Your Clinical Trial Management System (CTMS) is core to your clinical enterprise, so considering a new system is daunting. In many cases, this discussion leads to years of debate, including the most important question of all: “Do we keep what we have and invest more, or do we replace it?”

Whether you are considering a new system or simply auditing your existing one, here are some features that will be key to choosing the right CTMS solution for your business:

1. Cost:

Obviously, this is very important: your budget might narrow the discussion. Be sure you are comparing apples to apples, though, as pricing models are typically different across vendors (e.g. per named user vs per study).

2. Your Business Needs:

Know your requirements and how the business intends to use the CTMS. Some features you might want to consider are: Milestone Tracking, Regulatory Document Tracking, Tracking Patient Visit Schedules, Investigator Payment Tracking, Monitoring Visits, Clinical Trial Pipeline, Document Management, and Centralized Investigator Database.

3. Ability to Integrate:

To streamline your business processes you will want to integrate your CTMS with many other functions, such as: EDC, IVR, eTMF, or your safety system. Make sure your solution includes this capability.

4. Reporting:

Check that the CTMS solution has the reports you need now as well as the ability to easily create more reports as your needs evolve.

5. Data Exporting Capabilities:

Inevitably you will want to extract data from your CTMS, so ensure this process is easy and doable.

6. User Friendly and Easy to Learn:

As your system integrates and grows, there will be many users from potentially multiple organizations, so ensure the interface is intuitive to keep your training burden low.

7. Vendor Support Model:

Ensure that the vendor involved is well known and has a sturdy support model. Verify that they have coverage in the areas where you are doing (or plan to do) clinical research (e.g. helpdesk in Japan).

8. Structured for future growth:

Verify that your vendor has a process that monitors for updated regulations and adjusts the software as necessary. Understand how the system vendor does software releases and how that will impact your business team.

To help evaluate possible new solutions, I recommend finding a CTMS vendor who is willing to set up a conference room pilot. Then develop a scorecard based on your business requirements and have each team member rank the vendors — the vendor that scores highest is the winner!