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HealthTech & BioTech • Electronic Data Capture (EDC) & Clinical Trials

Medidata Rave EDC & Clinical Cloud

"Unified clinical trial electronic data capture, randomization, and trial supply management"

The world's leading electronic data capture and clinical trial operations platform capturing real-world clinical patient data, site randomization, and trial supply tracking.

Engage Medidata 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 Medidata Rave EDC & Clinical Cloud with cloud-native microservices.
  • Medidata Web Services (WSAPI) custom integrations with SAS/R data pipelines
  • eCOA / ePRO patient diary mobile application companion development
  • Wearable biosensor and decentralized clinical trial (DCT) telemetry pipelines
  • Automated ODM-XML and CDISC SDTM data transformation microservices

2. 24/7 Managed Support, Observability & Hypercare

Continuous health monitoring, proactive tuning, and SLA-guaranteed incident resolution.
  • 24/7 Site Support for global clinical trial investigators across 100+ countries
  • Trial mid-study protocol amendment migration hypercare
  • Audit trail preservation and database freeze/lock administration

3. Full-Stack Quality Assurance & Security Matrix

Comprehensive functional, automated, load, and security test gates for Medidata Rave EDC & Clinical Cloud.
Manual & Workflow Validation:
Complex CRF edit checks, adverse event (AE) reporting rules, and investigator electronic signature verification.
Test Automation Engineering:
Automated test harness with Python & Playwright testing hundreds of dynamic CRF conditional branches.
Performance, Load & Stress:
High-volume batch data transfer stress testing during multi-site trial enrollment surges.
Security, DevSecOps & Compliance:
FDA 21 CFR Part 11 data integrity testing, blind-breaking security controls, and HIPAA audits.
Proven Enterprise Impact

Case Study: Top-5 Global Oncology CRO

The Challenge:

Phase III oncology trial study build and mid-study protocol changes delayed patient recruitment.

Our Solution:

Automated custom edit check validation with automated test evidence generators compliant with GAMP 5.

Demonstrated Result: Study build timeline cut from 12 weeks to 3 weeks with 100% regulatory audit pass rate.
Verified Technology Stack & Tooling
PythonJavaCDISC ODMREST APIsPlaywrightk6AWS

Ready to Supercharge Your Medidata Ecosystem?

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