As a company that develops clinical research software, it’s easy for us to tout why a site needs our products to help manage their clinical research operations. However, are there ever times when a clinical trial management system (CTMS) is not appropriate? Of course. Though the industry as a whole is adopting more and more technology, there might still be reasons you may not need a CTMS:
1. You’re a (really) small site.
A CTMS helps streamline the communication between all staff members and various departments. If one person is out of the office, work doesn’t need to be put on hold because the information needed is on the computer. The CTMS is a central place where all staff members are able to access the operational data of a trial. If your site is a one-man (or woman) show, or if it’s just you and one or two other staff members, you may not have any communication problems. Perhaps the one or two individuals conducting a trial have the time and know-how to manage all aspects of the protocol – from start-up activities to close out, and from visit management to financial management. If this sounds like you, then a CTMS may not be the best investment for your site.
2. Your staff is easily able to complete their work in the time allotted.
In addition to streamlining communication, a CTMS helps increase productivity by saving staff time with features such as visit recalculations and automatic reporting. Often, these tasks and other administrative responsibilities can take up valuable time throughout the day, reducing the amount of time spent on patient care. If, however, your staff has a very balanced workload and is able to complete all tasks that are handed to them during the workday, then you may not need a CTMS to help improve efficiencies. Unless, you’re looking to expand…
3. You don’t have plans to grow.
Perhaps you’re not interested in growing your research operations. If you are comfortable with the number of patients you have, the pace of your day, and your current work/life balance, you might not need a CTMS – and that is perfectly fine. Adding a CTMS at your site may upset this balance, and most likely will not be fully utilized for just that reason.
4. Compliance has never been a problem for you.
A CTMS can help with compliance matters, in terms of the management of essential documents such as IRB reviews, CVs of investigators, and informed consents. If you’ve never lost an important paper or come across an expired form, kudos! The way you manage your documents is working great and perhaps you’ve found a method that would challenge the need for a CTMS. However, like most sites, it is difficult to track all the paperwork associated with each protocol, which is where having a central repository for all documentation can become extremely helpful.
For everyone else…
If you don’t fit into the above categories and you aren’t already using technology to manage your research operations, it may be time to consider the benefits that a clinical trial management system can offer. A CTMS can greatly improve the productivity at a site by streamlining workflows and saving valuable staff time. It can also scale with your business, as it simultaneously aids in the business development efforts that allow it to grow.
Author’s note: This article was originally published on 8/1/13.