# Best Electronic Trial Master File (eTMF) Software

  *By [Emma Stein](https://research.g2.com/insights/author/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](https://www.g2.com/categories/clinical-trial-management) and [electronic data capture (EDC) software](https://www.g2.com/categories/electronic-data-capture-edc) 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

- **Leader:** [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews)
- **Highest Performer:** [Viedoc](https://www.g2.com/products/viedoc/reviews)
- **Easiest to Use:** [Egnyte](https://www.g2.com/products/egnyte/reviews)
- **Top Trending:** [Viedoc](https://www.g2.com/products/viedoc/reviews)
- **Best Free Software:** [Viedoc](https://www.g2.com/products/viedoc/reviews)


## Top-Rated Products (Ranked by G2 Score)
  ### 1. [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews)
  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 management, simplified document management, and automated training management—that all work seamlessly together to close the loop on quality. Targeted primarily at quality professionals within the life sciences industry, MasterControl Qx serves a diverse range of organizations, from pharmaceuticals to biotechnology and medical devices. These industries often face stringent regulatory requirements and complex quality assurance processes. MasterControl Qx offers a centralized platform that integrates various quality management functions, allowing users to manage quality events, documentation, training, and audits seamlessly. This integration not only enhances operational efficiency but also ensures that organizations remain compliant with industry standards. One of the standout features of MasterControl Qx is its intelligent automation capabilities. By automating routine quality management tasks, organizations can reduce manual errors and free up valuable time for quality professionals to focus on more strategic initiatives. Additionally, the platform provides robust data insights that empower users to make informed decisions based on real-time information. This data-driven approach enhances the ability to identify trends, monitor compliance, and drive continuous improvement within quality processes. Furthermore, MasterControl Qx is designed to foster collaboration across departments and teams. The platform's connected nature allows for easy sharing of information and documentation, ensuring that all stakeholders are aligned and informed. This collaborative environment not only enhances communication but also supports a culture of quality throughout the organization. By utilizing MasterControl Qx, companies can create a more agile and responsive quality management system that adapts to changing regulatory landscapes and market demands. Overall, MasterControl Quality Excellence (Qx) stands out in the QMS category by providing a holistic solution tailored to the specific needs of the life sciences industry. Its combination of intelligent automation, robust data insights, and collaborative features positions it as a valuable tool for organizations striving to maintain high-quality standards while navigating the complexities of regulatory compliance.


  **Average Rating:** 4.3/5.0
  **Total Reviews:** 505

**User Satisfaction Scores:**

- **Ease of Use:** 7.8/10 (Category avg: 8.9/10)
- **Quality of Support:** 8.6/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [MasterControl](https://www.g2.com/sellers/mastercontrol)
- **Company Website:** https://www.mastercontrol.com?utm_source=linkedin&utm_medium=about&utm_campaign=l1nk3din-sm
- **Year Founded:** 1993
- **HQ Location:** Salt Lake City, UT
- **Twitter:** @MCMasterControl (6,274 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/23070/ (782 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Who Uses This:** Quality Assurance Specialist, Quality Engineer
  - **Top Industries:** Pharmaceuticals, Medical Devices
  - **Company Size:** 65% Mid-Market, 25% Enterprise


#### Pros & Cons

**Pros:**

- Ease of Use (129 reviews)
- Document Management (96 reviews)
- Training (71 reviews)
- Document Control (51 reviews)
- Features (48 reviews)

**Cons:**

- Learning Curve (47 reviews)
- Not Intuitive (47 reviews)
- Difficult Usability (38 reviews)
- Complex Setup (32 reviews)
- Not User-Friendly (32 reviews)

  ### 2. [Egnyte](https://www.g2.com/products/egnyte/reviews)
  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 business processes, and safeguard critical data, in addition to offering specialized content intelligence and automation solutions across industries, including architecture, engineering, and construction (AEC), life sciences, and financial services.


  **Average Rating:** 4.5/5.0
  **Total Reviews:** 1,115

**User Satisfaction Scores:**

- **Ease of Use:** 9.0/10 (Category avg: 8.9/10)
- **Quality of Support:** 8.8/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Egnyte](https://www.g2.com/sellers/egnyte)
- **Company Website:** https://www.egnyte.com
- **Year Founded:** 2008
- **HQ Location:** Mountain View, CA
- **Twitter:** @Egnyte (16,159 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/1015589/ (1,281 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Who Uses This:** Project Manager, Owner
  - **Top Industries:** Construction, Marketing and Advertising
  - **Company Size:** 44% Small-Business, 38% Mid-Market


#### Pros & Cons

**Pros:**

- Ease of Use (119 reviews)
- File Sharing (69 reviews)
- Easy Sharing (52 reviews)
- Security (46 reviews)
- Easy Access (44 reviews)

**Cons:**

- Expensive (21 reviews)
- File Management (18 reviews)
- Limited Features (13 reviews)
- Lacking Features (12 reviews)
- User Difficulty (12 reviews)

  ### 3. [Veeva Vault](https://www.g2.com/products/veeva-vault/reviews)
  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&D), regulatory affairs, quality management, and commercial operations. By unifying documents and structured data within a single system, Vault enhances collaboration, ensures compliance, and accelerates product development cycles. Key Features and Functionality: - Unified Content and Data Management: Vault manages both documents and structured data, providing a single source of truth that eliminates information silos and enhances data integrity. - Agentic AI Integration: The platform incorporates built-in agentic AI, enabling the creation and configuration of AI agents that operate within Veeva applications, facilitating intelligent automation and decision-making. - Configurable Workflows: Users can automate business processes with customizable workflows, including task assignments, notifications, and escalations, to improve operational efficiency. - Compliance and Validation: Vault is designed to meet rigorous compliance standards, offering features like audit trails, electronic signatures, and validation processes to ensure adherence to industry regulations. - Scalable Cloud Architecture: The platform's cloud-native design supports global scalability, allowing organizations to adapt to evolving business needs and performance requirements. Primary Value and Solutions Provided: Veeva Vault addresses the challenges of managing complex, regulated processes in the life sciences sector by offering a unified platform that integrates content and data management. This integration enhances collaboration among internal teams and external partners, ensures compliance with industry regulations, and accelerates product development and commercialization. By providing a scalable, configurable, and secure environment, Vault enables organizations to improve operational efficiency, reduce time-to-market, and maintain high standards of quality and compliance.


  **Average Rating:** 4.1/5.0
  **Total Reviews:** 51

**User Satisfaction Scores:**

- **Ease of Use:** 7.6/10 (Category avg: 8.9/10)
- **Quality of Support:** 8.7/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Veeva](https://www.g2.com/sellers/veeva)
- **Year Founded:** 2007
- **HQ Location:** Pleasanton, CA
- **Twitter:** @veevasystems (6,111 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/402048/ (9,716 employees on LinkedIn®)
- **Ownership:** NYSE: VEEV

**Reviewer Demographics:**
  - **Top Industries:** Pharmaceuticals, Biotechnology
  - **Company Size:** 45% Enterprise, 28% Mid-Market


  ### 4. [Viedoc](https://www.g2.com/products/viedoc/reviews)
  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 accelerates research and simplifies data collection, management, and analysis. Trusted in 75+ countries, Viedoc powers 7,000+ studies with more than 1.6M+ participants, bringing life-changing treatments to market faster.


  **Average Rating:** 4.5/5.0
  **Total Reviews:** 214

**User Satisfaction Scores:**

- **Ease of Use:** 9.2/10 (Category avg: 8.9/10)
- **Quality of Support:** 9.2/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Viedoc Technologies](https://www.g2.com/sellers/viedoc-technologies)
- **Company Website:** https://www.viedoc.com/
- **Year Founded:** 2003
- **HQ Location:** Uppsala, Uppsala County
- **Twitter:** @ViedocOfficial (200 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/viedoctechnologies/ (127 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Who Uses This:** Data Manager, Associate Analyst
  - **Top Industries:** Pharmaceuticals, Research
  - **Company Size:** 39% Enterprise, 33% Mid-Market


#### Pros & Cons

**Pros:**

- Ease of Use (38 reviews)
- User Interface (31 reviews)
- Intuitive (23 reviews)
- Customer Support (22 reviews)
- Design Ease (21 reviews)

**Cons:**

- Slow Performance (13 reviews)
- Difficulty (11 reviews)
- Access Control (8 reviews)
- Form Design Issues (8 reviews)
- Missing Features (7 reviews)

  ### 5. [Clinical Research Suite](https://www.g2.com/products/clinical-research-suite/reviews)
  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 institutions, healthcare organizations, CROs, and sponsors across the entire clinical research lifecycle. From study setup and regulatory approval to recruitment, data capture, and monitoring. By centralizing processes and data on a single platform, ResearchManager reduces complexity, minimizes errors, and enhances compliance and collaboration. OUR MISSION Our mission is to digitalize, accelerate, and optimize research worldwide, enabling innovative treatments and scientific insights to reach patients sooner. We believe advancing healthcare starts with advancing research, and we empower organizations to make that happen. OUR PLATFORM - THE CLINICAL RESEARCH SUITE Clinical Data Management: Tools to recruit the right participants and efficiently capture, manage, and validate research data, reducing errors and saving time. Includes: • Electronic Data Capture (EDC) • Electronic Patient-Reported Outcomes (ePRO) • Randomization and Trial Supply Management (RTSM) • Electronic Informed Consent (eConsent) Clinical Operations: Tools that centralize submissions, documentation, and workflows to streamline trial management and strengthen collaboration. These are all modular and fully configurable. Includes: • Clinical Trial Management System (CTMS) • Electronic Trial Master File (eTMF) • Regulatory Information Management System (RIMS) LEARN MORE • Request a FREE Demo:https://my researchmanager.com/en/request-inquiry/ • Get a Price Estimate in 1 Minute: https://my-researchmanager.com/en/pricing/


  **Average Rating:** 3.8/5.0
  **Total Reviews:** 204

**User Satisfaction Scores:**

- **Ease of Use:** 7.5/10 (Category avg: 8.9/10)
- **Quality of Support:** 7.6/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [ResearchManager](https://www.g2.com/sellers/researchmanager)
- **Year Founded:** 2013
- **HQ Location:** Deventer, Overijssel
- **Twitter:** @RESEARCH_MGR (96 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/research-manager/ (18 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Who Uses This:** PhD student, Researcher
  - **Top Industries:** Hospital & Health Care, Research
  - **Company Size:** 55% Enterprise, 33% Small-Business


#### Pros & Cons

**Pros:**

- Ease of Use (79 reviews)
- Interface Clarity (18 reviews)
- User Interface (18 reviews)
- Features (17 reviews)
- Data Management (14 reviews)

**Cons:**

- Poor Navigation (24 reviews)
- Missing Features (15 reviews)
- Difficulty (14 reviews)
- Slow Performance (10 reviews)
- Data Management Issues (8 reviews)

  ### 6. [ACE](https://www.g2.com/products/psc-software-ace/reviews)
  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 Document Management, Office 356 integration, to Inspection Management, we have thousands of monthly users that trust ACE. Cloud-based software that can be personalized to your highly regulated company, big or small, reach out today for a free demo!


  **Average Rating:** 4.7/5.0
  **Total Reviews:** 28

**User Satisfaction Scores:**

- **Ease of Use:** 9.6/10 (Category avg: 8.9/10)
- **Quality of Support:** 9.2/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [PSC Software](https://www.g2.com/sellers/psc-software-a5cc8bb4-e2ee-4814-80aa-3a1e9e3eb3dd)
- **Year Founded:** 2009
- **HQ Location:** Pomona, CA
- **LinkedIn® Page:** https://www.linkedin.com/company/psc-software/ (19 employees on LinkedIn®)
- **Phone:** 1-828-237-8767

**Reviewer Demographics:**
  - **Top Industries:** Pharmaceuticals, Biotechnology
  - **Company Size:** 59% Mid-Market, 31% Small-Business


#### Pros & Cons

**Pros:**

- Business Growth (1 reviews)
- Customer Support (1 reviews)
- Ease of Use (1 reviews)
- Easy Learning (1 reviews)
- Efficiency (1 reviews)


  ### 7. [Kivo](https://www.g2.com/products/kivo/reviews)
  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, RIM, QMS, and eTMF functionality. CFR Part 11 Compliant e-Sign | Lifetime Validation | ISO 9001 Certified | SOC 2 Certified | TMF & EDM Reference Models | GxP Compliant ▶ For Regulatory • Customizable, automatic authoring, review, QC, and approval workflows • Real-time collaboration online or locally in Office 365 • Smart document placeholders, with pre-formatted ICH templates available • Assemble submissions from pre-built submission structures aligned to country guidelines • Create automated tracking spreadsheets for external publishing groups ▶ For Quality • Controlled document and SOP management that meets GxP standards • Training management linked directly to documents in the DMS • Build curricula for teams or individual users with documents, videos, and quizzes • Auto-fill quality forms with metadata • Manage change controls, CAPAs, Deviations, Audits, and Vendors ▶ For Clinical • Workflows mapped to the TMF reference model • Accelerate active trial management, from study start up and beyond • Migrate TMFs into the system in weeks, including recompiled audit trails • Real-time reporting into TMF completeness • Long-term TMF storage at a fraction of the typical cost, with automatic checksums to ensure data integrity • Separate inspector access to help streamline your trial narrative


  **Average Rating:** 5.0/5.0
  **Total Reviews:** 17

**User Satisfaction Scores:**

- **Ease of Use:** 9.8/10 (Category avg: 8.9/10)
- **Quality of Support:** 9.6/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Kivo](https://www.g2.com/sellers/kivo)
- **Company Website:** https://kivo.io
- **Year Founded:** 2021
- **HQ Location:** Portland, US
- **LinkedIn® Page:** https://www.linkedin.com/company/kivoio (40 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Top Industries:** Biotechnology, Pharmaceuticals
  - **Company Size:** 71% Small-Business, 29% Mid-Market


#### Pros & Cons

**Pros:**

- Ease of Use (7 reviews)
- Implementation Ease (6 reviews)
- User Interface (5 reviews)
- Customer Support (4 reviews)
- Customization (4 reviews)

**Cons:**

- Feature Limitations (1 reviews)
- Missing Features (1 reviews)
- UX Improvement (1 reviews)

  ### 8. [Flex Databases eTMF](https://www.g2.com/products/flex-databases-etmf/reviews)
  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 experience beyond traditional systems by incorporating cutting-edge Artificial Intelligence (AI) technology, alongside a unique "co-pilot" feature that empowers human oversight. Effortless Filing and Enhanced Accuracy with AI Our AI assistant automates document classification and metadata assignment, significantly reducing manual effort and saving valuable time for clinical trial professionals. Co-Pilot Control While AI automates tasks, human oversight remains crucial. Our innovative "co-pilot" feature bridges the gap, allowing users to maintain control and expertise throughout the process. Users can set confidence levels for automatic classification by the AI. Documents falling below this designated threshold require user review. Additionally, the co-pilot feature empowers users to review and potentially adjust the AI's classifications. This user interaction allows the AI to continuously learn and improve its performance over time. Benefits of Flex Databases eTMF with AI and Co-Pilot: Effortless Efficiency AI streamlines document processing, freeing up valuable time for clinical trial professionals to focus on higher-level activities. Unmatched Accuracy The combined power of AI classification and co-pilot control minimizes errors, ensuring data integrity and unwavering regulatory compliance. Enhanced User Experience The intuitive interface and co-pilot feature create a user-friendly document management environment. Continuous Learning System User interaction with the co-pilot feature fosters continuous learning for the AI, resulting in ever-increasing classification accuracy.


  **Average Rating:** 4.1/5.0
  **Total Reviews:** 7

**User Satisfaction Scores:**

- **Ease of Use:** 8.0/10 (Category avg: 8.9/10)
- **Quality of Support:** 9.0/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Flex Databases](https://www.g2.com/sellers/flex-databases)
- **Year Founded:** 2011
- **HQ Location:** Prague, CZ
- **LinkedIn® Page:** https://www.linkedin.com/company/2394870 (67 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Company Size:** 57% Small-Business, 14% Mid-Market


  ### 9. [TrialKit](https://www.g2.com/products/trialkit/reviews)
  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, and clinical sites by providing a suite of tools that includes electronic data capture (EDC), electronic patient-reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), eConsent, medical coding, AI study intelligence, and more. With its web-based interface and a native mobile app, TrialKit allows users to securely collect, manage, and analyze study data from virtually anywhere, enhancing the flexibility and accessibility of clinical research. Targeted at clinical researchers and organizations conducting studies of varying sizes and complexities, TrialKit is particularly beneficial for those looking to expedite their research processes without sacrificing compliance or data integrity. The platform’s intuitive drag-and-drop form builder enables users to create and deploy regulatory-compliant studies quickly, eliminating the need for extensive programming knowledge. This feature has made TrialKit a preferred choice for over 9,000 studies across diverse therapeutic areas, showcasing its adaptability and user-friendly design. A core differentiator of the platform is TrialKit AI, recognized with the 2024 SCDM Innovation Award for Health Technology Solutions. TrialKit AI extends the platform with embedded intelligence powered by Floyd, enabling teams to go beyond traditional reporting and analytics. Capabilities include conversational data exploration, advanced analytics, full study simulation, and protocol validation—allowing users to model study outcomes, evaluate design decisions, and identify risks earlier in the trial lifecycle. TrialKit AI can also ingest external datasets, providing a broader foundation for analysis and enabling more informed, data-driven decisions across studies. By embedding these capabilities directly within the platform, TrialKit AI supports faster insights, more efficient study execution, and improved decision-making without requiring separate systems or tools. This integrated approach reduces operational complexity while enhancing the ability of research teams to proactively manage study performance. TrialKit’s emphasis on unified workflows and operational efficiency translates into meaningful cost savings for organizations. By centralizing data collection, management, and analysis within a single platform, TrialKit reduces reliance on fragmented systems and minimizes manual processes. As clinical research continues to evolve, TrialKit provides a flexible and scalable solution that supports modern study designs while maintaining a strong foundation in data integrity, compliance, and usability.


  **Average Rating:** 4.6/5.0
  **Total Reviews:** 24

**User Satisfaction Scores:**

- **Ease of Use:** 8.7/10 (Category avg: 8.9/10)
- **Quality of Support:** 9.3/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Crucial Data Solutions](https://www.g2.com/sellers/crucial-data-solutions)
- **Year Founded:** 2010
- **HQ Location:** Reno
- **Twitter:** @Crucial_Data (289 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/crucial-data-solutions-inc/ (16 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Top Industries:** Medical Devices
  - **Company Size:** 58% Small-Business, 35% Mid-Market


#### Pros & Cons

**Pros:**

- Customer Support (7 reviews)
- Ease of Use (5 reviews)
- Features (2 reviews)
- User Interface (2 reviews)
- Access Ease (1 reviews)

**Cons:**

- Difficulty (2 reviews)
- Inadequate Reporting (2 reviews)
- Limitations (2 reviews)
- Limited Flexibility (2 reviews)
- Slow Performance (2 reviews)

  ### 10. [Medidata Rave](https://www.g2.com/products/medidata-rave/reviews)
  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, lab, and adverse event data) using forms that are customized for each study.


  **Average Rating:** 4.7/5.0
  **Total Reviews:** 25

**User Satisfaction Scores:**

- **Ease of Use:** 9.5/10 (Category avg: 8.9/10)
- **Quality of Support:** 9.0/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Medidata](https://www.g2.com/sellers/medidata)
- **Year Founded:** 1999
- **HQ Location:** New York, NY
- **Twitter:** @Medidata (11,526 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/12076/ (2,801 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Top Industries:** Hospital & Health Care, Pharmaceuticals
  - **Company Size:** 52% Enterprise, 26% Mid-Market


#### Pros & Cons

**Pros:**

- Data Management (1 reviews)
- Easy Integrations (1 reviews)

**Cons:**

- Expensive (1 reviews)
- Login Issues (1 reviews)

  ### 11. [Flex Databases CTMS](https://www.g2.com/products/flex-databases-ctms/reviews)
  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 regulations. Our system consists of modules that cover clinical, quality and compliance, safety, as well as project and finance management, from project start-up to product production and post marketing Flex Databases CTMS offers a modular design, allowing you to tailor it to your specific trial needs. You can choose only the modules you require and have the flexibility to add or remove them as your trial progresses. For deployment options, Flex Databases CTMS caters to both cloud-based and on-premise preferences.


  **Average Rating:** 4.5/5.0
  **Total Reviews:** 3

**User Satisfaction Scores:**

- **Ease of Use:** 10.0/10 (Category avg: 8.9/10)
- **Quality of Support:** 10.0/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Flex Databases](https://www.g2.com/sellers/flex-databases)
- **Year Founded:** 2011
- **HQ Location:** Prague, CZ
- **LinkedIn® Page:** https://www.linkedin.com/company/2394870 (67 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Company Size:** 33% Mid-Market, 33% Small-Business


  ### 12. [Trialize](https://www.g2.com/products/trialize/reviews)
  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 CTMS). The platform is particularly well-suited to modern, decentralized, and virtual studies. The platform provides a full suite of Clinical Trial Automation capabilities, including eCOA, eConsent, ePRO, EDC, MDR, SCE, Data Warehouse, and Workflow automation. These can either replace existing Clinical Trial Management Systems (CTMS) or be integrated on a module-by-module basis.


  **Average Rating:** 4.5/5.0
  **Total Reviews:** 2

**User Satisfaction Scores:**

- **Ease of Use:** 10.0/10 (Category avg: 8.9/10)
- **Quality of Support:** 7.5/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Trialize AG](https://www.g2.com/sellers/trialize-ag)
- **Year Founded:** 2020
- **HQ Location:** Zug, CH
- **LinkedIn® Page:** http://linkedin.com/company/trialize (6 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Company Size:** 100% Enterprise


#### Pros & Cons

**Pros:**

- Ease of Use (1 reviews)
- Efficiency (1 reviews)
- Time-saving (1 reviews)


  ### 13. [Agatha Clinical eTMF](https://www.g2.com/products/agatha-clinical-etmf/reviews)
  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 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. Benefits - Inspection Ready Your Trial Master File is up-to-date at all times and ready for sponsors, CROs, sites, and most importantly, auditors and inspectors. - Fully Automated & Efficient Document creation, review, and approvals are fully automated to ensure efficient and effective execution of all trial activities. - Connected to Everyone Every authorized trial participant — sponsors, CROs, and sites — can connect to the eTMF without the need for cumbersome IT processes. Fully Compliant - Agatha Clinical is built around the industry-standard eTMF reference model and ensures that every document expected in the file is present. Features - Create and Manage Sites & Documents - Create and manage trial sites based on the TMF Framework. Combine documents and forms to accelerate study processes. - Access Workspaces and Tasks in the Dashboard - View all your workspaces for each clinical trial site in the dashboard and quickly see and access tasks assigned to you. Use the configurable views to inspect, verify, and identify gaps in the expected eTMF contract at any time. Agatha Clinical (eTMF) Advanced Forms - Work with ready-to-use standard forms and processes, or adapt them to support your needs. Forms include rich text fields that allow the addition of images and formatted text. Use the form designer to update the look and feel of your forms. - A single multi-part form supports all steps in a process. Reviews, approvals, and assignments for actions are also built-in. - Author and Edit Documents Directly in the App - Co-Author and edit Microsoft Word, Excel, and PowerPoint files directly in the application, without the need for a Microsoft Office license. Annotate PDF, Office documents, and images with a simultaneous review of documents. - Ensure Quality Checks Are Completed - Designate documents for the quality check process and track the quality review using custom views. Complete Metrics and Reporting - Get all the reporting you need with built-in dashboards and reports, and export reports for external reporting requirements. You can also create views and reports across workspaces and export results to Excel for dashboard reports. Plus: - Extended Template Sets - Collect feedback from sites with Post Market Surveys and collect consent documents with Informed Consent. - Advanced Policy And Access Management - Manage policies, associated roles, and access controls easily. - Advanced Integration Toolkit - Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code). Secure Cloud Agatha Applications are cloud-based, hosted in Agatha’s highly secure, highly reliant, high-performance, compliant, cloud environment. Three Editions: Standard, Extended, and Premium Some features are only available in Extended or Premium editions.


  **Average Rating:** 3.5/5.0
  **Total Reviews:** 1

**User Satisfaction Scores:**

- **Ease of Use:** 8.3/10 (Category avg: 8.9/10)
- **Quality of Support:** 0.0/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Agatha](https://www.g2.com/sellers/agatha)
- **LinkedIn® Page:** http://www.linkedin.com/company/agatha-bijoux (5 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Company Size:** 100% Enterprise


  ### 14. [Florence eTMF](https://www.g2.com/products/florence-etmf/reviews)
  Florence software connects home health care data from outside the clinic with the healthcare community.


  **Average Rating:** 5.0/5.0
  **Total Reviews:** 1


**Seller Details:**

- **Seller:** [Florence Healthcare](https://www.g2.com/sellers/florence-healthcare)
- **Year Founded:** 2014
- **HQ Location:** Atlanta, Georgia
- **Twitter:** @FlorenceHCare (910 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/florence-healthcare/ (336 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Company Size:** 100% Small-Business


  ### 15. [Aurea Compliance Manager](https://www.g2.com/products/aurea-compliance-manager/reviews)
  Aurea Compliance Manager delivers end-to-end integrated solutions designed to address the specific workflow and compliance needs in the Life Sciences.




**Seller Details:**

- **Seller:** [Aurea Software](https://www.g2.com/sellers/aurea-software)
- **Year Founded:** 2012
- **HQ Location:** Austin, TX
- **Twitter:** @AureaSoftware (483 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/2923561/ (225 employees on LinkedIn®)



  ### 16. [Chronicles CTMS](https://www.g2.com/products/chronicles-ctms/reviews)
  Full cycle product for R&D teams in Pharmaceutical Industry. The product includes Electronic Trial Master File, Trial Management, Electronic Document Management with eSignature support. That is suitable for regulated areas as it is fully compliant with 21CFR Part 11 requirements.




**Seller Details:**

- **Seller:** [Chronicles Research Team](https://www.g2.com/sellers/chronicles-research-team)
- **Year Founded:** 2021
- **HQ Location:** N/A
- **LinkedIn® Page:** https://www.linkedin.com/company/chronicles-research-team/ (3 employees on LinkedIn®)



  ### 17. [CleanWEB](https://www.g2.com/products/cleanweb/reviews)
  A global solution for the electronic management of clinical trials EDC – IWRS – CTMS – CDMS – ePRO – IoTs – eTMF … CleanWEB is a secure Internet platform dedicated to managing national or international clinical electronic studies, registries and cohorts, mono or multi-centric. It is especially made for projects of all kinds: clinical trial from phase I to IV, real-life based studies, veterinary studies, epidemiological studies. Certifications : CDISC ODM – ISO 9001:2008 – 21 CFR Part 11 Compliance




**Seller Details:**

- **Seller:** [Telemedicine Technologies](https://www.g2.com/sellers/telemedicine-technologies)
- **Year Founded:** 2000
- **HQ Location:** Boulogne Billancourt, FR
- **LinkedIn® Page:** https://www.linkedin.com/company/telemedicine-technologies (39 employees on LinkedIn®)



  ### 18. [Clindex](https://www.g2.com/products/clindex/reviews)
  A Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC) all in one powerful, integrated solution.


  **Average Rating:** 4.2/5.0
  **Total Reviews:** 3

**User Satisfaction Scores:**

- **Ease of Use:** 8.3/10 (Category avg: 8.9/10)


**Seller Details:**

- **Seller:** [Fortress Medical Systems](https://www.g2.com/sellers/fortress-medical-systems)
- **Year Founded:** 1997
- **HQ Location:** Hopkins, US
- **Twitter:** @plista (1,393 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/3134457?trk=tyah&trkInfo=tas%3AFORTRESS%20MEDICAL%2Cidx%3A1-2-2 (8 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Company Size:** 67% Mid-Market, 33% Enterprise


  ### 19. [Clinevo eTMF](https://www.g2.com/products/clinevo-etmf/reviews)
  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. We are committed towards delivering the most efficient and practical end-to-end solutions with HIPAA, GXP, CSV, 21 CFR Part 11 and other applicable regulatory guidelines. Our unmatched domain experience and technology expertise enable us to deliver the best solutions.




**Seller Details:**

- **Seller:** [Clinevo Technologies](https://www.g2.com/sellers/clinevo-technologies)
- **Year Founded:** 2016
- **HQ Location:** Bangalore, IN
- **LinkedIn® Page:** https://www.linkedin.com/company/13426084 (98 employees on LinkedIn®)



  ### 20. [ClinicalHawk eTMF](https://www.g2.com/products/clinicalhawk-etmf/reviews)
  Our electronic Trial Master File (eTMF) simplifies today’s over-engineered products and implementations by empowering oversight without busting the budget. ClinicalHawk eTMF software is one of its kind for managing documents in real-time as the TMF is generated to ensure a constant state of inspection readiness, increase visibility oversight, and improve collaboration.




**Seller Details:**

- **Seller:** [N2NAcers](https://www.g2.com/sellers/n2nacers)
- **Year Founded:** 2021
- **HQ Location:** Ahmedabad, IN
- **LinkedIn® Page:** https://www.linkedin.com/company/clinicalhawk (2 employees on LinkedIn®)



  ### 21. [Clinion](https://www.g2.com/products/clinion/reviews)
  Clinion’s award-winning eClinical platform offers a unified suite of solutions—including EDC, RTSM, CTMS, eCOA, and Document Automation—designed to streamline and accelerate every aspect of clinical trials. Recognized for its innovation, Clinion leads the industry with one of the most integrated and intelligent platforms available. Clinion enables users to effortlessly manage the complexities of clinical trials by sharing consistent trial data across the entire trial process leading to accelerated clinical development, increased compliance, and faster go-to-market. Key Differentiator: ● Accelerated Start: Clinion has one of the fastest study setup times (from protocol to production) in the industry. ● Ease of Use: Clinion is very intuitive and easy to use, with only minimal training required. ● High-quality data and fast study management: Clinion uses AI and automation for improved data quality, enabling customers to close studies faster. ● Budget-friendly pricing: Clinion comes with flat monthly subscription fees with no hidden costs.


  **Average Rating:** 4.5/5.0
  **Total Reviews:** 2

**User Satisfaction Scores:**

- **Ease of Use:** 9.2/10 (Category avg: 8.9/10)
- **Quality of Support:** 10.0/10 (Category avg: 8.3/10)


**Seller Details:**

- **Seller:** [Clinion](https://www.g2.com/sellers/clinion-e18ccd88-cb44-4bcb-a5cf-8a814664dc7a)
- **Year Founded:** 2010
- **HQ Location:** Austin, US
- **Twitter:** @clinion (53 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/clinion-eclinical-platform/?viewAsMember=true (73 employees on LinkedIn®)

**Reviewer Demographics:**
  - **Company Size:** 100% Small-Business


  ### 22. [ClinVigilant eClinical](https://www.g2.com/products/clinvigilant-eclinical/reviews)
  Streamline your clinical studies with ClinVigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The ClinVigilant® eClinical suite includes: EDC, eCRF, CTMS, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. How simple and user-friendly is it? Ask for a demo to find out! Clinvigilant💊, your one-stop 🌐solutions provider for ☁️clinical trials . Enquiries \> bd@clinvigilant.com




**Seller Details:**

- **Seller:** [ClinVigilant](https://www.g2.com/sellers/clinvigilant)
- **Year Founded:** 2017
- **HQ Location:** Dartford, GB
- **LinkedIn® Page:** https://www.linkedin.com/company/clinvigilantresearch (19 employees on LinkedIn®)



  ### 23. [Cloudbyz eTMF](https://www.g2.com/products/cloudbyz-etmf/reviews)
  Cloudbyz eTMF solution offers a cloud-based repository of all clinical trial documents including files, images, information, etc. Digitally store, manage, and share 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.




**Seller Details:**

- **Seller:** [Cloudbyz](https://www.g2.com/sellers/cloudbyz)
- **Year Founded:** 2014
- **HQ Location:** Naperville, US
- **Twitter:** @cloudbyz (402 Twitter followers)
- **LinkedIn® Page:** https://www.linkedin.com/company/cloudbyz (100 employees on LinkedIn®)



  ### 24. [ComplyDocs eTMF](https://www.g2.com/products/complydocs-etmf/reviews)
  ComplyDocs eTMF is an electronic Trial Master File (eTMF solution designed to digitize and streamline the management of essential clinical trial documents. By transitioning from traditional paper-based systems to a digital platform, ComplyDocs eTMF enhances the efficiency, accessibility, and compliance of clinical trial documentation processes. Key Features and Functionality: - Digital Document Management: Enables the electronic capture, organization, and storage of all essential clinical trial documents, ensuring centralized access and improved document control. - Regulatory Compliance: Supports adherence to regulatory requirements by maintaining comprehensive audit trails, version control, and secure access, aligning with standards such as FDA 21 CFR Part 11. - Collaboration Tools: Facilitates seamless collaboration among clinical trial stakeholders through user-friendly interfaces and robust functionalities, allowing for efficient document sharing and communication. - Automated Workflows: Streamlines processes with automated workflows for document review, approval, and archiving, reducing manual tasks and minimizing errors. - Real-Time Monitoring: Provides real-time tracking and reporting capabilities, offering insights into document status and trial progress to ensure timely decision-making. Primary Value and User Solutions: ComplyDocs eTMF addresses the challenges associated with managing vast amounts of clinical trial documentation by offering a centralized, digital solution that enhances efficiency and compliance. It reduces the reliance on paper-based systems, minimizes the risk of document mismanagement, and ensures that all trial documents are audit-ready and easily accessible. By automating workflows and facilitating collaboration, ComplyDocs eTMF helps organizations accelerate trial timelines, maintain regulatory compliance, and improve overall trial management.




**Seller Details:**

- **Seller:** [ComplyDocs](https://www.g2.com/sellers/complydocs)
- **HQ Location:** N/A
- **LinkedIn® Page:** https://www.linkedin.com/company/No-Linkedin-Presence-Added-Intentionally-By-DataOps (1 employees on LinkedIn®)



  ### 25. [ConciergeTMF](https://www.g2.com/products/conciergetmf/reviews)
  ConciergeTMF is an innovative Software-as-a-Service (SaaS) provider specializing in Research and Development (R&D) archival management. Their unique approach transcends traditional software solutions by offering a comprehensive platform that seamlessly blends technology and human expertise. Key features of ConciergeTMF's platform include: Human-in-the-Loop Intelligence: At the core of ConciergeTMF's offering is the fusion of AI technology with human oversight. This synergy ensures that document management is not only efficient but also exceptionally precise, reliable, and trustworthy. Dynamic Event Center: The platform boasts a Dynamic Event Center that provides real-time visibility into document progress. It facilitates storyboarding and offers gamified project management tools, empowering users with a holistic view of their document journeys. Multi-Channel and Passive Access Communications: ConciergeTMF simplifies communication by offering a unified platform for email, text routing, and task location placeholders. This feature promotes effortless collaboration and coordination among team members, enhancing productivity. Streamlined Processes: With ConciergeTMF, users bid farewell to repetitive tasks such as uploading and redundant user administration. The platform streamlines document workflows and eliminates access management hassles, allowing teams to focus on high-impact activities. End-to-End TMF Platform: ConciergeTMF's platform is designed to facilitate end-to-end document retention. It ensures agility in a dynamic research landscape, providing the flexibility and compliance needed in the field. ConciergeTMF's commitment to excellence is evident in their comprehensive approach to R&D archival management. By seamlessly integrating technology with human intelligence, they empower organizations to achieve unmatched precision, efficiency, and compliance in their document management processes. Experience the transformative power of ConciergeTMF's SaaS platform and unlock the full potential of your R&D archival management.




**Seller Details:**

- **Seller:** [ConciergeTMF](https://www.g2.com/sellers/conciergetmf)
- **HQ Location:** N/A
- **LinkedIn® Page:** https://www.linkedin.com/company/No-Linkedin-Presence-Added-Intentionally-By-DataOps (1 employees on LinkedIn®)





## Parent Category

[Clinical Research Software](https://www.g2.com/categories/clinical-research)