Electronic trial master file software enhances the work of clinical trial and medical affairs teams. By focusing on ease of implementation and customization of that software, the eTMF allows the team to focus on the trial, rather than on learning their way around a new platform.
Here’s what clinical trial teams need to know about ease of implementation and customization when looking for an eTMF.
Software is everywhere in daily life. Yet many workers aren’t prepared or inclined to embrace software that changes their familiar methods of working, says Craig Roth, Gartner research vice president. Given the choice, they will continue to use older, less efficient ways of working simply because they are familiar.
The switch from familiar to unfamiliar ways of working creates friction for workers. When software is difficult to implement or to learn, that friction builds. When the switch is too difficult, the entire process can grind to a halt.
Jack Wallen at TechRepublic recommends that anyone considering new software explore how easy the software will be to implement. Leadership can examine ease of implementation by asking the following questions:
Many leadership teams decide to acquire new software for the benefits it promises their teams. Yet choosing new software is merely the first step in realizing the software’s benefits.
Creating a software implementation plan is a vital second step toward a straightforward implementation of the new tools. In fact, “businesses that fail to define and achieve a software implementation plan might not realize the full benefits of the tool, risking lost time and money,” writes Collin Couey at Software Advice.
An implementation plan further smoothes the path for teams to adopt the new software. The plan should clearly state each step of the implementation process, acquaint teams with the new software and provide clear lines of communication for users who have questions or encounter problems.
All clinical trials face similar expectations when it comes to documentation, including accuracy, security and privacy controls, and the ability to respond promptly to an audit demand. Yet each clinical trial also faces its own unique challenges. An eTMF that meets the common challenges while allowing for flexibility through customization can help teams balance familiar demands with the unique features of their work.
As humans, we like customization and personalization. A University of Texas study by Laura Frances Bright found that people “do indeed perceive greater media enjoyment when exposed to a customized online environment as compared to a standard online environment.” The study indicates that two factors may be involved:
Customizable software improves a user’s sense of control. Users who log into a customized environment feel better able to handle what’s in front of them — even when the software is new and offers unfamiliar ways of doing older, familiar tasks.
Customization can also be used to reduce information overload, allowing users to focus on one task at a time. Tools like role-based access controls (RBAC), for instance, keep an eTMF’s user’s attention on the documents they are authorized to work with. When users don’t have to hunt through everything in the software to find what is relevant to them, they avoid information overload and can focus on carrying out their specific tasks in the new digital environment.
Acquainting users with new software, such as an eTMF, is only one implementation challenge. Another is addressing potential problems raised by the software itself, including the software’s interaction with existing software and hardware.
Customization offers an opportunity to improve the user experience by giving users a familiar tool even when they face challenges with its use. “No software solution is perfect, which means your employees will likely stumble across bugs or the need for additional functionalities as time goes on,” notes Vince Dawkins, president at Enertia Software. Customization gives users a way to stick with what does work while they seek help with what doesn’t.
Dawkins recommends regular updates and good communication with the software provider to address any bugs or need for improvement. A platform that offers robust customization options allows administrators to shape the user experience immediately upon implementation. These customizations can help your team do their job effectively until a more permanent fix, such as a software patch, is available.
Customization can turn the unfamiliar — a new eTMF platform — into the familiar. In doing so, customization gives your teams added support, so they can focus on their work, avoid information overload, and develop a constructive relationship with the new tool.
“Implementation of an eTMF provides an opportunity to move from a passive TMF management process used in a paper-based or archive eTMF to an eTMF that is fully integrated with business processes and other eClinical systems,” writes Henk-André Kroon, head of translational medicine at Annexon Biosciences.
This integration may feel overwhelming at first. By focusing on ease of implementation and by customizing key aspects of the eTMF, leadership responsible for the transition can help teams put the eTMF to use easily.
An eTMF that is easy to implement:
Recognizing their value, many software designers focus on ease of implementation and customization options when building an eTMF or similar tools. Software built in this manner can improve implementation and use by clinical trial teams.
Yet ultimate success in an eTMF implementation lies less in the software than in the teams and their leadership. A clear plan for implementation, explanations describing what the software replaces and why, and transparent communication all provide a strong foundation for a successful eTMF implementation.
Despite the challenges, the primary concern in implementing an eTMF does not lie in the software itself. Rather, “the mistake is not moving from traditional TMFs to eTMFs,” warns Byron Mignanelli, cofounder and CEO at Global Strategic Management Institute. By focusing on how the eTMF supports its users and their work, leadership can ensure they embrace ease of implementation and customization for their maximum value.
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