Managing your Trial Master File (TMF) is a necessary, and often tedious task for most clinical stakeholders—but it doesn’t have to be. When teams rely on legacy systems using outdated file sharing technology or homegrown systems leveraging spreadsheets or paper, they open themselves up to vulnerabilities in managing sensitive trial data and essential documents. Over the last decade, electronic Trial Master File (eTMF) systems have helped many biopharmas and CROs manage the growing complexity of clinical trial document management. But not all eTMF systems possess the agility and functionality needed to support modern trial operations.
How can sponsors, CROs, and other key stakeholders determine when there is a business case for an eTMF? Once decided, how can they evaluate which system is right for them? Knowing what questions to ask helps to ensure the eTMF system that you select is both comprehensive and compliant. We will tackle the key questions you need to answer when evaluating an eTMF system and vendor.
What is an eTMF System?
In its simplest form, eTMF systems offer an electronic method for the collection and management of essential trial documents that are part of the TMF record.
eTMF systems are more than a shift from paper-processes to electronic alternatives. They facilitate the management of the TMF and ensure evaluation of clinical trial conduct, integrity of trial data, and compliance with Good Clinical Practices (GCP). The right eTMF system should offer functionality that enables real-time management of essential documents, centralizes your data for easy cross-functional collaboration, and makes sure your TMF is regulatory ready.
What is driving adoption of eTMF systems?
Clinical teams are experiencing unmanageable complexity — decentralization, globalization, growing data sources, and dispersed teams — additional pressures that compound with traditional struggles like increasing ROI. These challenges result in timeline delays, siloed teams, and threats to data integrity and patient safety.
eTMF systems enable organizations to manage TMF complexity with automated workflows, real-time access to essential documents, collaborative dashboards, and built-in compliance to reduce the risk of audit findings. The shift from paper to digital is fueling positive change in the industry as more organizations experience an optimization of their internal processes.
Who benefits from an eTMF system?
Managing essential documents manually or through homegrown solutions can work for a time; but as trials collect data from additional endpoints or study volume increases, manual efforts become more challenging and costly. A modern eTMF system enables organizations to automate their document management and conduct remote workflows using pre-configured templates, dashboards, and audit trails that automatically protect data integrity and keep you regulatory ready.
As studies change and grow over time, the eTMF is responsive and scales alongside you in a way that legacy or homegrown systems cannot match. Therefore, organizations will benefit greatest from switching to an electronic TMF system if:
- They are experiencing an expanding clinical trial pipeline.
- They are increasing the number of studies or the size of their studies in the near future.
- They are planning for an upcoming audit or inspection.
- They are expecting growth and want to proactively plan for it.
What are the steps to create a business case for an eTMF system?
To determine if your organization would benefit from a modern eTMF, start by evaluating your internal people, processes, and existing systems:
- Calculate the costs of your current TMF document handling and storage.
- Determine how much time you spend on TMF planning prior to study start-up.
- Evaluate your inspection readiness (i.e., the amount of time for TMF audits and inspections).
- Set operational efficiency goals for TMF (i.e., time for implementation, time to value, etc.).
Mapping out existing TMF processes is a tedious, but hugely beneficial step in establishing the business case for a modern eTMF system. Once completed, you are ready to begin the RFP process where the eTMF vendor can map your processes to their system and give you a realistic understanding of your timelines and total cost of ownership.
Who should evaluate the eTMF?
Many trial stakeholders interact with the TMF throughout the course of a study including sponsors, investigators, CROs, and more. Therefore, evaluating an eTMF system should not be a single-person task. Depending on the size of your organization, it may benefit you to involve individuals from these teams:
- Clinical Operations — reviews the operational efficiency of the eTMF
- IT — evaluates system integrations and reviews vendor Service Level Agreements (SLAs)
- Data Management — ensures data is safely uploaded, stored, and managed within the eTMF
- Quality — ensures data integrity is maintained throughout the trial
- Finance —reviews pricing and contracts; determines ROI and total cost of ownership for the system
- CRO (if applicable) — discuss requirements for managing the eTMF
Each stakeholder should evaluate the system and consider how the eTMF will impact existing people, processes, and systems within their function. During this evaluation, consider how much training is needed to onboard each team to the eTMF system.
What are critical eTMF capabilities to consider?
- Ease of Use
eTMF systems are meant to simplify trial document management, which is why an intuitive, configurable user experience is key. Clean UI/UX lends itself to more limited training by enabling teams to navigate the system autonomously.
- Built-In Compliance
A modern eTMF system will have built-in workflows and quality controls to maintain compliance and mitigate findings in the TMF. It will also provide current TMF reference model capabilities out-of-the-box.
- Security Measures with Adjustable Permissions
Role-based functionality and permission management settings help protect the sensitive nature of trial data and should be included in a modern eTMF system. Your system would also benefit from having a TMF Viewer that provides read-only files for auditors.
- In-App Document Review and Workflows
Real-time TMF view functions help clinical teams stay inspection-ready, while flexible dashboards empower teams to work collaboratively and track the status of documents and metadata.
- Report Generation and Distribution
Ensure your eTMF has flexible reporting that lets you automatically generate reports to track completion of TMF documents, track follow-up, and make data-driven decisions.
There are a diverse range of automation capabilities offered through eTMF systems. To determine the right balance of automation and functionality needed to manage your TMF, complete this comprehensive checklist.
What are common pitfalls to watch out for?
Not all eTMF systems are created equal. Avoid systems with rigid TMF structure because they may lack the ability to customize beyond the TMF reference model. eTMF systems should be able to integrate with other eClinical technologies such as a CTMS or EDC to create a single source for trial data. Be wary of eTMF systems that lack integrations or offer limited integration capabilities that prevent real-time, accurate access to your data.
How to determine the right vendor or partner for you?
eTMF providers are an extension of your team; which is why it is critical to find a provider that offers the right balance of functionality, training, and ongoing support for your needs. Are you looking for a partner who offers comprehensive training, dedicated account resources, and a collaborative process? Or do you need a more autonomous approach?
Whether you are making the leap from paper processes, upgrading from a homegrown solution, or migrating from another system—the vendor you select will be paramount in aiding you in the process. Learn more about the considerations you should make when evaluating and eTMF system and vendor. Watch our recent webinar, 10 Questions When Selecting an eTMF System.