Cencora solution

PhlexTMF Enterprise

The industry's only complete eTMF solution with AI capabilities ready on day one to improve TMF quality and reduce inspection risk
Available for
  • Pharma
Available in
  • Global
Related capabilities
  • Drug research and clinical development support

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Driven by customers, built by the TMF authority

Ensure your Trial Master File is complete, timely, and accurate at all stages of a trial and across the document lifecycle with PhlexTMF, eTMF software dedicated 100% to TMF best practices. PhlexTMF offers a pre-trained AI solution that reduces document misfiles and metadata errors at the critical document upload step - immediately improving TMF quality and reducing inspection risk.

Unlike eClinical “platforms” or generic electronic content management systems built for other industries, Cencora leverages our extensive TMF expertise and innovation to develop customer-driven, purpose-built eTMF technology with embedded best practices.

Cencora’s combination of global TMF practitioners, quality management professionals, and technologies build customer-driven insight into innovative eTMF software. The result? You gain authoritative, real-time intelligence and management control over the completeness, timeliness, and quality of your TMF—whether managed internally or outsourced to a CRO—along with the ability to easily identify gaps and take corrective action.

This Privacy and Data Protection Assurance Statement serves to inform and assure our customers, sponsors, and partners that the AI-assisted indexing functions embedded in our Trial Master File (TMF) system are fully compliant with global privacy and data protection laws, as well as emerging artificial intelligence (AI) regulatory frameworks. Our commitment to data protection is integral to the ethical and lawful handling of clinical trial documentation and participant-related data. PhlexTMF AI Privacy Statement

Key PhlexTMF features and benefits

AI tips at upload

Prevent document filing errors before they occur with suggestions based on millions of documents and the embedded guidance of TMF experts - improving TMF quality and reducing inspection risk.

Simplified study setup

Capture what is unique about a trial with study setup questions which are able to address specific trial parameters and document requirements, while still enforcing filing standards.

TMF data exchange

Easily transport your TMF between organizations and systems, ensuring order to the interchange of your TMF content, metadata, audit trail, and e-signature information.

Intuitive user interface

A simple interface with a unique combination of tree and search navigation which offers flexible document location options which are preferred by auditors and inspectors.

eTMF event management

Capture study changes such as protocol amendments that affect expected documents, plus track collection and quality control event stories to verify completion.

Intelligent placeholders

Define where documents are expected which drives completeness metrics; simplify uploads by removing the need to fill in numerous fields for every document.

Oversight and reporting

User-configured dashboards dynamically filter results and can use heatmap visualization to show TMF timeliness and quality.

TMF quality review

PhlexTMF Quality Review tools let you quickly and easily conduct regular, risk-based, or milestone-driven completeness reviews.

Process management

Flexible workflows help designate the path of a Trial Master File document from upload all the way through to inspection readiness.

eQuery tracking system

Identify, communicate, and track remediation of Trial Master File issues, eliminating multiple communication paths and capturing all relevant information in one place.

Completeness workflows

Easily and visually identify missing documents with views that show documents received vs expected in real-time across trial, country, site, zone, vendor, and more.

A comprehensive TMF management system

Much more than transactional eTMF software, with PhlexTMF you also gain a comprehensive TMF management system with executive overview, pragmatic visibility for study project leads, and embedded TMF intelligence.
Complete solution
Provides a complete solution for managing TMF processes throughout the study life cycle, from initial planning and study startup to closeout, inspection, and final archive.
Intuitive design
Embeds TMF best practices in an intuitive design so that you and your team can master the software quickly and easily, obtaining business value from day one.
Efficient workflows
Allows for easy configuration of the software to align with your own workflows and best practices, or to embed more efficient workflows due to organizational improvements.
Advanced tech
Delivers software releases incorporating industry-driven TMF best practices, while leveraging business-enabling technology advances such as machine learning and natural language processing (NLP).

Related resources

Webinar

Implementing risk-based quality review for an inspection-ready TMF
Learn more

Factsheet

Migrate your TMF
Learn more

Case study

From liability to asset: A TMF rescue
Learn more
 

Connect with our TMF experts to learn more

Get in touch to learn about how our solutions can help accelerate better health outcomes. Whether you have questions or just need more information, our experts are here to assist you.
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At Cencora, we understand that effective Trial Master File (TMF) management is a cornerstone of successful clinical trial execution, regulatory inspection readiness, and long-term document governance. As a global provider of TMF services, we are fully committed to ensuring that all personal data processed within our TMF platforms and services complies with applicable privacy and data protection laws worldwide. TMF Solutions Global Privacy Statement