: five working agents, a passing compliance test suite, and a real cost breakdown, not a capability slide.
engagement
How AWS Clinical Trial Analytics Consulting Works With Kriv AI
Engagement Phases: Assessment, Pilot on Your Data, Production Hardening
A typical engagement starts with an assessment against your actual EDC, CTMS, and lab systems, moves to a pilot adapting this same five-agent architecture to a scoped subset of your trials, and hardens into production with your real 21 CFR Part 11 retention and electronic-signature requirements carried through from the accelerator's audit-trail design.
compliance
Built for GxP, 21 CFR Part 11, and HIPAA From Day One
Every agent invocation, data write, and electronic signature is hash-chained into the audit trail and mirrored to an Object Lock S3 bucket, the specific data-integrity pattern 21 CFR Part 11 requires. Protocol-deviation classification is mapped to ICH E6(R3) directly in the agent's own rules, and the platform runs entirely on public reference data and synthetic records, so it can be demonstrated and discussed freely without a BAA.
Straight answers
Frequently asked questions about Clinical Trial Analytics on AWS: A Working Accelerator, Not a Slide Deck
Is the clinical trial analytics accelerator a real, working system?
Yes. It's a deployed AWS environment with five Bedrock agents, Redshift Serverless, six Lambda functions, an AWS Glue Catalog, and a 21 CFR Part 11 audit-trail test suite that passes 6 of 6. It runs on public CDISC reference data and synthetic case report forms, not real PHI.
What five problems do the agents solve?
Enrollment forecasting, protocol deviation detection, adverse event narrative generation, submission readiness checking, and a 21 CFR Part 11 audit trail that hash-chains every agent action.
What does it cost to run?
Roughly $5 to $6 per month idle, $10 to $15 per day during an active demo, and about $55 to $90 for a full four-day deploy-demo-teardown cycle.
Is any real patient or trial data used?
No. The platform runs on the public CDISC SDTM Pilot dataset and locally generated synthetic case report forms. No PHI is used anywhere in the build.
How does this handle 21 CFR Part 11 compliance?
Every agent invocation, data write, and electronic signature is SHA-256 hash-chained and mirrored to a write-once-read-many S3 bucket, and the chain can be independently re-verified by any inspector in about 20 seconds.
Can we see this running before we engage Kriv AI?
Yes. We can walk through the live accelerator, including all five agents and the audit trail, in a discovery call.
Ready to see the accelerator run against your data model?
Bring your requirements to a working session and we'll walk through the live system.
Book a Discovery Call