During clinical trials, randomization and trial supply management (RTSM) solutions help randomize the participant allocation and make sure the study design is balanced and trial supplies are available when and where they are required. A key piece of those efforts is the usage of interactive response technology (IRT) software.
Conventional RTSM study build processes follow a sequential, waterfall approach that could be quite time-consuming. Business analysts work with vendors to write study requirements and specifications, which is followed by a build phase to implement those requirements. A final validation period verifies the needs.
Vendors previously attempted to streamline these processes using web-based configurations that permit companies to quickly set up trials. Some of these tools allow studies to be set up without custom coding, removing the extensive development time required to write new software for every individual study. To mention, creating lengthy specification documents before starting the study could create inefficiencies, generate unnecessary customizations and lead to significant re-engineering of the study after the testing phase.
Current approaches to IRT based on traditional methodologies could introduce extra costs, time and errors into the study build process. A novel and agile approach that involves customers quite early in the development cycle could result in improved quality, faster deployments and lower overall costs. This agile approach, which is based on existing agile software development methodologies and principles, could reduce the back-and-forth that occurs during the user acceptance testing (UAT) and quality control phases.
The agile model encourage adaptive planning, evolving development and the use of functional software in vendor/client interactions rather than the development of specification documents prior to the study build. The client could evaluate this software demonstration and provide immediate feedback that could then be used to rebuild the study. And while there might be some cost associated with that rebuild effort, the cost is relatively low enough that the specifications don’t have to be perfect in advance of the study build. Once the build process is complete, the final specifications could be constructed to align with the as-built study exactly, which results in a faster sign-off and approval process.
Theis approach not only improves the process efficiency, but ultimately results in a higher-quality study. By streamlining the process and getting clients involved earlier, the following benefits could be realized:
1. Higher Efficiency and Quality
While this IRT approach makes the build process faster, speed is not definitely the primary force. The real benefit is that it enhances the efficiency of the entire process.The time spent building the study is quite productive, and there is less waiting between process steps. It also improves the quality of the finished product because the team could focus on solving problems rather than the development of intricate specifications.
2. Earlier Problem Resolution
With the software right in front of them, the study team could immediately spot errors or identify incorrect assumptions they made early on in the process about the structure of the system. They could also avoid overlooking flaws in the study that might otherwise be missed in UAT.
3. Faster Project Completion
The study could be configured much more quickly, which could significantly lower study build time. While a standard study takes 6 to 8 weeks to build, an agile approach can often be completed in much lesser time.
4. Lowered Customization
Clients have a chance to see that the core configurable IRT system can meet most of their requirements without a high level of customization. By seeing the working of the system quite early, they can visualize how the solution could meet their needs.
5. Lesser UAT Findings
The collaboration provided by agile IRT must result in a UAT phase with fewer findings and less redevelopment. This further streamlines the process because clients don’t have to dedicate resources to testing for lengthy periods of time.
6. Lowered Time Investment
The client spends lesser time on the study build process. While an agile approach needs a greater level of collaboration and availability on the part of the client, it ultimately lowers their investment in time and resources by lowering the effort needed for multiple rounds of specification development and multiple UAT cycles. A high quality study also reduces the maintenance effort needed to run the study.
IRT software helps streamline and simplify the RTSM process, but the reliance on developing elaborate specifications documents before the study build adds time and cost that can be avoided by improving collaboration between researchers and the study build team. Agile IRT could lower the cost and time neede for the study build process while also leads to a higher quality study with fewer UAT findings.
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