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Electronic Trial Master File Software Vendors for clinical trials
If you are involved in the management of clinical trials and are looking for a list of eTMF software vendors (electronic Trial Master File), then you are in the right place.
At betterclinical we work diligently to categorize all the major variations of software and technologies used to run and manage clinical trials. Hopefully we get it right. In the case of eTMF software, we have identified over 30 key eTMF solutions. We will update the list from time to time. What follows is a list of eTMF vendors part 2.
If you are interested in reviewing a list of multiple categories of clinical trial solutions, then please make your way to our Clinical Trials Solutions Directory.
An electronic trial master file (eTMF) is software designed to capture, collect, organize, store, manage, track, provide access and archive required and essential clinical trial documents. The eTMF is a digital or electronic version of the required trial master file (TMF).
The primary purpose of the eTMF is to provide a complete, error-free record of all essential documents and information related to a clinical trial.
eTMFs offer advantages over traditional paper-based TMFs in terms of efficiency, accessibility, security, and regulatory compliance and are becoming indispensable tools for efficient document management and seamless collaboration among those running clinical trials.
According to reports, the eTMF market is expected to show strong growth over the next decade. The continued growth of the global electronic trial master file (eTMF) market can be attributed to the growing number of clinical trials across the globe and the continued technology maturity of pharmaceutical companies and CROs to web-based applications.
For a more detailed look at eTMF software, please review the article titled: “What is eTMF Software“
For the sake of clarity:
This is not a review of each vendor’s solution. It is simply highlighting available eTMF software vendors.
Product Summary
Accelerate clinical trials and streamline TMF management with Kivo’s fully compliant, cloud-based eTMF System.
About the company
We’re a team of regulatory experts and software architects who came together to create a better document collaboration solution for today’s emerging life science teams.
Starting in 2012 with our original ‘Gemstone’ platform, we’ve been building our expertise working with fast-growing life sciences teams – and realized that these teams need a solution built specifically for their size, scale, and distributed way of working.
Product Summary
MasterControl eases TMF burdens. With the eTMF Manager™ solution, you gain real-time visibility into the status of all clinical activities. Based on the TMF Reference Model, the solution simplifies the management of all the documents, tasks, milestones and activities that are required during a clinical trial. It’s inherently problematic to manage tons of TMF documentation with a paper-based system. That’s why leaders turn to proven software systems to manage TMF processes. Digitization provides a superior, efficient approach to TMF management. Our proven eTMF solution increases visibility into clinical trials. It also digitally integrates TMF activities with other compliance-critical functions.
About the company
Over 25 years and 1000 plus customers, at MasterControl, customer success is the core value on which we base our entire business operating philosophy. We take great pride in our innovative solutions, but we take even greater pride in helping some of the most trusted, well respected leaders in the life sciences and manufacturing industries put that innovation to work throughout their organizations to bring amazing products to life.
Product Summary
Rave eTMF (electronic Trial Master File) is a collaboration platform that streamlines creating, managing, and populating clinical trial content.
Rave eTMF simplifies clinical document filing by auto-populating TMF content, so that your TMF is always contemporaneous with the trial. Unlike other TMF solutions on the market, Rave eTMF is easily deployed with minimal IT involvement, with an implementation timeline as short as 8 weeks.
About the company
More than 20 years ago, Medidata was founded with the hope of powering smarter treatments and healthier people. Today, Medidata leads the digital transformation of life sciences, creating hope for millions of patients. We help generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers.
Product Summary
eTMF Connect goes beyond simply improving inspection readiness to improving the entire inspection experience. Its intuitive interface means that you’ll be able to train an inspector in the system in no time, saving you valuable hours and alleviating unnecessary stressors during an inspection.
• Centralized records centre allows for seamless review by regulatory agencies
• Cloud-based and globally accessible to remove friction
• Specialized inspector portal enables easy system access
• Easily apply filters to help navigate the TMF
About the company
Montrium is a global leader in cloud-based records, submissions, and quality management solutions and GxP consulting services for the life sciences. We help organizations implement and maintain technology to improve their business processes and increase compliance. Delivering our powerful content management solutions across the globe, we serve thousands of users in over 20 countries.
At Montrium we believe in providing the best possible products and services, and our ability to understand the unique needs of each customer is the reason why our customers continue to return to us every time. We work together as a team to always put our customers first, focusing on close collaboration between our clients and our team members. Our transparent approach towards any new opportunity has allowed us to create bonds of trust with some of the largest players in the life sciences industry.
Product Summary
As opposed to a traditional eTMF, myClin updates all your key study documents and interactions instantaneously. Use your eTMF as an efficient study management tool instead of a simple repository. Build a perfectly organized, inspection-ready eTMF. Optimize document creation by allowing the author to distribute and correctly code items as they go along – cutting out later reconciliation tasks. Documents can appear on one or both the TMF and an ISF simultaneously, as controlled by the author. All stakeholders can access the latest study materials when they need them with automatic proof they have accessed the correct versions.
About the company
myClin is the leading Software as a Service (SaaS) platform for essential Clinical Trial Compliance and Oversight. It allows for secure document exchange between sites, sponsors and CROs, automatically tracked study communications, centralized and accelerated study training, and unique Compliance Scoring insights.
The myClin Compliance Score gives all study stakeholders the ability to identify and measure hidden study compliance gaps. You can track and improve the readership of essential study documents and the delivery of critical study updates and training. It provides clear and objective metrics for all stakeholders to stay inspection-ready and ensure continuous and contemporaneous oversight.
Since 2008 our mission has been to leverage technology to enhance oversight, compliance, engagement and collaboration in clinical trials. The team of clinical research veterans that created myClin brought deep experience delivering clinical operations services and building feature-rich eClinical systems. Since then, myClin has been used across all phases of research, in global bio-pharmaceutical and device studies with thousands of clinical users.
Product Summary
Deploy a highly effective eTMF solution to electronically capture, organize, share, and store all those essential documents, images, and artifacts that arise during the lifecycle of a regulated clinical trial. Now organize your content in a recognized taxonomy and structure with built-in checklists and milestone tracking features. Access a flexible wizard-driven process for setting up eTMF – table of contents (TOI), document templates, metadata, and other parameters, allows the user to accurately customize the TMF filing plan with study-specific documents. The plan once configured can be further saved as a reusable template.
About the company
Octalsoft is a market leader in the field of eclinical solutions, IT consulting, custom software development, app development, digital transformation, and technology consulting. Established in 2007, Octalsoft sports over a decade of experience and a team of 60+ experts who have delivered consistent success with over 30000 platform users and a clientele spread across 22 countries. Here is glimpse of how we reached where we are today.
Product Summary”
Simplify regulatory compliance and improve efficiency.Our eTMF (Electronic Trial Master File) web-based system helps to streamline the trial process and ensure that all relevant information is readily available to relevant stakeholders. As regulatory requirements continue to evolve managing clinical trial documentation has become an increasingly critical and complex process.
With our eTMF solution, you can efficiently replace paper-based processes and manual document handling. Our secure and user-friendly platform enables seamless collaboration, simplifies audit trails, and ensures compliance with regulatory standards.
Whether you’re conducting clinical trials, managing research data, or overseeing regulatory submissions, eTMF provides the tools you need to stay ahead.
About the company
Promeditec was established with the aim of simplifying the use of information technology in the field of clinical research and education, offering innovative and efficient solutions.
We promote the development of our clients through the adoption and development of innovative tools and specialized consulting services in the areas of clinical research, implementation of online training programs, and organization of events.
Product Summary
The RegDoc365 eTMF includes:
About the company
RegDocs365 came about as a result of the collaboration between Court Square Group hosting a submission processing environment for eSubmissionSolutions. The founders, Keith Parent from Court Square Group and Antoinette Azevedo from eSubmissionSolutions had been working together for a number of years. Recognizing the significance of the environment that Antoinette was using for her client base we decided that this would be a great offering for small to mid-size companies looking to do their own Regulatory filings. By replicating the environment for other Regulatory customers we were able to have our first regulatory offerings featuring the DIA EDM and eTMF reference model.
Product Summary
Support for DIA reference models, SimpleTrials reference model, or build your own eTMF model
Define site essential documents required for activation, study closure, and EC submission
Ability to upload files directly to the CTMS with 21 CFR Part 11 compliant electronic signatures
Manage tracking details such as common name, version, and status or build your own columns
Expiration tracking with role-based and person-specific alerts
Ability to track study-specific and other general documents by study
Approved electronic visit reports (EVRs) and attachments automatically posted to eTMF
Zip download available for posted files including organizational view
Tracking and folder views plus document search feature for ease of navigation
CTMS Reports for essential documents, folders, change history and custom tracking fields
About the company
Trial By Fire Solutions specializes in eClinical software solutions, focusing on clinical trial management systems within the life sciences industry. The company offers SimpleTrials, a secure, scalable, and affordable on-demand Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) that caters to sponsors, Contract Research Organizations (CROs), and clinical trial sites. SimpleTrials is designed to support specialized studies or a full portfolio of trials, ensuring compliance and providing a subscription-based pricing model.
Product Summary
Mentor eTMF clinical trial software can get up and running quickly and efficiently. Built on the same platform as Mentor CTMS and available with affordable add-on pricing, it maximizes value, minimizes headaches, and meets all regulatory requirements, with support for the most recent DIA Reference Model, 21 CFR Part 11 compliance, or a complete audit trail.
Sitero eTMF has been successfully used by leading Sponsors and CROs and proven across thousands of clinical trials worldwide.
About the company
Sitero is a next-generation, site-focused clinical research organization (CRO) for life sciences and institutional research organizations that helps get treatments to market safer and faster through tech-forward services that streamline research. Accelerate your clinical trial, drive compliance and safety, and unlock innovation with access to powerful technology and world-class services. Sitero combines the expertise of a tenured team with a nimble, innovative approach to clinical research. Sitero has offices in the U.S., U.K., and India.
Product Summary
Designed by and for Clinical Operations professionals, SureETMF™ is a cloud-based regulatory content management application for electronic trial master file ( ETMF ) documents and DICOM medical image management. With FDA Part 11 compliance validation, SureETMF automates the capture, digital completion, signing, classification and tagging of content via collaborative portals. Designed to be easily used from any device, clinical trial stakeholders can collaboratively view, share, digitally esign, comment on and manage content from mobile, web or desktop.
About the company
SterlingBio is a leading provider of cloud-native Eclinical Applications that are open, connected, smart and easy to use. Life science companies in Biotech, Pharma, Clinical Research, Medical Devices and Medical Research choose SureClinical to accelerate, streamline, and automate clinical trial and quality management processes everywhere. Our Eclinical Ecosystem empowers internal and external teams to break free from vendor lock-in by connecting applications, data and intelligence on our collaborative and compliant Eclinical Platform.
Product Summary
The Electronic Trial Master File (eTMF) allows the sponsor to organise the archiving of study documents in accordance with the regulations in force.
The eTMF module allows:
• The maintenance of a repository of all types of documents that can be collected during the study. This repository is based on the model established by the Drug Information Association (DIA) and is available for download
• The configuration, for each study, of the types of documents to be collected and the generation of the list of expected documents The eTMF module allows:
• The maintenance of a repository of all types of documents that can be collected during the study. This repository is based on the model established by the Drug Information Association (DIA) and is available for downloadable
• The configuration, for each study, of the types of document to be collected and the generation of the list of expected documents
About the company
Telemedicine Technologies is the publisher of e-Health solutions, market leader in the field of Clinical Research with its CleanWeb™ solution, a secure Internet platform dedicated to the electronic management of clinical trials and registries.
By subscribing to our solution in SaaS mode or a project-based approach, you choose a flexible e-Platform and can opt for the applications and services: eCRF, CTMS, eTMF, eConsent, Medical Imaging, rSDV Monitoring, Vigilance, Randomisation, Managed Access Programmes (MAP) that you require… Our bespoke solution can be tailored to meet any clinical trial phase, size and complexity.
Product Summary
The world’s only global, multilingual, full-service TMF Solutions provider and home of the world’s first and only accredited TMF University. Thousands of studies worldwide pass inspections with confidence leveraging the world’s highest concentration of TMF expertise. Our AI-powered eTMF empowers every stakeholder – from study managers and CRAs, to IT teams and business leadership – to be more compliant. By streamlining TMF compliance, TI eTMF removes the friction from day-to-day clinical operations. Learn how you can ensure quality, completeness, and timeliness with an electronic trial master file.
About the company
TransPerfect Life Sciences offers global content solutions for the pharmaceutical, biotech, and medical device industries. With industry experts, specialists (like TMF, COA, medical writing, and marketing, among many others), certified linguists, and advanced technology, we accelerate the commercialization process for life sciences companies from lab through launch. Trust TransPerfect for precise, efficient, and cost-effective global content solutions.
TransPerfect’s Trial Interactive is an industry leader in practical, global eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world.
Product Summary
Leading trial master file application
Veeva Vault eTMF is the leading trial master file application used to ensure the quality, timeliness, and completeness of a TMF.
Enterprise content management capabilities
It provides full enterprise content management capabilities for upload, version control, QC and approval, and real-time co-authoring with Microsoft Office for study documents such as consent forms. It’s highly efficient and performant and supports global outsourcing.
Compliance and collaboration workflows
Completeness and timeliness are managed through Expected Document Lists (EDLs). Content files are auto-classified through the TMF Bot, and classified content is matched automatically to EDLs. The TMF Transfer feature simplifies exchange between sponsors and CROs by sending completed TMFs at study close.
About the company
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 875 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Canada, Europe, Asia, and Latin America.
Product Summary
Viedoc TMF is our fully integrated document management system—highly secure and with 24/7 accessibility. Based on industry standards and equipped with permissions, document review, and a customizable structure, Viedoc TMF makes documentation easier, smoother, and above all: faster.
About the company
For two decades, we have perfected the craft of making clinical data more accessible so that greater discoveries can happen sooner.
At Viedoc, we believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.
Since 2003, Viedoc has united scientists and clinical trial professionals in a shared mission of pushing life-changing research forward. Our solution has been used to power thousands of studies, by collecting data from over a million patients and allowing it to flow smoothly across sites and countries. We take great pride in helping bridge the gap between patient and researcher—and, in the best of cases, between research and breakthrough.
Product Summary
Securely access your trial master file from anywhere, anytime, and on any device. Always know the status of all your clinical documents, enable collaboration, and ensure eTMF quality and completeness. Full support for the TMF Reference model. Supports the documents, properties, relationships, and hierarchies of the TMF Reference Model for both core and recommended documents. Create collaborative documents supporting live edit, suggestions and full audit trial. Upload existing files or create a placeholder.
About the company
Zapclinica helps you provide telemedicine and automate decentralized clinical trials
From small medical practices in need of telehealth to large global healthcare companies conducting decentralized clinical trials across the globe.
View eTMF Software Part 1 or review the entire list in our eTMF clinical trial solutions directory.
