How Much Does a Clinical Trial Management System Cost?

• Up Front Costs – Are there charges to initiate? Will you be invoiced before the system is available to you? Options exist with no up front costs.

• Term Commitment – Does the vendor require a multi-year commitment? Are there penalties if you need to terminate early? Options exist with no multi-year commitment.

• Recurring Costs – What factors impact recurring charges? Number of users? Number of studies? Do you have control over the recurring costs? How will the vendor be transparent with you about long term costs?

• Add-In/Optional Fees – Are there additional charges for training, integration, customization, validation, etc?

1. Up Front - Setup/Initiation Fees

Both On-Premise and Dedicated SaaS-based systems typically include a one-time initiation or installation fee. Be sure that the vendor clearly defines what they are providing in this area, as fees vary widely and may be significant. For Dedicated SaaS-based systems, this may include the complete deployment and basic setup of the system, which can be a significant value for firms that want to minimize internal IT and server costs. On-Demand SaaS based systems typically have low to no (zero) setup/initiation fees, because the system is already deployed and available.

Consider whether additional deployment and setup/customization costs will apply.
Do you have to hire a systems integration specialist or IT resources? Do you have to buy hardware? In addition to the financial outlay, there can also be productivity costs while you wait for the system to be setup and deployed. From a cost perspective, most SaaS-based products score well in this category, with minimal implementation costs and quick deployment timeframe.

Most clients need some level of customization, to ensure the CTMS fits the unique study and organizational needs. Products that are designed for flexibility will allow the client to directly customize the system based on per-study and per user needs. However, some systems may require “programming” to customize the system, which can carry a significant price tag. Ask the CTMS vendor how they handle system customizations

2. Contractual Term Commitment

Does the vendor require a multi-year commitment? If so, consider the total cost of your commitment over the contract period. Are there penalties if you wish or need to terminate the agreement during the contractual term? While an extended contract agreement may be required by some vendors, you will find other vendors who work to keep your business through an effective product and great service, while offering flexible subscription pricing. For maximum flexibility and minimal commitment and risk, look for an On-Demand or Dedicated SaaS vendor that does not require a contractual term.

3. Customizations

Most clients need and want a significant level of customization, to ensure the CTMS fits the unique tracking requirements for your study and team. Products that are designed for flexibility will allow the client to directly customize/configure the system based on per-study and per-user needs. However, some systems may require programming to customize the system, which can carry a significant price tag (and timeline). Ask the CTMS vendor how they handle system customization and configuration.

4. Per-User Fees vs. Per-Study Fees

CTMS fees are typically based on the number of users and/or studies. It is best if you can estimate the number of active user licenses needed as well as the number of studies. For the SimpleTrials CTMS, we have automated the study build process, so there are no per-study fees (but instead there are caps on the number of studies, based on your subscription plan (e.g. 25, 50, etc.). SimpleTrials allows clients to upgrade or downgrade the number user licenses anytime, in groups of 5. The system can grow with you, and the cost is scalable. Other systems may require a fixed number of licenses determined up front (not ideal, since your user base is likely to ramp up and down).

5. Per Module / Feature Fees

It is common for clinical software providers to offer a variable feature set or “modules”. Ask the CTMS provider whether whether you are paying separately for each module. How much does each module cost, and are any modules optional? At SimpleTrials, we provide a number of options, but we also keep our offerings simple by including a core set of CTMS features and an integrated eTMF (electronic trial master file) in all subscription plans. SimpleTrials also offers affordable premium plans which includes a comprehensive feature set for study management, monitoring, payments and eTMF.

6. Training and Support

Consider the costs of getting your user base up-to-speed and productive on the system.  Does the vendor provide training?  Is training included in base license/setup fees, or is it an additional cost?  

Training can be critical for successful adoption of a CTMS, and different models/formats exist.  In any case, training is an important consideration as it may carry significant cost (which is not always included in the basic “sticker price”). Do the trainers have depth of experience managing clinical trials as well as CTMS product expertise, so that your training hours will be relevant and efficient.

Product support can be critical to ensuring the productivity of your team on a day-to-day basis, and there can be a wide range of support options, costs and quality.  Ask the provider about the support options and costs.  SimpleTrials includes user support (e.g. help desk) and a vast library of support tools (e.g. features videos, searchable knowledge database, and user guides). All of these items are available in all subscription plans at no additional cost. 

7. Validation / 21 Part 11 and Privacy Compliance

Validation and compliance are complex subject matters and we recommend consultation with a quality expert to help determine your specific needs. Beware of vendors promoting a compliant “out of the box” solution. Compliance experts advise that a properly validated system requires a collaborative effort between customer and vendor. System validation can be an expensive process and must be factored into your budget. With SimpleTrials, your team will have a purpose-built and robust application that supports the technical controls for 21 CFR Part 11 compliance, adheres to GDPR privacy needs and remains in a validated state.

8. System Integration Fees

The CTMS is typically one of many eClinical systems in use, and therefore must integrate and share data with your other systems. Be sure to consider the integration costs, which may include API and Data Connector fees. Some systems include APIs and common connectors at no additional charge, but others charge a significant up-front or monthly fee. If you have custom integration needs, you may need to factor in the cost of a specialized systems integrator. With SimpleTrials, out-of-the-box integration is available with over 15 EDC vendors and our API is available when you need it.

9. Maintenance

Product maintenance is critical for correcting defects and enhancing the system. Optimally, you want a vendor that is continually improving the system, but you must consider whether the vendor will charge you when updates and/or new versions are available.  You will likely find SaaS-based products to be less expensive and more streamlined in this area, since maintenance is typically include in the “service” part of SaaS. 

10. What will it take to get a price quote?

Sadly, many CTMS providers hold their pricing close to the vest. They may claim that allows them to customize a pricing solution that offers you the best deal. But really, it allows them to optimize revenue from the deal, and the lack of transparency makes it difficult to know when you are being overcharged. With SimpleTrials, we put customers first by offering published, flat pricing, available directly on the SimpleTrials.com website.