Over the next few paragraphs, I will provide guidance on how to choose the right eTMF for your organization based on my almost 10 years of consulting on eTMF. I helped dozens of organizations improve their trial master file (TMF) management capabilities during my time consulting for life sciences organizations. While each of these organizations was different, they all had the same goal – to improve inspection readiness. Sometimes the engagement was process- and operating model-focused, but oftentimes it centered around the selection and implementation of a new electronic trial master file system. Over the next few sections, I will share some of the best practices for selecting the best eTMF for your organization.
Have a clear picture of your future state
Too often, I saw organizations begin the process of selecting an eTMF without understanding how they were going to use the system. I always urged clients to hit pause on the evaluation and ensure that the team knew the operating model and processes that the tool would have to support. While many of the top eTMF solutions have flexibility, some have been designed with assumptions around the operating model that they will support.
Operating Model Impacts
Every life sciences organization is slightly different regarding how they are structured and how they perform work. Some organizations prefer a decentralized model where every study team member is responsible for processing their own content, while others prefer a model where content is handed off to a central team that is responsible for all of the processing. While both of these models involve users processing content, their different approaches can have implications on security and licensing/costs, so you need to ensure you consider this.
In addition to internal operating models, the dynamic with CROs can play a big role in what you expect your eTMF to support. In some organizations, the preference is to outsource as much study execution to CRO partners, while others desire to have as much of the activity performed internally. When the execution is outsourced to CROs, you need to define where the CRO will be doing the TMF management. Are they going to be using the Sponsor system during the trial, or will they use the CRO system and then transfer the content at the end of the study? Again, the top eTMF solutions should support both of these models, but you need to have some idea of the approach because this will impact the configuration and licensing of the tools.
After you have a grasp on your current/future-state operating model, you can get a little bit more granular and focus on the processes you will perform to drive inspection readiness. When I was doing consulting, I worked with clients on defining their processes in the following four buckets:
For each of the buckets you should have at least a high-level understanding of how you want to perform the processes so you can evaluate if the eTMF solution can satisfy your needs.
Planning the TMF
As part of planning the TMF, organizations tend to focus on the following processes:
- Creating the study and adding countries and sites
- Tweaking the standard structure/inventory of content for that study
- Defining content expectations for the study, countries, and sites
- Assigning team members to the study
Look for a system that reduces the burden on the study team by:
- Reducing manual data entry of country/site/personnel info via bulk upload tools or integrations with other systems
- Leveraging templates and/or re-use of the content structure and expectation definition tools
Once the study has been created in the eTMF, the next step (and the one that is repeated most often during the study) is processing content. It involves:
- Creating/collecting content
- Loading content into the system and assigning metadata to the document
- Routing content through a workflow to drive finalization
Look for a system that makes it easier to get content into the system and to a finalized state by:
- Providing multiple ways to load content (individual, bulk upload, integration) as well as support for document re-use across studies/sites
- Assisting the user in populating metadata
- Providing multiple workflow routes to support the business needs (direct-to-final, review, approval w/eSig, etc.)
Once content starts coming into the system, it becomes a shared responsibility to understand the progress towards inspection readiness. This traditionally involves the trio of measures:
Look for a system that makes it easier to evaluate each of those components while streamlining the steps to remediate any issues that reporting reveals:
- Standard dashboards and reports that compare defined content expectations vs content present in the system
- Standard dashboards and reports that reveal processing performance (do study team members process content in a timely manner and without a lot of re-work?)
- The ability for end-users to create their own reports to answer questions that they, or leadership, may have
Preparing for and Supporting Inspections
Obviously, the ultimate goal of managing a TMF well is to position yourself for a successful audit/inspection. In addition to the reporting/capabilities, I listed above, a system should support the following to help drive inspection readiness:
- The ability of a study team, or delegate, to review finalized content to evaluate the inspection readiness for that document and route that document for remediation if required
- Ability to document that reviews have been performed in accordance with the TMF plan
- Ability to ingest content from a CRO partner (or other external systems) if that content wasn’t managed within the Sponsor eTMF during the course of the study
- Ability to archive studies/documents in place to ensure proper custody
- The ability to provide restricted access for Inspectors allows compliance with regulatory expectations
Have a clear understanding of the future of the vendor and the partnership
When thinking about the eTMF vendors out there, you will likely notice a wide range of providers. Some are software companies that are focused on building life sciences-specific applications, some are technology/consulting firms that are augmenting their core capabilities, and some are services companies that have built a technology to support their services and are now selling it to the industry. Regardless of the origin of the technology you are evaluating, you want to make sure your future partner has the following attributes:
- A track record of delivering a high-quality eTMF solution (can they build good software?)
- A track record of implementing for clients in an efficient manner (can they implement the software?)
- Financial security (will they have resources to continue to build/support me?)
- Continued focus (will they continue to improve their existing application?)
In addition to the potential partner’s individual history and outlook, it is important to think about how the relationship with them will look like. To be successful as partners, the vendor must:
- Care about your usage and success with the software and have a team focused on customer success
- Be eager to collaborate and be engaged in governance
- Be willing to provide insight into the future direction of the product
- Be able to provide technical and system support
In the previous paragraphs, I outlined the things to focus on during vendor selection of your future eTMF. This approach has helped many of my clients evaluate and choose an eTMF that has served them well in driving inspection readiness. While each organization is different and the importance you assign to each of the components may vary, it is important to think about each of the topics to ensure you have a holistic understanding of the vendor and their solution.
If you have any questions please contact me and I will do my best to provide additional insights.