Top Solutions for eTMF Clinical Trials

What is an electronic trial master file (eTMF) in clinical trials?

A trial master file (TMF) is a collection of essential documents that includes all records related to a clinical trial. Such documents are required for regulatory submissions, audits, and inspections. An electronic trial master file (eTMF) is a digital version of the TMF that is stored and managed electronically.[¹]

The eTMF is designed to replace the traditional paper-based TMF, which can be cumbersome and difficult to manage. The eTMF allows for faster access to information and streamlined collaboration among study teams. It is also considered more secure and easier to update and maintain.

The eTMF supports easier storage, organization, and retrieval of essential documents and facilitates real-time review of data and documents by stakeholders involved in the study.

eTMFs have become increasingly popular in recent years as more and more clinical trials have moved away from paper-based processes and towards electronic systems. eTMFs offer several advantages over traditional paper-based systems, including increased efficiency, improved collaboration and information sharing, better data accuracy and integrity, and also significantly assists with the auditing process and demonstrating regulatory compliance.

Trial master file (TMF) essential documents

The eTMF contains all the documents required to support a clinical trial's conduct, monitoring, and management.[²] These documents may vary slightly depending on the specific study and regulatory requirements, but typically include the following:

1. Study protocol: This document outlines the objectives, design, methodology, and procedures for the clinical trial.
2. Investigator's brochure: This comprehensive document provides information about the investigational product being tested in the clinical trial.
3. Informed consent forms (ICFs): These documents provide information to potential study participants about the trial, including risks and benefits, so they can make an informed decision about whether or not to participate. They are also used to formalize the participants’ consent.
4. Case report forms (CRFs): These forms are used to collect all patient-related data during the study, including study participants’ personal information, treatment assignments, and outcomes.
5. Clinical study reports (CSRs): These reports summarize the clinical trial results, including statistical analyses and conclusions.
6. Regulatory documents: These include documents such as Investigational New Drug (IND) applications, Institutional Review Board (IRB) approvals, and other regulatory filings with the FDA or other applicable regulatory bodies.
7. Monitoring and auditing reports: These documents summarize the activities of the study monitors and auditors, including any findings or issues identified during the trial.
8. Correspondence: This includes any correspondence related to the study, including letters and emails between study staff, sponsors, and regulatory agencies.
9. Training records: These documents detail the training provided to study staff, including documentation of training completion and competency assessments.
10. Safety information: These documents include adverse event reports, serious adverse event reports, and other safety-related information.

What are the advantages of an eTMF?

There are several reasons why sponsors and contract research organizations (CROs) are recommended to use electronic trial master files (eTMFs) in clinical trials[³]:

• Improved efficiency: eTMFs allow for easier and faster sharing, review, and tracking of study documents, enabling more efficient communication among stakeholders and faster decision-making.
• Enhanced collaboration: eTMFs enable all study team members to access the same documents from any location, facilitating collaboration and ensuring consistency across the study.
• Increased compliance: eTMFs help ensure that all documents are up-to-date, complete, and in compliance with regulatory requirements, making it easier to meet audit and inspection requirements.
• Greater data security: eTMFs offer improved data security, including access controls, data encryption, and backups, reducing the risk of loss or theft of confidential information.
• Real-time monitoring: eTMFs enable real-time monitoring of study progress, allowing for early identification of issues and enabling investigators/monitors to take corrective action more quickly.
• Cost savings: eTMFs can help reduce the costs associated with document storage, printing, and distribution, as well as costs resulting from errors or inconsistencies in data entry.

Top 13 eTMF vendors

There are a variety of eTMF vendors on the market, offering different features and capabilities to meet the needs of various stakeholders in the clinical research industry. Below are the top 13 eTMF vendors that offer the best features for clinical trial managers and sponsors (listed in no particular order).

Trial Interactive eTMF

Trial Interactive is an electronic trial master file solution that offers a range of features that make it stand out, including its ease of use, flexibility, and customizability.

Trial Interactive eTMF offers advanced document tracking capabilities, allowing users to easily monitor the progress of their documents and quickly identify any gaps or missing items. The platform includes features such as version control, electronic signatures, and audit trails, which help ensure compliance with regulatory requirements and industry standards.

Another standout feature of Trial Interactive eTMF is its integration capabilities. The platform can seamlessly integrate with other clinical trial systems and tools, such as electronic data capture (EDC) and clinical trial management systems (CTMS), allowing for easy data exchange and streamlined workflows[⁴].

May be ideal for: Sponsors and CROs looking for an intuitive and flexible eTMF solution that is easily tailored to specific needs.

Medidata Rave eTMF

Medidata Rave eTMF offers a comprehensive range of features that enable sponsors and CROs to efficiently collect, manage, and archive all trial documents in compliance with regulatory requirements.

One of the unique features of Medidata Rave eTMF is its ability to integrate with other Medidata products, such as Medidata Rave EDC (electronic data capture) system. This integration enables seamless data transfer between the two systems, allowing for a more efficient workflow and reducing the need for manual data entry. In addition, Medidata Rave eTMF offers advanced security features such as access controls, data encryption, and backups to ensure that all trial data is protected from unauthorized access or loss.[⁵]

May be ideal for: Sponsors and CROs looking for an eTMF solution that is easy to use, scalable, and adaptable to different study designs.

Aurea Compliance Manager

Aurea Compliance Manager is a comprehensive solution designed to help life sciences companies manage their regulatory compliance obligations efficiently. Aurea Compliance Manager provides a unified view of compliance across multiple functions and geographical locations, enabling companies to manage their regulatory compliance obligations in a coordinated and effective manner. It also offers powerful analytics capabilities, enabling users to track and monitor compliance performance, identify potential compliance risks, and take proactive steps to mitigate them.

May be ideal for: Sponsors and CROs who need a comprehensive compliance management solution with powerful built-in analytics and risk management functions.

Phlexglobal’s PhlexTMF

Phlexglobal's PhlexTMF is an eTMF solution equipped with a powerful document workflow engine that automates document review and approval processes, ensuring that all documents are processed promptly and efficiently. The solution also provides real-time visibility into the status of each document, allowing stakeholders to monitor progress and identify potential bottlenecks[⁶].

PhlexTMF is also unique in its ability to integrate with a wide range of other clinical trial software solutions. The solution is designed to work seamlessly with popular EDC and CTMS platforms as well as various other tools commonly used in clinical research. These integration capabilities allow users to streamline their workflows, reducing the time and effort required to manage clinical trial documentation.

May be ideal for: The solution is particularly well-suited for organizations managing complex, multi-site clinical trials, where the efficient and timely management of clinical trial documents is critical to the study's success.

SureClinical SureETMF

SureClinical SureETMF offers a range of features including document tracking, version control, and collaboration tools, and uses blockchain technology to provide an added layer of security and transparency to the platform. This means that all documents stored on the platform are tamper-proof and can be traced back to their source, ensuring that the integrity of the data is maintained throughout the trial. SureETMF™ integrates readily with other electronic tools such as EDC and clinical trial management systems (CTMS), allowing for seamless data transfer and document management across multiple platforms, and is compliant with regulatory frameworks in various countries.

May be ideal for: Sponsors looking for a highly secure eTMF platform that offers multilingual support and compliance with regulatory requirements in multiple countries.

IQVIA eTMF

IQVIA eTMF is eTMF software that is part of the IQVIA Digital Site Suite and is designed to integrate with other IQVIA technologies and solutions such as their Data Management and Clinical Monitoring services, providing sponsors with a seamless end-to-end solution for their clinical trial needs, ensuring that data flows efficiently and securely throughout all clinical trial operations.

IQVIA eTMF also offers document tracking, version control, and collaboration tools, enabling sponsors to manage their documents efficiently and ensuring that all stakeholders are informed and up-to-date with the latest information. The platform also includes robust audit and inspection support, helping sponsors prepare for audits and inspections quickly and efficiently[⁷].

May be ideal for: Sponsors who require a flexible and scalable solution to manage complex, multi-site clinical trials with large amounts of documentation.

Veeva Vault eTMF

Veeva Vault eTMF offers a range of features, including document tracking, version control, and collaboration tools, and is designed to directly support compliance with regulatory requirements. It easily integrates with other Veeva products, including Veeva Vault CTMS and Veeva Vault Study Startup. The platform offers customizable dashboards, allowing users to view key metrics and performance indicators in real time and set up automated notifications and alerts to stay on top of important tasks[⁸].

May be ideal for: Sponsors looking for a comprehensive eTMF solution that integrates seamlessly with other clinical trial management systems by the same provider. The platform is particularly well-suited for organizations looking to streamline their document management processes, improve collaboration and communication across study teams, and meet the needs of regulatory bodies.

Montrium eTMF Connect

Montrium's eTMF Connect offers a range of features that make it stand out, including advanced analytics and reporting tools. The platform offers real-time data visualization and reporting capabilities, allowing sponsors and CROs to quickly and easily track the progress of their clinical trials[⁹]. The platform also offers a secure and compliant solution for electronic signatures, ensuring that all signatures are valid and meet regulatory requirements. This feature simplifies the signature process and reduces the need for manual paper-based signatures.

May be ideal for: Sponsors looking for advanced analytics and reporting tools, electronic signature capabilities, and a user-friendly interface.

Florence eTMF

Florence eTMF offers advanced features such as automatic document routing, version control, and real-time document completion and status monitoring, which can help sponsors save time and increase efficiency. Florence eTMF also maintains a comprehensive audit trail, which can help sponsors demonstrate compliance with regulatory requirements. The platform includes built-in quality control checks and automated notifications, which can help to reduce the risk of errors and ensure that all documentation is up-to-date and complete. A unique feature of Florence eTMF is its customizable workflows and templates, which users can tailor to their specific needs, allowing them to streamline their document management processes and improve collaboration among team members [¹⁰].

May be ideal for: Florence eTMF is an ideal solution for sponsors and CROs looking for a user-friendly, customizable, and compliant eTMF platform.

MasterControl eTMF Manager

MasterControl eTMF Manager provides a fully integrated solution that combines document management, quality management, and regulatory compliance into a single platform. This integration allows for seamless stakeholder collaboration, enhanced quality control, and streamlined compliance with regulatory requirements. MasterControl eTMF Manager™ can automate document tracking and version control, reducing the risk of errors and ensuring that all documents are up-to-date and in compliance with regulatory requirements.

May be ideal for: Sponsors and CROs looking for a comprehensive, user-friendly, and customizable eTMF solution suitable for use in a wide range of clinical trials.

Egnyte eTMF

Egnyte eTMF integrates easily with other clinical trial management systems, including EDC and CTMS. Moreover, Egnyte eTMF also offers a mobile application which provides secure access to trial documents, allowing users to review, annotate, and collaborate on documents, even when not in the office, making it an ideal solution for remote teams. Another unique feature of Egnyte eTMF is its advanced security, which includes 256-bit AES encryption, two-factor authentication, and data residency options, ensuring that trial data is secure and compliant with regulatory requirements.

May be ideal for: Sponsors who require a flexible, secure, and scalable eTMF platform. It is particularly suitable for sponsors with remote teams due to the secure document access from its mobile app.

SimpleTrials

SimpleTrials is an eTMF platform designed to provide an intuitive and user-friendly interface and offers a range of features to support the efficient and secure management of study documents, including document tracking, version control, and collaboration tools. SimpleTrials also offers a range of features to support compliance with regulatory requirements, including automated workflows, document security controls, and audit trails. The platform is fully customizable, allowing sponsors and CROs to tailor the system to their needs and workflows. A unique aspect of SimpleTrials is its focus on customer support. The company offers personalized onboarding, training, and support services to ensure that users can fully leverage the platform's capabilities. Interestingly, SimpleTrials offers flexible pricing options based on each customer's specific needs, which can be ideal for smaller sponsors or CROs with limited budgets.

May be ideal for: SimpleTrials’ focus on customer support and flexible pricing options make it attractive for small to mid-sized organizations managing multiple or complex trials and looking for a very user-friendly product.

Cloudbyz eTMF

Cloudbyz eTMF provides a secure and centralized location for storing all clinical trial documentation, enabling easy sharing, reviewing, and tracking of documents among stakeholders. The platform can be easily integrated with CTMS, EDC, and electronic health record (EHR) systems, enabling seamless data transfer and reducing the risk of data duplication or errors. Cloudbyz eTMF offers a cost-effective solution that can help reduce the time and resources required for managing clinical trial documents. The platform provides a range of features designed to meet the regulatory requirements of different regions, including FDA 21 CFR Part 11 compliance, and can be customized to meet the specific needs of individual studies.

May be ideal for: Sponsors who require an eTMF that integrates easily with other clinical trial management systems and a user-friendly interface for efficient document management and enhanced regulatory compliance.

Questions to ask when choosing an eTMF vendor

When selecting an electronic trial master file (eTMF) vendor, it is important to ask the right questions to ensure that the vendor meets your organization’s or trial’s specific needs and requirements. Here are some questions to ask the eTMF vendor, or to at least keep in mind when reviewing their offering:

1. What regulatory standards and guidelines does the eTMF system comply with?

The eTMF vendor should comply with the relevant regulatory standards and guidelines, such as FDA 21 CFR Part 11, ICH E6(R2), GDPR, and HIPAA[¹¹],[¹²],[¹³],[¹⁴].

2. How secure is the eTMF system?

The software should include robust security measures to protect the confidentiality and integrity of clinical trial data. Ask about the vendor's security protocols, encryption methods, backup procedures, and disaster recovery plan.

3. What features does the eTMF system offer?

Ask about the system's features, such as document versioning, electronic signatures, audit trails, search and filter capabilities, and reporting. Also, inquire about the capacity for the system to integrate with other clinical trial management tools and electronic data capture (EDC) systems in order to further streamline trial and data management.

4. How user-friendly is the eTMF system?

Ask about the user interface, navigation, and ease-of-use of the eTMF system. Better yet, try it out – many providers offer free demos of their product so you can get a feel for what it will be like to work with it. Inquire about the system's customization options, such as the ability to add or modify document types, templates, and workflows.

5. What kind of customer support does the eTMF vendor provide?

Ask about the vendor's customer support services, which might include training, technical support, and help with setup or customization. Inquire about the vendor's response time for addressing issues and their availability during business hours, especially if you foresee high risk or potentially urgent issues with any processes related to the eTMF in your study.

6. What pricing options does the eTMF vendor offer?

Ask about the pricing models and packages the vendor offers, including both upfront costs and subscription fees. Check whether there are additional fees for customization, integration, or support services, or if any side features you don’t need can be excluded in order to lower the price.

7. Can the eTMF system accommodate my study size and complexity?

Ask about the scalability and flexibility of the eTMF system, including its ability to accommodate trials of different size and complexity. Also, inquire about the vendor's experience supporting similar studies (either trials of the same phase or in a similar clinical field), and their success rate.

Conclusion

When choosing an eTMF vendor, it is essential to consider regulatory compliance, data security, user-friendliness, integration capabilities, customizability and scalability, customer support, and pricing. By considering these factors, sponsors and CROs can select an eTMF vendor that meets the specific needs of their trial and/or organization. A well-matched solution will be of great help to sponsors and CROs in managing clinical trial documentation more efficiently and improving regulatory compliance.