CTMS, or Clinical Trial Management System, is a major category of clinical trial solution on the market.
These CTMS are used by clinical stage pharma companies who have larger trial portfolios that need more oversight. This group is mainly made of medium to large pharma companies.
However, increasingly, small pharmas are starting to deploy these systems upon initiating their first trials. There is now more of an attempt to build efficiency and standardization into their clinical operations department from the onset, instead of scrambling to deploy one when time comes to scale. CTMS are also used by CROs and FSPs.
In this article, we discuss several key criteria to consider when it comes to choosing a CTMS:
Is the CTMS purpose-built, easy to use, and work streamlining?
The first CTMS were developed by CRM providers.
CRMs, or customer relationship management systems, are the main software used by sales teams across any industry. CRMs’ primary purpose is to help sales teams manage the numerous sales contacts, conversations, and related materials.
For this reason, many modern CTMS have inherited a “CRM-type” feel about them. Unfortunately, sales and clinical operations are different functions with dissimilar needs. Clinical trials are all about clinical trial data, tracking, oversight, and some internal/external communication. Because of the retrofit of clinical operations features into a CRM design, many clinical trial management systems appear clunky and needlessly complex.
For this reason, it’s important to scrutinize the following during a live demo:
- Is the UI (user interface) intuitive or confusing?
- How much time does it take to navigate to key features or data?
- Can the CTMS realistically replace any spreadsheets the study team is maintaining or will it only be able to house a subset of the information currently tracked?
- Does it seem like the system will actually save time/effort and reduce complexity as compared to current processes?
Does the CTMS provide ROI?
Return on investment with systems such as CTMS can be hard to quantify through user surveys. Study teams usually aren’t accurately tracking how many hours they spend on specific tasks pre- and post-CTMS deployment. For this reason, many case studies are anecdotal rather than empirical.
Reading case studies is a good starting point for prospects, but the point remains that a company doesn’t know how a CTMS will work for them specifically until they try it.
This is why we recommend piloting the CTMS on a single, “average” study (as defined by the client) and asking the pilot’s stakeholders at various points how they feel about the product.
Remember, the stakeholders of the CTMS pilot should include members from the frontline study team (CTMs, CTAs, etc.) and clinical operations (and perhaps even company-level) senior leadership, as both groups should be benefiting from the system:
- How smooth was the configuration process?
- How easy was the system to learn?
- How easy it is to use?
- What did the CTMS allow you to do that you weren’t able to do before?
- What systems or processes have you stopped using since the system was deployed?
- Do you have less busy work or more? Do you have less work overall or more?
- Are you more or less efficient in general?
- Are you happy that the system was implemented and would you want to use it again?
How Does the CTMS Handle Data Inputs?
Clinical operations teams already deal with “system overload”, having to navigate to EDC, IRT, and various applications and files.
That said, it’s good to consider if a CTMS will be able to pull data in from external sources to collapse some of these processes. Further, pulling in data will limit the amount of manual and/or redundant data entry that teams will need to do. Related questions to consider:
- From which sources can it pull in data?
- How does it pull in data?
- How is external data validated?
- Are there limitations to the types of data that can be pulled in and from where it can be pulled in and why?
Does the CTMS have automation or unique features/services?
It can be hard to differentiate between CTMS because they all seem to have standard dashboards and listings. However, there are always differences – some nuanced, some obvious:
- Are there any automations that help teams limit their usual busy work, e.g. manual data entry or other repetitive and low value-add tasks?
- Are there unique features that aren’t found in other systems? If so, how useful are these?
- What configuration services are provided?
- What ongoing services are provided?
- Are any personnel assigned to your study who have clin ops experience?
What are the CTMS compliance, security, and validation measures?
It goes without saying that any system used in clinical trials need to show adherence in the areas of compliance, security, and validation.
This is true even for systems such as CTMS, that are used to house “working data” (and used for oversight) rather than data that will be included in a regulatory submission, such is the case with EDC.
Conversely, it’s also known that clinical operations teams frequently use spreadsheets yet don’t subject them to this rigor. However, there is always a risk that a health authority will ask about controls around any digital tool used in clinical trials. Because of this, and to generally assess “IT health”, we recommend always asking about the following:
- Privacy regulations:
- GDPR
- CCPA
- Health authority regulations:
- 21 CFR Part 11
- HIPAA (if the CTMS pulls in subject identifying information, e.g. from an EMR)
- IT Validation
- GAMP-5 is the industry standard documentation format
- IT Security
- What security certifications and controls are in place?
