The right Clinical Trial Management System (CTMS) can mean the difference between an efficient, well organized research program, or one that is struggling to manage and maintain the data for each of its clinical trials. With so many different types of CTMS programs on the market, choosing the best solution to fit your organization can be overwhelming.
Pricing is always the first and last question when addressing the addition of any new service within an organization. To understand the cost of a CTMS, you first need to understand what your organization requires from a CTMS and what the CTMS will require of your organization. Conducting a detailed analysis of your organization’s needs and capabilities will be essential in determining whether you will require a CTMS program that is more complex, customizable and costly, or more structured, easily manageable and less expensive.
When evaluating CTMS programs, consider the flexibility of the system and how that flexibility might impact its use at your organization. The more complex systems require significant configuration by the user, but also allow for significant customization in order to meet the needs of a more sophisticated research program such as a large hospital or health system. Before deciding on one of these systems, consider the capabilities of your IT department and whether your organization has the need and capability for such an undertaking.
Simpler systems will have less flexibility and opportunities for customization, and may have a more fixed or predefined structure with fewer decision points for the user. These simpler systems allow for a shorter learning curve for professionals with less experience operating CTMS programs and will be less burdensome for smaller organizations such as physician practices and hospitals with smaller IT departments.
Consider the following questions when determining what capabilities your organization will require:
- Can the system help in developing the study budgets?
- Can invoices and payments be documented and reconciled?
- Can the system track various protocol versions or each patient’s visit schedule?
- Can the system support both industry-sponsored and investigator-initiated trials?
- Can the system monitor the pipeline of trials not yet awarded?
- What are the system’s capabilities for ad hoc reporting?
- Are there facilities for exporting data, or real-time database access by external software?
While this list of questions is not exhaustive, if you find that you need access to most or all of these capabilities, it is likely you will need a more complex, customizable system. If you only need a few of these features, then a simpler, more structured system might be best for your organization.
There are many questions to ask when researching a CTMS to use in your clinical research program, but careful evaluation will help you pick the best system for your group at a reasonable cost. The most important consideration, though, is understanding the needs and capabilities of your organization. With that information at hand, you will be well on your way to finding the best match for your clinical research program.