tmf services /
tmf management

Put TMF management on auto-pilot

Our team of experts is available to support your trial master file management operations, freeing up your calendar to focus on what matters most: your clinical trials. Trust the leading provider of TMF management services for scaling life science organizations.

Improve active TMF management with our support

Building and maintaining high-quality, inspection-ready trial master files is what we’re all about—in fact, it’s kind of the whole reason we’re here. Now, we want to bring our knowledge and experience to helping you with every aspect of TMF management, from study start-up to study closure.

Study owners, let's lighten your workload

TMF oversight services

Make sure you’re never in the dark when it comes to your trial master file health. We’ll keep our finger on the pulse of your clinical studies with monthly TMF oversight cross-checks. We'll regularly follow up with your study teams to flag TMF completeness issues, possible inspection findings, and any other potential issues with the trial master file. Focus on the critical parts of your clinical trial and leave the TMF management to the experts.

Automated indexing services

Need some help getting your docs in a row? We can lend a hand by providing daily automated indexing. But we’re not doing it alone—we’ll be assisted by Montrium’s game-changing A.I. Think of us as an extension of your team; much like your contract research organizations (CROs), our group of expert TMF'ers will work side-by-side with your team to ensure the trial master file is compiled in a timely manner, complying with good clinical practice (GCP).

TMF quality check services

Ensuring the quality of your TMF is one of our top priorities. We provide daily A.I.-powered quality checks and quality reviews to guarantee that your TMF is one we can all be proud to put our names on. Our TMF consultants will work tirelessly to ensure that your trial documentation is of the highest quality and contributing to inspection readiness.

Query management services

We can help you crush your completeness objectives. How? With daily query management, fuelled by our advanced A.I. We'll take care of managing any issues that arise with your essential documentation, ensuring that it meets the regulatory requirements. TMF management is a complex endeavor, especially with smaller teams. So why not let our experts take the wheel?

TMF reconciliation services

Imagine if you could have a team of seasoned TMF experts swoop in and take over the complex, time-consuming process of trial master file reconciliation. Oh wait, now you can. We'll work to highlight key gaps in TMF documentation to ensure you meet minimum essential document requirements, as well as the documentation required as part of the investigator site file (ISF) and what's defined in the TMF Reference Model.

Have a question for our team?

Take advantage
of bespoke TMF process

At Montrium, we deeply understand the unique challenges faced by scaling clinical teams and we know that a one-size-fits-all approach is out of the question.  

That’s why we offer expertly-crafted process optimization services designed with your specific strengths and operational constraints in mind. We'll work with your team to adjust existing processes or implement new ways of working, all carefully detailed in comprehensive procedural documentation. We take into account nuances in your clinical trials, business process, and team environment to ensure the processes we design are fit for purpose. 

Let's get you performing at your best

Meet your new eTMF system administrator 

It's not that we wrote the book on eTMF system administration-
it's that we built the system itself.

Our administration services are backed by an exceptional understanding of the fundamentals of eTMF systems. Whether it’s managing user permissions or configuring workflows, we’re happy to do the administrative legwork for you, giving you back valuable time to focus on getting your product to market. We partner with study owners to ensure the completion of daily rigorous TMF tasks, allowing your study team to benefit form active TMF management, while staying focused on your clinical trials.

User management support

Gone are the days of being bogged down by updating users, roles, and permissions. We’ll help you manage all of these on a daily or monthly basis, depending on your needs. If your study owners don't have the internal IT resources to support you, we're here to act in their absence.

Study configuration services

Clinical trials are complex. It can be difficult for a TMF study owner to understand the path to study success in your eTMF. We can help you configure and maintain your study in the way that works best for you. Ensure your study TMF is setup correctly from the onset, giving you peace of mind as your clinical trial progresses. This includes assistance with: 

  • TMF index development & maintenance
  • Ongoing document workflow configuration 
  • Study milestone management 
  • Clinical site and country administration 
  • TMF metrics management 

TMF template development

Templates are the building blocks of successful processes. We can help you give them the attention they deserve by sourcing, customizing, and verifying your templates. While clinical research is wide-reaching and stacked with nuances and variables, our group of experienced TMF consultants ensure the templates your study teams will use are not only aligned with regulatory requirements and guidelines (e.g ICH GCP E6), but also your unique clinical trial environment. 

Let's shrink your to-do list

Enjoy no-frustration TMF migration

Looking to modernize your document management system but hesitant about the migration process?
We get it, TMF migration is daunting—but it doesn't have to be.

We provide hassle-free TMF migration services that will help you move your studies to your new system with
ease. Our team of experts will work with you to create a strategy that minimizes risk and maximizes efficiency.

Useful resources

Carefully curated resources for TMF management professionals