Director of Quality, Interpace Biosciences

John R. Nocero, PhD

A good eTMF vendor can make your TMF look like a million bucks if done correctly, improving audit findings and general business practices. While a bad eTMF vendor can stress your clinical team out and cost you more than money. Organizations must find an eTMF vendor who is attentive to you and your clinical team and Trial Master File requirements. It can be overwhelming researching the BEST eTMF vendor for your study.There are so many vendors, and they are not all created equal. Some have more options than others. Some are easy to use while others are more complicated. How do you know which one is right for your study? Here is our list of 10 questions you should have answered before you sign a contract with an eTMF vendor to make sure they are a good fit for you.

These questions are not meant to be asked outright. In fact, some of them will probably be answered right on the eTMF vendor's Web site or within the first introductory e-mail. These questions are intended as a guideline to help you get thinking about what's important for your eTMF vendor selected.

We highly recommend that you test the eTMF before signing a contract. You want to make sure that the system is easy to use and offers all of the functionality that you are looking for. This will alleviate any stress to ensure that the system provides a good user experience and how the system operates. This will also allow for the team to discuss the pros and cons of the user functionality of the system to commit to this vendor or continue the search.

Do not sign a contract with an eTMF vendor if their fees are confusing or it is not clear. Do not be afraid to ask lots of questions:

Do they charge based on how complex the study is? Think a la carte.

What if you decide the eTMF vendor you selected was not the right choice? Is there an additional fee for not committing to your X-year contract?

Any good eTMF vendor will be happy to provide you with at least 3 references. If they are hesitant this is a red flag. Once they provide you with references, you must contact them and ask them questions about the system. For example,

"Have you gone through an audit when using this system?" If so, how helpful was the eTMF vendor assisting you with this?"

"What is your favorite part about this eTMF system?"

"Why did you choose this eTMF vendor over another vendor?"

"On a scale of 1-10, 10 being the best, how would you rate their customer service?"

In other words, if you have a question about the system, how quickly can you get it answered? Are you expected to read an article or a video or will a real person be available to help you? Will the help desk be able to jump on a quick Zoom call or a Teams meeting where you can share your screen to troubleshoot your issue?

There's nothing worse than having a system update during working hours. The goal of TMF inspection readiness is to file documents in real-time and if your eTMF system has hours of updates during office hours this is costing you time and money. You want to make sure that it is done during "off hours" or on a weekend.

It's important to know how long it is going to take to implement the system and how long training will take.

Being compliant with 21 CFR Part 11 is an important feature of an eTMF system and you are going to need to ask and will they be able to provide you with documentation. If so, has the system been validated? Even if they provide you with validation documents you are going to want to do your due diligence on validation and UAT.

Security should be the #1 priority when it comes to document management. Questions to consider:

How secure is their network? When you log into the system, do you see" https"?

Can the system produce audit trails to see who has logged in, viewed/edited/deleted documents?

What types of permissions/permission groups does the system have?

Speed is of the essence in clinical trials. It's important to track cycle times with them too. In other words, how quickly does the vendor respond to your emails? Other things to consider:

What is the tone of the email/phone conversation/virtual meeting?

Do they get frustrated when you ask questions or are they able to respond in a compassionate manner?

Selecting the right eTMF vendor for your study can save you time, and money, and reduce stress. Asking the right questions and documenting your assessments of the vendor and comparing/contrasting the pros and cons of each system will help you analyze and ensure that you chose the right vendor for your study.

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The many different shapes and sizes of vendors requires a thoughtful process for selection.

John R. Nocero, PhD

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10 Questions to Consider With eTMF Vendor Selection