Today’s technology has unlimited benefits to add to the world of clinical trials, but CROs and sponsors need to ask the right questions when choosing a software provider. Your provider needs to consider the details of your study and provide customizable software to ensure successful application. Consider the following three questions every medical software provider should be able to answer.
1. Can the software be customized?
Because every trial demands unique features and functionality, the software chosen must be flexible enough to customize, yet furnished with templates and tools that empower study subjects to record their data accurately and efficiently. For example, your trial might demand software designed to record data on breathing difficulty. The generic version of this app is then customized to fit the trial. Can you trust that this altered software will perform the same across every type of device? Can you ensure that proper notifications and alarms will regulate the participants’ data entries? These questions need to be addressed by your software provider but the simplest way to safeguard your data for every participant to use the same device so that customized or altered software programs aren’t compromised of different devices.
2. Are training and support services included?
Any time a study site adopts new software, there’s a period of adjustment during which site staff may need to rely heavily on training and support from their provider. Advanced Data Systems states that the ideal training and support packages include “self-services options – access to online FAQ lists, forums, and educational resources 24 hours per day, and live tech support.” It’s important to ask for what works best with each individual study format, whether that involves support on-site, online, personalized sessions, or a combination. The future may just be in entirely virtual trials. Site monitors can make visits to the patients’ homes, but most data will be collected by the patients themselves. Furthermore, if various devices are used, such as in the BYOD model, the IT department will need to be versed in addressing every possible issue that could arise from every available device. Without this support, patients might be unwilling to continue with trials. As patient retention is one of the main concerns of trial organizers, it is essential to maintain a positive experience for those involved. Given that nearly 5,000 types of mobile devices are used by millions of healthcare providers around the world, device-related problems are inevitable. For this reason, software providers should be prepared to customize their software for each type of device.
3. Are there protective security features in place?
Today, thanks to the “dark web,” information found in personal health records is more valuable than credit card numbers. When choosing a provider, find out how they address breach prevention online and how often they install patches and fixes for desktop solutions and hybrid networks. Don’t be afraid to ask the provider if there has ever been a significant data breach and what known vulnerabilities, if any, exist. Of course, ensuring data security is much easier when working with uniform provisioned devices as opposed to the BYOD approach. With the provisioned solution, sponsors and CROs can maintain control over the devices whereas the BYOD approach allows the study participants to have the majority of control. This increases the risk of compromising data and makes tech support and security maintenance far more complicated.
While mobile health technology could revolutionize how the clinical research industry conducts clinical trials, success relies on the industry’s focus on building a positive participant experience. Regardless of whether mobile health is incorporated into study design, it’s essential for software to be designed with the participant’s best interests in mind.