Anova Expands Platform With Launch of Next-Generation eTMF Solution for Sponsors, CROs, and Research Sites

• Next-generation AnovaOS^® document management, incorporating eTMF platform that combines eISFs, automated document completion and trial master file maintenance, workflow management, integrated eSignature, and in a single unified clinical operations environment
• Platform is free for investigative sites, accelerating adoption while reducing administrative burden for sponsors, CROs, and sites
• The 21 CFR Part 11 compliant solution delivers continuous Good Clinical Practice compliance, real-time collaboration, and streamlined workflow automation to accelerate study startup and ongoing trial execution.

LONDON & CHICAGO--(BUSINESS WIRE)--Anova Enterprises, Inc. (Anova), a leading technology-enabled Clinical Research Organization (CRO) focused on accelerating and reducing the cost of clinical development, today announced the launch of its next-generation electronic Trial Master File (eTMF) platform — a unified study document management solution designed to eliminate redundant tasks and administrative burden, improve compliance, and create frictionless collaboration between sponsors, CROs, and research sites.

Operational across more than 1,000 research sites and sponsors globally, AnovaOS^® is already delivering a more streamlined approach to the conduct of clinical trials. The addition of the new eTMF capability further expands the platform’s end-to-end workflow automation and compliance infrastructure.

Built specifically for the realities of decentralized and increasingly complex global studies, the platform combines document automation, integrated document completion workflows, native eSignature capabilities, and automated trial master file maintenance within a single connected environment.

“Clinical trial teams are overwhelmed by disconnected systems, manual reconciliation, and document bottlenecks that slow study startup and increase compliance risk,” said Martin Walsh, President at Anova. “We built this platform to modernize how sponsors and sites work together — with standardization and automation at the core, not added on later.”

The launch positions AnovaOS^® as a strong alternative to current sponsor facing trial master file (TMF) and investigator site files (ISF) and site facing clinical trial management systems (CTMS) by delivering a singular operational platform. Rather than doing work and documenting what was done, documentation is automatically maintained when work is performed.

Key differentiators include:

• Intelligent workflows guide users through document generation, completion, review, QC, approval, and filing — reducing manual follow-up and eliminating common TMF gaps.
• Embedded 21 CFR 11 compliant eSignature capabilities accelerate approvals and remove the need for disconnected third-party signature platforms.
• Sponsors, CROs, and sites can securely exchange, reconcile, and maintain essential study documents in real time through a unified workspace.
• Investigative sites can participate without licensing fees or complex onboarding processes, helping improve engagement and accelerate activation timelines.
• Automated filing logic, completeness tracking, and configurable QC workflows help ensure documents remain audit-ready throughout the study lifecycle.
• The platform consolidates study communication, document management, workflow automation, and compliance oversight into a single solution.

Industry demand for connected clinical operations platforms continues to grow as sponsors seek alternatives to fragmented legacy systems that create duplicate workstreams between sponsors and site.

“Sites study teams would rather consent, enroll and treat patients rather than spending the majority of their time having to manage a wide range of sponsor portals and disconnected systems,” added Chris Beardmore, CEO at Anova. “Our approach delivers a transformative approach where work performed is documented automatically in a single, simplified solution.”

Anova continues to invest in AnovaOS^® AI-driven automation capabilities, including predictive document tracking, automated reconciliation, metadata extraction, and risk-based quality management workflows. AnovaOS^® is available immediately for sponsors, CROs, and research sites globally.

To find out more, contact [e-mail].

About Anova

Anova Enterprises, Inc. (Anova) is technology enabled concierge research organization committed to accelerating clinical development for biopharmaceutical companies utilizing the company’s proprietary technology platform (AnovaOS^®). For more information, please visit www.anovaevidence.com.