How Venova Medical Improved Clinical Documentation and Collaboration Using Orcanos

The Challenge
With multiple clinical sites contributing to shared documents, Venova Medical needed:

• An electronic master file (eTMF) structure to archive and manage trial documentation;
• Workflows for documents requiring administrator signatures and documents requiring multi-user approvals;
• Underlying metadata fields, versioning, and full audit-trail functionality, to ensure each document update was traceable and compliant.
• Compliance and regulation alerts and notifications to maintain the file data integrity.
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‍The Orcanos Approach
Orcanos’ Document Control module was configured to meet the above needs:

• We defined and implemented a Trial Master File (TMF) structure tailored to Venova Medical’s use case.
• Custom templates and metadata fields were created to capture required information, and workflows were defined to support both admin-only and multi-user e-signature paths.
• A dedicated training environment was provided, with hands-on sessions for users and administrators.
• Administrative operations were configured to enable the dynamic management of users, metadata values, and system tables, allowing for complete control over document taxonomy, revisioning, and access rights.
  
  

This deployment delivered a single-source electronic repository with audit-ready traceability, enabling collaboration across sites while preserving compliance.

The Results
Post-implementation, Venova Medical achieved:

• Streamlined multi-site collaboration on shared documents via a unified eTMF.
• Automated signature workflows differentiated by approval paths.
• Real-time tracking of document status, expiration dates, revision history, and signatures.
• Thanks to traceability and structured document control, improved data integrity, reduced manual overhead, and enhanced audit readiness.
  
  

Why Venova Medical Chose Orcanos
Venova Medical selected Orcanos because of its flexibility in fitting their custom workflows and user-friendly interface that didn’t compromise compliance demands. They needed a system that didn’t force them to adapt to rigid processes but instead accommodated their own trial operations while ensuring traceability, metadata control, and audit readiness.

A Satisfied Customer
Venova Medical remains an active user of Orcanos. Their clinical operations team reports increased control, streamlined collaboration across users, and confidence in their document system’s audit-ready posture.

Next Step

Venova Medical plans to expand the eTMF implementation to other future projects.

Lesson Learned
For organizations running clinical trials across multiple sites, a robust eTMF/document control system must deliver more than storage,  it must enable metadata-driven organization, signature workflows, version and revision control, and full audit-trail traceability. Implementing such a system allows you to shift from a fragmented, manual process to a streamlined, compliant, and collaboration-enabled environment.

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