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Healthcare & Life Sciences verified Verified Outcome TRL 9

Real-World Evidence (RWE) Data Commons

domain Client: A major biotechnology company handshake Provider: AWS / Internal schedule Deploy: Q3 2021 (Scale)
90 Impact
Enterprise Ready
Evidence Score: 5/10
Strength: High

Executive Summary

ANALYST: COI RESEARCH

To leverage Real-World Data (RWD) from hospitals and registries for drug development, the company built an 'Enhanced Data Commons'. This platform ingests messy external data, applies strict curation and harmonization governance (mapping to standard medical ontologies), and makes it available for analysis while adhering to strict patient privacy rules.

rate_review Analyst Verdict

"Turning chaos into evidence. External health data is notoriously dirty and unstandardized. The value here is the 'Data Curation' governance layer that harmonizes this data, making it regulatory-grade (FDA acceptable) for synthetic control arms in trials."

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Full Audit Report Available Includes Risk Register, Technical Specs & Compliance Data.

warning The Challenge

Clinical trials are expensive. Using existing hospital data (RWD) could speed up insights, but the data formats vary wildly between hospitals. Privacy rules prevent direct access. Scientists spent 80% of time cleaning data.

psychology The Solution

The platform ingests data into a secure zone. Automated pipelines map it to the OMOP (Observational Medical Outcomes Partnership) common data model. Governance policies enforce that only de-identified data can be accessed by researchers. Lineage tracking proves data origin to regulators.

settings_suggest Technical & Deployment Specs

Integrations
Flatiron Health, Foundation Medicine
Deployment Model
Cloud
Data Classification
RWD / PHI
Estimated TCO / ROI
High
POC Summary (2018-01-01 to 2019-01-01)

"N/A"

shield Risk Register & Mitigation

Risk Factor Severity Mitigation Strategy
Data Bias High Statistical analysis to re-weight populations.
Partner Stability Medium Diversified data sources (Flatiron, etc.).

trending_up Impact Trajectory

Audited value realization curve

Ingestion of millions of patient records Verified Outcome
Primary KPISupport for FDA regulatory submissions using RWE
Audit CycleReduction in clinical trial costs

policy Compliance & Gov

  • Standards: HIPAA, GxP
  • Maturity (TRL): 9
  • Evidence Score: 5/10
  • Data Class: RWD / PHI

folder_shared Verified Assets

description
Verified Case Study
PDF • Version 1
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Technical Audit
PDF • Audited
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Security Architecture

The "Blind Verification" Protocol

How we verified these outcomes for A major biotechnology company without exposing sensitive IP or identities.

Private
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1. Raw Evidence

Audit ID: #PRIV-875
Evidence: Direct SQL Logs
Public
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2. Verified Asset

Outcome: Verified
Ref ID: #COI-875

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