Electronic Trial Master File (eTMF) System

The Most Advance eTMF

The Trial Master File (TMF) is a structured collection of documents for a clinical trial to show evidence of regulatory compliance, allowing the conduct and quality of data collection to be evaluated. TMF contains study level, country level and site level documents, and those documents are collected at multiple points during the study (e.g. startup to study close). A related feature set, the electronic Investigator Site File (eISF) portal, can work in conjunction with your eTMF to facilitate document exchange between sponsor/CRO and sites.

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Features

Free up Your Internal TMF Resources

Leverage seasoned Trial Master File (TMF) Study Owners anytime anywhere. Obtain pragmatic training on TMF best practices & technology. Conduct efficient, accurate TMF migrations & imports at any scale.

Optimize Processes & Quality

Get a holistic view of completeness, timeliness & quality. Pinpoint & correct TMF completeness gaps. Embed TMF best practices around quality control & compliance. Obtain expert guidance for SOPs & eTMF technologies.

Make Your eTMF System Work For You

Align TMF technology with your people & processes. Leverage your eTMF to develop & automate better TMF workflows. Obtain hands-on, system-specific eTMF training.

TMF Completeness Heatmaps

Easily identify potential TMF problem areas in any eTMF system and enable a risk-based remediation approach.

TMF Quality Review

A thorough quality assessment of your TMF, giving you detailed insight into its quality and completeness.

TMF Document Processing

Ensure completeness, accuracy, and consistency from source to archive - regardless of your eTMF provider.

TMF Study Owners

Our TMF Practitioners have successfully mastered the challenges you and your teams face every day.

TMF Consulting Services

Our expert TMF consultants help your company reach and stay in the TMF Health Zone.

Migrations & Imports

Help ensure you are meeting GCP standards and regulatory requirements for essential documents.

TMF Expert Training

Generate lasting benefits to your team and improve the overall health of your TMF.

eTMF Health Dashboard

For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality. To achieve and maintain ongoing TMF health and inspection readiness – the “TMF Health Dashboard” – requires experienced people trained on effective processes using the right technology.

Full-Service Trial Master File Management

The Industry’s Only Turnkey, End-to-End TMF Outsourcing Solution from a Single Expert Provider.