Best Electronic Trial Master File (eTMF) Software
Electronic trial master file (eTMF) software is a specialized content management system that captures, stores, and manages all essential documents and images from a clinical trial. These solutions speed up content management via templates, mobile scanning, document classification, AI-powered automation, and approval workflows.
Organizations such as pharmaceutical and biotech companies that conduct regulated clinical trials need to maintain a TMF to comply with government regulatory requirements. By digitizing essential trial documents and content, an eTMF offers greater quality control and visibility over processes and documentation, making it easier to audit content throughout the trial lifecycle to ensure compliance is being met. Sites, sponsors, and contract research organizations (CROs) can collaborate in real-time on the TMF, track key metrics for study completion, share and migrate content, and search and filter data.
An eTMF supports clinical trial management software and electronic data capture (EDC) software by importing documents from both solutions, as well as automating the creation and filing of new documents using information stored in both.
To qualify for inclusion in the Electronic Trial Master File (eTMF) category, a product must:
- Provide pre-built and customizable TMF reference models, and allow specifications to be configured at the study, country, and site levels
- Track the status of all necessary trial documents from missing to completed stages and provide analytics
- Establish review and approval workflows
- Allow document authoring and collaboration between internal and external parties
- Comply with all relevant government regulatory requirements for clinical trials, such as 21 CFR Part 11, HIPAA, ANNEX 11, GxP, and GDPR
Best Electronic Trial Master File (eTMF) Software At A Glance
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- Pros and Cons
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Egnyte combines the power of cloud content management, data security, and AI into one intelligent content platform. More than 22,000 customers trust Egnyte to improve employee productivity, automate b
- Project Manager
- Assistant Manager
- Marketing and Advertising
- Construction
- 43% Small-Business
- 39% Mid-Market
16,327 Twitter followers
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- User Satisfaction
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Viedoc streamlines clinical trials with a powerful, web-based eClinical suite centered around EDC. Designed for efficiency, compliance, and seamless collaboration, our feature-rich platform accelerate
- Data Manager
- Associate Analyst
- Pharmaceuticals
- Research
- 42% Enterprise
- 39% Mid-Market
200 Twitter followers
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- User Satisfaction
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ResearchManager Clinical Research Suite Clinical Data Management: •EDC (Electronic Data Capture) •ePRO (electronic Patient-Reported Outcomes) •RTSM (Randomization and Trial Supply Management) •
- PhD student
- Researcher
- Hospital & Health Care
- Research
- 54% Enterprise
- 34% Small-Business
97 Twitter followers
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Vault Platform is a cloud platform built for regulated content management. From an electronic trial master file that study teams like to use, to an enterprise-wide quality system that scales globally
- Pharmaceuticals
- Biotechnology
- 47% Enterprise
- 27% Mid-Market
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- User Satisfaction
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Rated HIGHEST User Adoption by industry leaders, ACE is an easy to use, one-stop shop, Quality Management System. With NO EXTRA CHARGE for support, additional modules or even upgrades, we can save you
- Pharmaceuticals
- Biotechnology
- 59% Mid-Market
- 31% Small-Business
325 Twitter followers
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- User Satisfaction
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Kivo is the easiest-to-use compliant document and project management solution for Life Science companies, including Sponsors, CROs, Consultants, and Service Providers. Kivo's platform includes DMS, RI
- Biotechnology
- Pharmaceuticals
- 69% Small-Business
- 31% Mid-Market
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- User Satisfaction
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Medidata Rave is a cloud–based clinical data management system used to electronically capture, manage, and report clinical research data. It enables the user to record patient information (ie, visit,
- Hospital & Health Care
- Pharmaceuticals
- 54% Enterprise
- 27% Mid-Market
11,592 Twitter followers
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- User Satisfaction
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TrialKit is an advanced eClinical platform designed to simplify and streamline data collection and study management in clinical research. This comprehensive solution caters to the needs of sponsors, C
- Medical Devices
- 55% Small-Business
- 35% Mid-Market
284 Twitter followers
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Flex Databases eTMF offers a next-generation electronic Trial Master File (eTMF) solution designed to streamline document management and regulatory compliance for clinical trials. We elevate the eTMF
- 100% Small-Business
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Trialize offers an advanced automation platform for clinical trials, designed to improve study build times by a factor of four and reduce manual work by as much as 73% (comparing to market-leading CTM
- 100% Enterprise
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Agatha Clinical is an electronic master file (eTMF) application that connects all trial participants and processes in a single, cloud-based application. Leveraging the TMF Reference Model, Agatha Cli
- 100% Enterprise
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- Seller Details
Flex Databases is a secure, unified and compliant system specifically built for life sciences. All modules are validated and compliant with 21 CFR Part 11 and GxP requirements, and other global reg
- 100% Mid-Market
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- Seller Details
Florence software connects home health care data from outside the clinic with the healthcare community.
- 100% Small-Business
918 Twitter followers
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- 100% Mid-Market
6,354 Twitter followers
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Aurea Compliance Manager delivers end-to-end integrated solutions designed to address the specific workflow and compliance needs in the Life Sciences.
489 Twitter followers
