Clinical Trial Analytics + 21 CFR Part 11 Audit Trail on AWS — 8 Weeks

Stand up a Part 11-defensible clinical trial analytics platform on AWS in 8 weeks — not 8 months.

Kriv AI's 8-week deployment lands Redshift, SageMaker, Bedrock (with Guardrails), CloudTrail, Lake Formation, S3 Object Lock WORM, and KMS as a cohesive clinical trial analytics stack inside your AWS account. We deploy, validate, and hand over operations with a documented runbook, a hash-chained audit trail that supports ALCOA+ evidence, and Bedrock-drafted narratives that always pass through documented human review.

Why biotech, pharma, and CROs engage Kriv AI

AI/ML is entering clinical operations faster than validation frameworks. EDC-adjacent analytics, enrollment forecasting, risk-based monitoring (RBM), and safety signal detection increasingly run on cloud data platforms — but most are not built with a 21 CFR Part 11-aligned ERES foundation from day one. FDA's Dec 2024 final PCCP guidance for AI-enabled device software, plus ICH E6(R3) Good Clinical Practice (Jan 2025), raise the bar. The result: analytics that work in a notebook but fail on inspection.

What we deploy

Redshift clinical data warehouse — SDTM-aligned staging, study-scoped schemas, role-based views SageMaker pipelines — enrollment forecasting (site/country), RBM risk scoring, protocol deviation classifiers, dropout prediction Amazon Bedrock agents with Guardrails — patient safety narratives, CSR section drafts, deviation summaries, signal-detection triage. Every Bedrock output is routed through documented human review by a qualified medical or clinical reviewer before use — drafts are evidence, not decisions. CloudTrail + S3 Object Lock (WORM) + KMS hash-chained audit trail — immutable, cryptographically signed, 6-year retention aligned to ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) Lake Formation row and column-level access control for PHI/PII fields QuickSight dashboards — 5 views: Enrollment Velocity, RBM Risk Heatmap, Safety Signal Review Queue, Protocol Deviations, Part 11 Audit Trail Monitor Validation input templates — URS/FRS stubs, traceability matrix, IQ/OQ/PQ scaffolds, ALCOA+ control map. Customer's QA team executes formal CSV.

8-week engagement. Weeks 1–2 Design (intended-use, GAMP 5 categorization, BAA/NDA, EDC/CTMS/eTMF/lab feeds, ALCOA+ gap, IAM + Lake Formation, Part 11 control map). Weeks 3–5 Build (Redshift + SDTM staging, Glue ETL medallion, SageMaker training + registry, Bedrock with human-review gating, hash-chained audit trail). Weeks 6–7 Evals + validation (QuickSight, UAT with ClinOps + QA, MITRE ATLAS red-team, Part 11 audit-trail validation, ALCOA+ walkthrough, validation input template delivery). Week 8 Cutover (production go-live, runbook, knowledge transfer to ClinOps + QA + IT, 30-day hypercare).

Three tiers. Starter ($75K) for single-study biotechs / small CROs / investigator-led: 1 study + 2 SageMaker pipelines + 2 Bedrock narrative agents + 1 dashboard + Part 11 hash-chained audit trail. Professional ($100K) for mid-market biotechs / CROs with 3–10 active studies: 3 studies + 4 pipelines + 4 agents + 3 dashboards + EDC integration (Medidata Rave / Veeva Vault EDC / Oracle Clinical) + PCCP scaffolding. Enterprise ($150K) for pharma sponsors / top-tier CROs: 5 studies + 6 pipelines + 5 agents + 5 dashboards + multi-EDC + multi-tenant Lake Formation for partner CRO access + PCCP submission-ready package + 30-day hypercare. Optional Extra Study Integration ($25K each).

Important disclosures. AWS infrastructure costs billed separately by AWS. Kriv prepares implementation, configuration, validation input templates, and methodology only. Kriv does NOT execute formal CSV, sign validation protocols, make regulatory submissions, or provide clinical/medical/legal advice. No Part 11 certification exists. Bedrock outputs require documented human review by qualified medical/clinical staff before any regulatory, clinical, or safety use. Customer retains BAA, clinical trial data, regulatory filings, and operational responsibility post-handover. "21 CFR Part 11" used for identification only; no FDA endorsement implied. "Anthropic" and "Claude" are trademarks of Anthropic PBC; Anthropic does not endorse this specific solution.