betterclinical is where life science companies find & evaluate software and technology solutions specifically for clinical research, 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 1.
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
Agatha Clinical is an electronic trial master file (eTMF) application that connects all trial participants and processes in a single, cloud-based application. Leveraging the TMF Reference Model, Agatha Clinical includes standard templates to help you get up and running quickly, reducing ramp-up time to hours and days instead of weeks or months.
With configurable actions that allow you to capture processes in end-to-end workflows, Agatha Clinical provides a tool to enforce best practices, document all activities, and connect all study participants. The result is faster start-up, more consistent processes, and complete trial documentation ready for inspection at any time.
About the company
Virtually all clinical and compliance solutions are based on traditional document management approaches. You know, check-in, check-out, yada yada. Agatha breaks the mold with better technologies to deliver a solution to manage end-to-end processes, not just documents.
Clinical trials and compliance processes are the bridge between developing new drugs, devices, and therapies and getting them to the patients who desperately need them. Every day managing trials and compliance activities mean another day before a new drug or treatment is available to patients.
Agatha founders set out to prove that a new class of cloud-first, ready-to-use applications could shorten the time required to get critical new drugs and treatments to patients.
Product Summary
Redefine Trial Master File management with ACM Electronic Trial Master File (eTMF). eTMF lets you ensure completion, compliance, and access for clinical Trial Master Files throughout the study lifecycle.
About the company
At Aurea, we often say that we are the “Netflix of business software.” This metaphor applies to our business model – customers have access to every product in our software portfolio – and our ambition. We don’t just sell software. We drive innovation by implementing targeted visions that benefit our customers’ businesses today and build the foundation for their success in the future.
We’re not afraid to go all in. We recognize that the future of work lives on the public cloud, and we invest accordingly. For our customers, that means more, faster digital transformation. It delivers unparalleled breadth and uncompromised security. It translates to economies of scale that we pass on to you as ongoing, tangible value.
Product Summary
BSI eTMF (electronic Trial Master File) offers a trend-setting interface and complete trial master file management functionality. It perfectly supports pharma, biotech, MedTech sponsors, as well as CRO and academics (SMO) in their daily work for trial master file management. BSI eTMF is always audit and inspection ready. If you are looking for an affordable yet powerful eTMF solution, BSI is the right partner for you.
About the company
Founded in 1996. Specializing in state-of-the-art software for life sciences. At home in Switzerland, Germany and USA, or wherever you would like us to be. Private ownership, with employees being part owners. No hierarchies. Our success is based on strong values, best in class products and first-rate employees. That’s who we are.
Product Summary
Ensure your Trial Master File is complete, timely, and accurate at all stages of a trial and across the document lifecycle with PhlexTMF. Our eTMF software is dedicated 100% to TMF best practices. PhlexTMF offers the industry’s only 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, Phlexglobal leverages our extensive TMF expertise and innovation to developing customer-driven, purpose-built eTMF technology with embedded best practices.
About the company
PharmaLex is now part of Cencora, a leading global pharmaceutical solutions organization centered on improving lives around the world.
PharmaLex adds to Cencora’s expanding suite of pharma solutions and serves the pharma, biotech, and medtech industries. We guide clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-elevated solutions to support clients through the entire product lifecycle.
Product Summary
Clinevo electronic Trial Master File (eTMF) has inbuilt DIA reference model and meets regulatory guidelines including:
About the company
Founded in 2016, we are a Software Development Company specialized in developing and implementing robust technology solutions for Life Sciences R&D. We help Pharma, Biotech and CROs in reducing their time and cost in Clinical trials by implementing innovative technologies that involves Data warehousing, Analytics, Collaboration, Automation, and Artificial Intelligence.
With our unique combination of domain experience & technology expertise, we are committed towards delivering the most efficient and the best practical end-to-end software solutions with HIPAA, GXP, CSV, 21 CFR Part 11 and other applicable regulatory guidelines. Our unmatchable domain experience and technology expertise enables us to deliver the best software solutions.
Product Summary
By integrating advanced technology with the specific needs of clinical trial management, ClinVigilant eTMF software offers an unparalleled tool for researchers. It enhances efficiency, ensures regulatory compliance, and facilitates seamless collaboration among all stakeholders in the clinical trial ecosystem. ClinVigilant eTMF © innovative software streamlines the organization, storage, and retrieval of essential trial documents, ensuring that every phase of the clinical trial process is documented, compliant, and easily accessible.
About the company
From decentralized trials to our clinical trial consulting services, our therapeutic, technical and functional team is underprop by the culture of ethics and patient safety. Our strong conviction and commitment is to our clients in bringing the next generation quality therapies faster to the market.
Our experts and developers can work on complex business challenges with your team to help you achieve your goals and define a roadmap of necessary changes, whether by implementing new solutions or transforming existing legacy processes
Product Summary
Cloudbyz eTMF solution offers a cloud-based repository of all your clinical trial documents including files, images, information, etc. Digitally capture, manage, share, and store all clinical trial-related documents with a centralized overview. Manage essential trial documents, stay inspection ready, and enable real-time visibility for CROs, sponsors, monitors, and other stakeholders in a clinical trial.
About the company
We launched Cloudbyz with a vision to reinvent enterprise applications for industry verticals. Encouraging and enabling our employees to have a positive social impact and put our customers and partners first is what helps make our clients wildly successful. Our deep expertise in the industries we serve ensures that our products and services delight our customers and transform their organizations.
Product Summary
TrialKit eTMF consolidates mission-critical documents in a central location for easy access for faster TMF delivery and study execution.
Manage your clinical trial documents in real-time for truly remote collaboration between sponsor, site, and CRO. Move away from error-prone paper- and spreadsheet-based processes. TrialKit’s eTMF system integrates with TrialKit EDC as well as external vendors in the cloud, ensuring your documents stay current, accurate, and inspection ready. TrialKit eTMF comes with a built-in template based on CDISC’s Trial Master File (TMF) Reference Model v. 3.3.1. Combined with the drag-and-drop functionality inherent in all TrialKit products, you can implement TrialKit eTMF in days, not weeks.
About the company
Crucial Data Solutions was founded in 2010 by a group of clinical technology experts to help drug and medical device companies get their products to market faster. By launching TrialKit, they created an alternative to high-cost, high-burden data collection and study management solutions on the market.
TrialKit was designed to address unmet needs for medtech, pharma and biotech sponsors and CROs looking for a more seamless, cost-effective solution.
To this day, Crucial Data Solutions remains laser-focused on its mission—to help our customers reclaim control and enhance the health and quality of life of their patients by delivering advanced, affordable clinical technology.
Product Summary
eTMF Made Easy for Biotechs
Assemble all critical trial documents in a cloud-based document management system that grants visibility into trial completeness, quality, and timelines, with built-in audit-readiness for regulatory review. Reduce the time spent on administration of site documentation, searching for and organizing documents, and submission preparation. Egnyte’s modular offerings grow with your company through all development and approval phases – from startup to scale up. Over 600 Life Sciences Customers Trust Egnyte.
About the company
Egnyte transforms businesses through smarter content allowing organizations to connect, protect, and unlock value from all their content. Our content governance platform delivers smart content collaboration and governance in the cloud or on-premises to thousands of businesses around the world even the most regulated industries. Founded in 2008, Egnyte is headquartered in Mountain View, CA. Investors include venture capital firms, such as Google Ventures and Kleiner Perkins Caufield & Byers, as well as technology partners, such as CenturyLink and Seagate Technology.
Product Summary
The Ennov eTMF is an electronic trial master file solution to collect and manage essential trial documents in a centralized repository and makes them available to clinical teams, via the internet, from any location at any time. The benefits of using Ennov eTMF include streamlined processes, increased transparency, simplified tracking and enhanced security.
Our eTMF leverages the power of our comprehensive Enterprise Document Management software and Business Process Management software. Features include:
These features provide all the functionality required to effectively and efficiently manage your clinical trial documentation. Ennov eTMF’s scalability and security enables you to safely manage large volumes of documents – making it the perfect solution for global deployments. Our TMF dashboards also help organizations decrease risk, increase efficiency, and improve quality.
About the company
Headquartered in Paris, with offices in the US, UK, and Asia, Ennov provides the most original, comprehensive and cost-effective suite of software solutions for the Life Sciences industry. We proudly serve over 250 companies and 250,000 users worldwide.
Our solutions are designed and built to support the entire Life Sciences R&D continuum. This includes Clinical, Regulatory, Quality, Pharmacovigilance and Commercial. Ennov boast a 100% success rate in customer audits.
We are recognized by Gartner as a global provider of software technology for the Life Sciences industry.
Our solutions enjoy extremely high user adoption rates, thanks to our intuitive user interfaces. We also have very high customer satisfaction ratings with an on-time project delivery rate of 98.5% and an annual maintenance renewal rate of 96%.
Product Summary
Stay on top of your trial with real-time access to study documentation using the EvidentIQ eTMF. Easy to use and easy to manage. Create your own workflows to route documents – eliminating tedious manual processes. eTMF filing is embedded within our CTMS to streamline processes. Provides a quick oversight into the quality, completeness and timeliness of your trial documentation. Use our dashboards or create your own to display study health and to monitor inspection readiness. Use EvidentIQ’s eTMF as a stand-alone eTMF or inherently integrated with the rest of our platform – providing a single sign-on for all your clinical trial software needs.
About the company
Leveraging more than 50 years of combined experience providing innovative and creative ways to conduct clinical trials we have achieved:
Product Summary
What sets Flex Databases apart?
Easy implementation: We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient involvement and requirements.
Complete data safety: We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world.
Full compliance: Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Flexible solution: Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.
About the company
Flex Databases was founded in 2011 and to this day remains privately owned by our working managers. Our HQ is in Prague, Czech Republic, with additional offices in Switzerland, the U.S., and Turkey and our clients are based all over the globe. About half are CROs, and half are sponsors including pharma companies, biotech, medical devices, and academic research.
Now, you are probably wondering about security, compliance, and validation. We provide truly comprehensive service, taking care of system roll out, implementation, data hosting, backups, security, as well as validation and compliance. We are GCP, GMP, HIPAA, GDPR compliant, have participated in numerous audits, and experienced helping clients during inspections.
Product Summary
Streamline TMF documents. Connect TMF to eISF. Accelerate close-out.
Get set up fast with the top-rated platform in ease-of-use, ease-of-setup, and customer support. Plus, connect directly to your sites with the only eTMF integrated with the industry-standard electronic investigator site file network. High Adoption: We lead the industry with 92%+ site technology activation per study.
Faster Timelines: Intuitive workflows that eliminate duplicate work mean work gets done fast.
Low FTE Burden: You don’t need large dedicated IT teams to support implementation and management.
About the company
Florence Healthcare is the leading provider of the Site Enablement Platform, committed to accelerating cures by better connecting sponsors, CROs, and research sites.
The company’s integrated platform streamlines the clinical trial process, enabling seamless collaboration and more efficient management of clinical research workflows. Florence Healthcare is dedicated to fostering innovation and improving patient outcomes worldwide with over 12,000 connected research sites on its platform in 45 countries, facilitating more than 6.5 million research workflows every month.
Product Summary
IQVIA eTMF streamlines day-to-day TMF document workflows, quality control (QC) checks, and finalizations for your clinical operations. Our IQVIA eTMF keeps everyone on the same page, maintains detailed audit trails and always prepared for health authority inspections. IQVIA’s electronic Trial Master File simplifies today’s over-engineered products and implementations, empowering oversight without busting the budget.
About the company
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We have approximately 86,000 employees, and conduct operations in more than 100 countries. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients.
View eTMF Software Part 2 or review the entire list in our eTMF clinical trial solutions directory.
