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Biotechnology verified Verified Outcome TRL 9

Unified Clinical Cloud

domain Client: A global biotechnology company handshake Provider: Veeva Systems schedule Deploy: 2022
85 Impact
Enterprise Ready
Evidence Score: A/10
Strength: High

Executive Summary

ANALYST: COI RESEARCH

Unification of Clinical Data Management (CDM) and Clinical Operations on a single cloud platform to accelerate trial execution.

rate_review Analyst Verdict

"Low Risk. Veeva is the industry standard 'operating system' for life sciences. Unifying CDM and Ops eliminates the fragile integrations between EDC and CTMS."

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

warning The Challenge

Managing complex clinical trials for cystic fibrosis therapies involved disparate systems for data capture (EDC) and trial management (CTMS). Data reconciliation was manual and slowed database lock.

psychology The Solution

Adopted the full Veeva Vault Clinical Suite. This unified study startup, eTMF (Trial Master File), and EDC (Electronic Data Capture) on one platform.

settings_suggest Technical & Deployment Specs

Integrations
HRIS / Finance
Deployment Model
SaaS
Data Classification
Clinical Data / IP
Estimated TCO / ROI
High
POC Summary ( to )

"N/A"

shield Risk Register & Mitigation

Risk Factor Severity Mitigation Strategy
Vendor Concentration Low Strategic partnership

trending_up Impact Trajectory

Audited value realization curve

Reduced study startup time Verified Outcome
Primary KPIFaster database lock at trial end
Audit CycleSingle source of truth for trial documents

policy Compliance & Gov

  • Standards: GxP / 21 CFR Part 11
  • Maturity (TRL): 9
  • Evidence Score: A/10
  • Data Class: Clinical Data / IP

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 global biotechnology company without exposing sensitive IP or identities.

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1. Raw Evidence

Audit ID: #PRIV-539
Evidence: Direct SQL Logs
Public
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2. Verified Asset

Outcome: Verified
Ref ID: #COI-539

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