New AI-powered solution automates document classification, metadata extraction, QC checks, and privacy protection to help sponsors and CROs achieve continuous inspection readiness.
Chicago, IL — February 02, 2026 — Cloudbyz, a leading provider of unified eClinical solutions built native on Salesforce, today announced the launch of the AI eTMF Agent, an advanced AI-powered intake and quality automation solution designed to streamline Trial Master File (TMF) operations for life sciences organizations. The new offering helps sponsors, CROs, and research sites accelerate study documentation, reduce manual workload, and maintain inspection-ready TMFs from day one.
The AI eTMF Agent leverages machine learning, OCR, natural language processing, and quality intelligence to automate document routing, classification, metadata capture, QC validation, and PII detection—while offering configurable human review and seamless integration with leading eTMF platforms, including Cloudbyz eTMF, Veeva Vault, and Medidata.
“A transformational leap for TMF operations.”
“As clinical trials become increasingly global and data-driven, TMF teams face immense pressure to ensure completeness, accuracy, and compliance across thousands of documents,” said Dinesh Sheshadri, CEO of Cloudbyz. “The AI eTMF Agent is designed to eliminate manual bottlenecks and ensure teams stay inspection-ready every day. This launch reflects our ongoing commitment to modernizing clinical operations with AI-first, scalable, and compliant solutions.”
A New Standard for eTMF Intake and Quality
The AI eTMF Agent brings together automated document processing and intelligent quality control to reduce effort, increase consistency, and improve regulatory readiness across clinical studies.
Key capabilities include:
- AI-based document classification into TMF zones, sections, and artifact types
- Automated metadata extraction, reducing manual data entry by up to 70%
- Real-time QC checks (signatures, dates, pagination, ALCOA+, completeness)
- PII/PHI detection & redaction routing to support global privacy compliance
- Human-in-the-loop review workspace with confidence scoring
- Seamless sync to leading eTMF systems with full audit trails
Transforming Operations for Sponsors and CROs
For Sponsors, the AI eTMF Agent provides stronger oversight, standardized TMF processes, early detection of quality issues, and improved inspection readiness across all studies.
For CROs, the solution enables increased operational efficiency, reduced processing costs, improved delivery timelines, and differentiated performance in proposal and bid-defense cycles.
Early pilot programs have shown significant impact, including:
- 50–70% reduction in manual metadata entry burden
- 30–50% faster TMF intake cycle times
- Dramatic reduction in misfiled artifacts and QC findings
- Stronger privacy and regulatory compliance through automated PII detection
Part of Cloudbyz’s Expanding AI Innovation Strategy
The AI eTMF Agent extends Cloudbyz’s broader AI Innovation Lab initiative, which includes AI-powered solutions for clinical operations, data management, pharmacovigilance, and regulatory intelligence. By leveraging Salesforce Agentforce, Google Vertex AI, and a multi-cloud AI architecture, Cloudbyz continues to invest in scalable, validated, and industry-ready AI capabilities across the eClinical ecosystem.
Availability
The AI eTMF Agent is available immediately as an add-on to Cloudbyz eTMF or as an integration-ready service for organizations using third-party eTMF systems.
Organizations interested in learning more or joining early AI programs can contact Cloudbyz at sales@cloudbyz.com.
About Cloudbyz
Cloudbyz is a global provider of unified, cloud-based eClinical solutions designed to accelerate clinical research and improve operational efficiency across life sciences. Built native on Salesforce, Cloudbyz offers a comprehensive suite covering CTMS, EDC, eTMF, RTSM, Safety & Pharmacovigilance, RBQM, Regulatory Intelligence, and AI-powered automation modules. Cloudbyz solutions support biopharma, medical devices, diagnostics, consumer health, and CROs worldwide.
For more information, visit www.cloudbyz.com.
Press Contact
Cloudbyz Communications
Email: marketing.team@cloudbyz.com
Website: www.cloudbyz.com
