You’re having trouble managing the trial master file for your clinical trial. But how do you know if you need an electronic master file (eTMF) solution to help? It may seem like a simple answer, and maybe it is – if you’re looking at the right things. Here are five signs you need eTMF software.

(Agatha’s head of North American operations, Ken Lownie, held a webinar on this topic, so we thought we’d share some of the highlights.) 

First, let’s set the stage.

What is a TMF?

The trial master file is like a central filing cabinet where you store all the documents, forms, and files for a clinical study. These essential documents are created throughout a clinical study by the sponsor and their staff, the CRO and their staff (if you use one), and the clinical sites. 

Essential documents are the evidence that the study was conducted in compliance with regulations and include documentation of information such as:

  • The steps that were taken during the study
  • Protocols used
  • Investigator compliance
  • Qualifications of the primary investigator
  • And more.

What is eTMF Software?

An electronic trial master file (eTMF) is a digital version of the TMF. It’s software. But it’s much more than a filing cabinet to store documents. It’s a system and set of processes that ensure those documents are collected, reviewed, and approved, that eSignatures are captured, and quality checked.

eTMF software has been around for over thirty years. These solutions have been through a series of evolutions that have taken them from custom applications built on complex enterprise platforms like Documentum and OpenText to packaged applications that sat on top of SharePoint, to cloud-based enterprise platforms such as Veeva, to today’s generation of ready-to-use applications. 

Today, many eTMF software solutions are available (even those large enterprise systems are still around). But here’s the thing. The evolution of these solutions has always been to support IT, to make it easier for IT to implement and manage them. It was not to make them easier to use for the business users.

And that’s where today’s fourth-generation eTMF applications come into play – making it easier for the business to set up and use the eTMF to improve the management of their clinical trial TMFs.

5 Signs You Are Ready for eTMF Software

Let’s get down to the critical point – are you ready to implement an eTMF? Do you need to? 

Are You Storing the TMF in Non-Compliant Systems?

If you use shared network folders, SharePoint, or Dropbox, and email to collect and manage your TMF documents, then it’s time to think about an eTMF. These systems are not purpose-built to manage the TMF, and they are not compliant with standards like 21 CFR Part 11 (this regulation relates to how to capture and store electronic signatures).

Are You Increasing Headcount to Manage the TMF?

When you manage your TMF through paper or some combination of paper and digital (like spreadsheets), you’re likely stressing your team out trying to keep everything in sync and up to date. Maybe you’re thinking of adding headcount to help them out. 

Manual processes always take more time. And they are prone to human error (especially when those humans – CRAs, document managers – are pressed for time).

Are You Stressed Over a Potential Audit or Inspection?

Do you find yourself waking in the middle of the night worrying about a potential audit or inspection? You can’t say for sure that you have everything exactly the way it should be, and there’s no way to find out what’s missing when you manage using paper or hybrid approaches.

Are You Ramping up Clinical Trial Activity?

Maybe it’s your first trial. Or perhaps you’re moving to later stages of a clinical trial or adding new trials to manage. More activity means more work, and more manual work isn’t what your team needs.

There are also situations where you decide you want to in-source your TMF from a CRO to reduce costs or increase your level of control and quality. Bringing the TMF in-house comes with its own set of challenges but is beneficial for many sponsors.

Are There Rumblings of M&A or New Investment Activity?

When you are a small or early-stage pharmaceutical, biotech, or medical device company, you’re likely to be acquired. Or you’re going for more funding from venture capital firms. In either case, these companies will do their due diligence on your company, and that includes examining your TMF closely to ensure you are a good candidate. 

Convincing Management to Invest in eTMF Software

You’re convinced it’s time to implement eTMF software. But how do you convince management? It’s not unusual for the CEO or CFO to minimize and simplify TMF management – after all, they aren’t doing the work. To show them it’s time to invest in an eTMF application, consider the following:

Do a Cost-Benefit Analysis

The first thing you can do is a cost-benefit analysis. If you are looking at a SaaS-based eTMF (which you should be), then you are looking at costs such as:

  • Yearly subscription cost
  • Implementation costs, including training 

For benefits, you’ll want to look at things like:

  • Reduced paper handling and storage costs
  • Improved staff efficiencies
  • Faster study startup
  • Reduced CRO costs
  • Elimination of audit/inspection prep time
  • Reduced audit/inspection time

Tie the Purchase to Business Risks and Objectives

Your CFO and CEO think in terms of how things affect the goals of the business. And that means you need to speak to them in those terms. Some things to consider as you identify your business objectives and risks:

  • Risk of non-compliance
  • Acceleration of the trial process
  • Looking like a good candidate for M&A or investment
  • Developing more efficient and effective staff

When You’re Ready – Here’s What to Do

Let’s assume that based on the signals, you know it’s time for an eTMF software solution. Now what? Here’s the evaluation and selection process; Customize it as it works for you.

Current – Future State Analysis: Document where you are now and where you would like to be, then identify the gap and the work needed to get you from your current to your future state. Acknowledge that you can’t do it all in one go. It will take time, so determine the best path to get you where you want to be.

Create a Proposal/Pitch: Create a proposal to present to management to get their approval to move forward. Include an educational element to your proposal – like a TMF 101 – to ensure everyone understands what’s required.

Create the Selection Team and the Extended Team: Once you have the approval to move forward, establish a small core team to evaluate vendors. You’ll also want an extended team that includes your management. These are key stakeholders you’ll need to work with and keep informed of your progress.

Build a Budget: Identify the budget you’ll need at each key stage you’ve identified in your future state process.

Evaluate Potential Vendors: Select a few vendors you think are a good fit based on your research – don’t go over 3-4 vendors or you’ll find yourself overwhelmed.

Try before you buy: Once you’ve selected the vendor of choice, do a free trial using your actual data to ensure the eTMF application is going to work the way you need it to.

Do the Deal: Once you are satisfied with the trial process, negotiate your subscription and plan your implementation. Don’t forget to include training for all staff as part of this process.

There was plenty of great information in the webinar, 5 Telltale Signs You Need an eTMF.

Watch the full replay on-demand. You can also download our guide, The Essential Guide to a Fourth Generation eTMF.

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