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Evaluate CTMS software like an IT pro – blog series: part 4

In this blog series we are sharing with you our 10 years of experience on how to evaluate CTMS software. In the last blog we talked about flexibility and fit. Today, in part 4 out of 10 we are sharing the final questions to ask before finalizing your shortlist. Read on to find out more about “Bells and whistles, the monitor visiting process, and how to evaluate the user interface.”

We’ve explored several questions so far, including:

  • why it’s important to want to eat a pizza with your vendor
  • why it matters how inputted data is stored, and questions about
  • how the vendor works together with you, the client.

Now it’s time to get down to the actual offering of the CTMS systems you are considering, in terms of optics and feel, process, and unique functions (we call these “bells and whistles”). This is the part where you’ll evaluate the overall look and feel of the CTMS and begin to imagine if your users will find it useful or not.

“If the software isn’t easy or if the processes doesn’t make sense, you’ll have a difficult time to get your CRAs to use it or use it properly.”

Jens B. Thuesen, chairman of BSI

An intuitive user interface increases user adoption

What does the user interface of the CTMS look like? Is it intuitive?

What is the training burden? We’re aiming for high adoption rates within your organization – which means better data for you. Better data helps you to keep trials on time and helps the organization to make more efficient decisions. If the interface isn’t intuitive, adoption rates will be low. A more intuitive interface also means a lower training burden.

Do you have CRAs? A common study site complaint is the high turnover of CRAs and the constant need for the site to “retrain” the new one on how to use the CTMS solution. A CRA who can quickly learn and effectively use the CTMS will be appreciated by your customer and ultimately decrease your overall organizational burden.

Data integrity reduces risk and increases compliance

Look for a CTMS system that utilize process-led data input. Process-led data input requires that one step is completed before the next step can be started. This minimizes the need for the user to remember specific steps and provides a process that ensures all data are correctly captured. The system should guide the user through the steps of creating a new trial, a new site, a new organization, a new person or a new task. Non-guided processes that require the user to take the lead with information input can require significantly more training and can negatively affect the quality of data and rate of user-error.

Training burdens in the range of 4-6 hours are a good indicator of an intuitive and user-friendly solution. Your users are also a good indicator of how intuitive the solution is. Ask them to test various CTMS solutions and get their input from their own unique perspective.

Data integrity is the foundation for compliance and risk reduction, it is also critical for effectively managing clinical trials and keeping them on track and on time. This starts with your users, and if it isn’t easy or if it doesn’t make sense, you’ll have a difficult time to get them to use it or use it properly.

How well integrated is the CTMS into your clinical applications?

Examine the monitor visiting process. Is it integrated from the start through to the electronic signature?

In this day and age your solution should have no disparate parts that require a user to piece them together. There should be no separate charts, excel sheets, or emails. Everything should be done in one process, with all alerts and tracking coming through the CTMS in order to cut down on error and reduce risk. This includes all communication such as email and phone calls, as well as the tracking of that communication.

Which special features are unique to that vendor’s solution?

There is no use in going through every feature, but it can be informative to understand how the vendor differentiates itself through various features. When making a list of your requirements, carefully choose those that are most important to your organization. Ask the vendor about their “signature” features. In other words, what do they do best? Can they customize features to meet your needs?

Up next: an introduction to how to price protect your organization

All articles in the blog series

  • Part 1: How to become a CTMS evaluation hero
  • Part 2: The killer criterion that immediately narrow down your list
  • Part 3: Are they going to march to your beat or will you have to march to theirs?
  • Part 4: Bells and whistles, the monitor visiting process, and how to evaluate the user interface
  • Part 5: The nuts and bolts of the pricing game

Next Best Action:

BSI Life Sciences




Jan Nielsen,
Community Manager Life Sciences

+41 58 255 96 22