Late Phase Trials

eTMF – Electronic Trial Master File

eTMF is a secure, version-controlled Electronic Trial Master File designed to centralise and manage all clinical trial documentation within a single, inspection-ready environment. By automating document workflows and maintaining complete, time-stamped audit trails, eTMF reduces compliance risk, improves operational efficiency, and ensures rapid access to critical trial records across global studies.

Key Benefits

1

Document Control

Reduces the risk of missing, duplicate, or outdated documents through centralised management.

2

Review Efficiency

Speeds up document review, approval, and retrieval by eliminating manual handoffs and silos.

3

Inspection Readiness

Maintains continuous inspection readiness with complete, current, and traceable documentation.

4

Cost Optimisation

Lowers operational and storage costs by replacing paper-based and fragmented document systems.

5

Standardisation

Applies consistent documentation standards across studies and sites, aligned with regulatory expectations.

6

Compliance Confidence

Strengthens confidence in regulatory submissions and inspections with audit-ready trial records.

Services Section

Key Functionalities

Central Repository
Provides a single, secure repository for all clinical trial documents to ensure completeness and accessibility.
Workflow Automation
Automates document review and approval workflows to streamline collaboration and reduce cycle times.
Version Control
Maintains full document version history to ensure teams always work with the latest approved records.
Access Management
Applies role-based access and permission controls to protect document integrity and confidentiality.
Audit Trails
Captures complete, time-stamped audit trails for every document action to support regulatory compliance.
Status Reporting
Enables seamless collaboration between trial sites and CROs through shared, real-time supply visibility.
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faster document retrieval during audits and inspections

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reduction in document review and approval timelines

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accuracy in document version control through controlled version management

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traceability of audit trails across all trial documents

Let's understand how you manage your Late Phase Studies?