HealthTech & BioTech • Life Sciences & Clinical Trial Management

Veeva Vault (eTMF, Quality, PromoMats, CTMS)

"Unified cloud suite for clinical trials, regulatory affairs, quality, and medical content"

Manages electronic Trial Master Files (eTMF), drug safety and pharmacovigilance, FDA regulatory submission dossiers, and commercial promotional compliance.

Engage Veeva Specialists ← Back to All Enterprise Apps

99.99%

Global Enterprise Adoption

15 Min

P1 Hypercare SLA

95%+

Automated Test Coverage

Zero

Production Outages Target

1. Custom Software Engineering & Integrations

Modernizing, extending, and integrating Veeva Vault (eTMF, Quality, PromoMats, CTMS) with cloud-native microservices.

Veeva Vault API custom connectors and webhook event processors
Automated clinical data ingestion pipelines from EDC (Medidata Rave) to Vault
Custom lifecycle actions, user role automation, and signature workflows
Bi-directional sync with enterprise ERP (SAP) and CRM (Salesforce)

2. 24/7 Managed Support, Observability & Hypercare

Continuous health monitoring, proactive tuning, and SLA-guaranteed incident resolution.

24/7 Global Study Support during active Phase I-IV clinical trials
Veeva General Release (tri-annual) regression validation and hypercare
User access administration and trial site provisioning

3. Full-Stack Quality Assurance & Security Matrix

Comprehensive functional, automated, load, and security test gates for Veeva Vault (eTMF, Quality, PromoMats, CTMS).

Manual & Workflow Validation:

FDA 21 CFR Part 11 electronic signature audit, Annex 11 validation, GxP document lifecycle verification.

Test Automation Engineering:

Automated Computer System Validation (CSV) / CSA test scripts using Playwright and Python REST test frameworks.

Performance, Load & Stress:

High-volume clinical document upload and rendering stress testing with k6.

Security, DevSecOps & Compliance:

Trial blinding validation, unblinded data access leak audits, SOC 2 compliance verification.

Proven Enterprise Impact

Case Study: Global Biotech Enterprise

The Challenge:

Manual validation of tri-annual Veeva Vault releases taking 6 weeks per cycle, delaying clinical submissions.

Our Solution:

Built automated Computer Software Assurance (CSA) regression pipeline with automated test evidence generation.

Demonstrated Result: Release validation time slashed by 78% with zero FDA inspection findings.

Verified Technology Stack & Tooling

JavaPythonVeeva REST APIPlaywrightk6AWS S3SonarQube

Veeva Vault (eTMF, Quality, PromoMats, CTMS)

1. Custom Software Engineering & Integrations

2. 24/7 Managed Support, Observability & Hypercare

3. Full-Stack Quality Assurance & Security Matrix

Case Study: Global Biotech Enterprise

Ready to Supercharge Your Veeva Ecosystem?