Best Electronic Trial Master File (eTMF) Software

Emma Stein
ES
Researched and written by Emma Stein

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
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Best Electronic Trial Master File (eTMF) Software At A Glance

Leader:
MasterControl Quality Management System
MasterControl Quality Management System
Highest Performer:
Viedoc
Viedoc
Easiest to Use:
Egnyte
Egnyte
Top Trending:
Viedoc
Viedoc
Best Free Software:
Viedoc
Viedoc
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G2 takes pride in showing unbiased reviews on user satisfaction in our ratings and reports. We do not allow paid placements in any of our ratings, rankings, or reports. Learn about our scoring methodologies.

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35 Listings in Electronic Trial Master File (eTMF) Available
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MasterControl Quality Management System

(506)4.3 out of 5
Entry Level Price:Contact Us
3rd Easiest To Use in Electronic Trial Master File (eTMF) software
OverviewPros and Cons
Product Description

MasterControl Quality Excellence is the #1 Quality Management System (QMS) in life sciences. Built on an AI-driven platform, it enables life-sciences companies to enable flexible quality event managem

Users: Quality Assurance Specialist, Quality Engineer · Industries: Pharmaceuticals, Medical Devices · Market Segment: 65% Mid-Market, 25% Enterprise
Pros and ConsUser Satisfaction
ProsEase of Use, Document Management, Training, Document Control, Features
ConsLearning Curve, Not Intuitive, Difficult Usability, Complex Setup, Not User-Friendly
User SatisfactionSeller Details
MasterControl Quality Management System features and usability ratings that predict user satisfaction
7.8
Ease of Use
Average: 8.9
8.6
Quality of Support
Average: 8.3
Seller Details
Year Founded
1993
HQ Location
Salt Lake City, UT
Company Website
https://www.mastercontrol.com?utm_source=linkedin&utm_medium=about&utm_campaign=l1nk3din-sm
Twitter
@MCMasterControl
LinkedIn® Page
https://www.linkedin.com/company/23070/

Egnyte

(1,142)4.4 out of 5
Entry Level Price:Contact Us
1st Easiest To Use in Electronic Trial Master File (eTMF) software
OverviewPros and Cons
Product Description

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

Users: Project Manager, Owner · Industries: Construction, Marketing and Advertising · Market Segment: 44% Small-Business, 38% Mid-Market
Pros and ConsUser Satisfaction
ProsEase of Use, File Sharing, Easy Sharing, Security, Easy Access
ConsExpensive, File Management, Limited Features, User Difficulty, Lacking Features
User SatisfactionSeller Details
Egnyte features and usability ratings that predict user satisfaction
9.0
Ease of Use
Average: 8.9
8.8
Quality of Support
Average: 8.3
Seller Details
Year Founded
2008
HQ Location
Mountain View, CA
Company Website
https://www.egnyte.com
Twitter
@Egnyte
LinkedIn® Page
https://www.linkedin.com/company/1015589/
Phone
650-968-4018
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Veeva Vault

(52)4.1 out of 5
OverviewUser Satisfaction
Product Description

Veeva Vault is a cloud-based platform specifically designed for the life sciences industry, integrating content and data management to streamline complex processes across research and development (R&a

Industries: Pharmaceuticals, Biotechnology · Market Segment: 46% Enterprise, 27% Mid-Market
User SatisfactionSeller Details
Veeva Vault features and usability ratings that predict user satisfaction
7.7
Ease of Use
Average: 8.9
8.6
Quality of Support
Average: 8.3
Seller Details
Year Founded
2007
HQ Location
Pleasanton, CA
Company Website
https://www.veeva.com
Twitter
@veevasystems
LinkedIn® Page
https://www.linkedin.com/company/402048/
Ownership
NYSE: VEEV

Viedoc

(263)4.5 out of 5
Entry Level Price:Contact Us
2nd Easiest To Use in Electronic Trial Master File (eTMF) software
OverviewPros and Cons
Product Description

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

Users: Data Manager, Associate Analyst · Industries: Pharmaceuticals, Research · Market Segment: 39% Enterprise, 33% Mid-Market
Pros and ConsUser Satisfaction
ProsEase of Use, User Interface, Intuitive, Customer Support, Design Ease
ConsSlow Performance, Difficulty, Access Control, Form Design Issues, Missing Features
User SatisfactionSeller Details
Viedoc features and usability ratings that predict user satisfaction
9.2
Ease of Use
Average: 8.9
9.2
Quality of Support
Average: 8.3
Seller Details
Year Founded
2003
HQ Location
Uppsala, Uppsala County
Company Website
https://www.viedoc.com/
Twitter
@ViedocOfficial
LinkedIn® Page
https://www.linkedin.com/company/viedoctechnologies/

Clinical Research Suite

(205)3.8 out of 5
Entry Level Price:Pay As You Go
OverviewPros and Cons
Product Description

ABOUT ResearchManager is an all-in-one platform that makes clinical research smarter, faster, and more efficient. With the Clinical Research Suite, we provide a fully integrated solution for academic

Users: PhD student, Researcher · Industries: Hospital & Health Care, Research · Market Segment: 55% Enterprise, 33% Small-Business
Pros and ConsUser Satisfaction
ProsEase of Use, Interface Clarity, User Interface, Features, Data Management
ConsPoor Navigation, Missing Features, Difficulty, Slow Performance, Data Management Issues
User SatisfactionSeller Details
Clinical Research Suite features and usability ratings that predict user satisfaction
7.5
Ease of Use
Average: 8.9
7.6
Quality of Support
Average: 8.3
Seller Details
Year Founded
2013
HQ Location
Deventer, Overijssel
Company Website
https://my-researchmanager.com/
Twitter
@RESEARCH_MGR
LinkedIn® Page
https://www.linkedin.com/company/research-manager/

ACE

(29)4.7 out of 5
Entry Level Price:Contact Us
OverviewPros and Cons
Product Description

Rated HIGHEST User Adoption by industry leaders, ACE is an easy to use, one-stop shop, Quality Management System. We can save you more money than your current provider. Offering everything from Do

Industries: Pharmaceuticals, Biotechnology · Market Segment: 59% Mid-Market, 31% Small-Business
Pros and ConsUser Satisfaction
ProsBusiness Growth, Customer Support, Ease of Use, Easy Learning, Efficiency
User SatisfactionSeller Details
ACE features and usability ratings that predict user satisfaction
9.6
Ease of Use
Average: 8.9
9.2
Quality of Support
Average: 8.3
Seller Details
Year Founded
2009
HQ Location
Pomona, CA
Company Website
https://pscsoftware.com/
LinkedIn® Page
https://www.linkedin.com/company/psc-software/
Phone
1-828-237-8767

Kivo

(17)5.0 out of 5
Entry Level Price:Contact Us
OverviewPros and Cons
Product Description

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

Industries: Biotechnology, Pharmaceuticals · Market Segment: 71% Small-Business, 29% Mid-Market
Pros and ConsUser Satisfaction
ProsEase of Use, Implementation Ease, User Interface, Customer Support, Customization
ConsFeature Limitations, Missing Features, UX Improvement
User SatisfactionSeller Details
Kivo features and usability ratings that predict user satisfaction
9.8
Ease of Use
Average: 8.9
9.6
Quality of Support
Average: 8.3
Seller Details
Year Founded
2021
HQ Location
Portland, US
Company Website
https://kivo.io
LinkedIn® Page
https://www.linkedin.com/company/kivoio

Flex Databases eTMF

(7)4.1 out of 5
OverviewUser Satisfaction
Product Description

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

Market Segment: 57% Small-Business, 14% Mid-Market
User SatisfactionSeller Details
Flex Databases eTMF features and usability ratings that predict user satisfaction
8.0
Ease of Use
Average: 8.9
9.0
Quality of Support
Average: 8.3
Seller Details
Year Founded
2011
HQ Location
Prague, CZ
Company Website
https://www.flexdatabases.com
LinkedIn® Page
https://www.linkedin.com/company/2394870

TrialKit

(26)4.6 out of 5
OverviewPros and Cons
Product Description

TrialKit is a unified eClinical platform designed to simplify and streamline data collection and study management in clinical research. This end-to-end solution caters to the needs of sponsors, CROs,

Industries: Medical Devices · Market Segment: 58% Small-Business, 35% Mid-Market
Pros and ConsUser Satisfaction
ProsCustomer Support, Ease of Use, Features, User Interface, Access Ease
ConsDifficulty, Inadequate Reporting, Limitations, Limited Flexibility, Slow Performance
User SatisfactionSeller Details
TrialKit features and usability ratings that predict user satisfaction
8.7
Ease of Use
Average: 8.9
9.3
Quality of Support
Average: 8.3
Seller Details
Year Founded
2010
HQ Location
Reno
Company Website
https://www.crucialdatasolutions.com/
Twitter
@Crucial_Data
LinkedIn® Page
https://www.linkedin.com/company/crucial-data-solutions-inc/

Medidata Rave

(27)4.7 out of 5
OverviewPros and Cons
Product Description

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,

Industries: Hospital & Health Care, Pharmaceuticals · Market Segment: 52% Enterprise, 26% Mid-Market
Pros and ConsUser Satisfaction
ProsData Management, Easy Integrations
ConsExpensive, Login Issues
User SatisfactionSeller Details
Medidata Rave features and usability ratings that predict user satisfaction
9.5
Ease of Use
Average: 8.9
9.0
Quality of Support
Average: 8.3
Seller Details
Year Founded
1999
HQ Location
New York, NY
Company Website
https://www.medidata.com
Twitter
@Medidata
LinkedIn® Page
https://www.linkedin.com/company/12076/

Flex Databases CTMS

(3)4.5 out of 5
OverviewUser Satisfaction
Product Description

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

Market Segment: 33% Mid-Market, 33% Small-Business
User SatisfactionSeller Details
Flex Databases CTMS features and usability ratings that predict user satisfaction
10.0
Ease of Use
Average: 8.9
10.0
Quality of Support
Average: 8.3
Seller Details
Year Founded
2011
HQ Location
Prague, CZ
Company Website
https://www.flexdatabases.com
LinkedIn® Page
https://www.linkedin.com/company/2394870

Trialize

(2)4.5 out of 5
OverviewPros and Cons
Product Description

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

Market Segment: 100% Enterprise
Pros and ConsUser Satisfaction
ProsEase of Use, Efficiency, Time-saving
User SatisfactionSeller Details
Trialize features and usability ratings that predict user satisfaction
10.0
Ease of Use
Average: 8.9
7.5
Quality of Support
Average: 8.3
Seller Details
Year Founded
2020
HQ Location
Zug, CH
Company Website
https://trialize.io
LinkedIn® Page
http://linkedin.com/company/trialize

Agatha Clinical eTMF

(1)3.5 out of 5
OverviewUser Satisfaction
Product Description

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

Market Segment: 100% Enterprise
User SatisfactionSeller Details
Agatha Clinical eTMF features and usability ratings that predict user satisfaction
8.3
Ease of Use
Average: 8.9
0.0
Quality of Support
Average: 8.3
Seller Details
Company Website
https://www.agathalife.com/
LinkedIn® Page
http://www.linkedin.com/company/agatha-bijoux

Florence eTMF

(1)5.0 out of 5
OverviewUser Satisfaction
Product Description

Florence software connects home health care data from outside the clinic with the healthcare community.

Market Segment: 100% Small-Business
User SatisfactionSeller Details
Florence eTMF features and usability ratings that predict user satisfaction
0.0
No information available
0.0
No information available
Seller Details
Year Founded
2014
HQ Location
Atlanta, Georgia
Company Website
https://florencehc.com/
Twitter
@FlorenceHCare
LinkedIn® Page
https://www.linkedin.com/company/florence-healthcare/

Aurea Compliance Manager

0 ratings
OverviewUser Satisfaction
Product Description

Aurea Compliance Manager delivers end-to-end integrated solutions designed to address the specific workflow and compliance needs in the Life Sciences.

User SatisfactionSeller Details
Aurea Compliance Manager features and usability ratings that predict user satisfaction
0.0
No information available
0.0
No information available
Seller Details
Year Founded
2012
HQ Location
Austin, TX
Company Website
https://www.aurea.com/
Twitter
@AureaSoftware
LinkedIn® Page
https://www.linkedin.com/company/2923561/
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