CTDM (Clinical Trial Data Management) is a crucial stage in clinical research, which aims to ensure the generation of statistically sound, reliable, and high-quality data from clinical trials. CTDM also ensures data availability, integration, and collection at the appropriate costs and quality.
Regulatory compliance is one of the main purposes of EDC clinical trial software testing. While dozens of testing methods help ensure compliance with software that clinical trials use, this blog focuses on UAT.
What is UAT?
This is usually the concluding step when developing a specific feature. During UAT, people from the intended target audience are requested to use the application. The users then make a note of any defects that they come across. Thus, this testing allows users to interact with the application and see if everything works as intended. This process can help discover various aspects of features, including those that could’ve been defective, miscommunicated, or overlooked.
Benefits of automating UAT
CROs and sponsors face several challenges in running successful clinical trials, including data management, changes in regulatory guidance, business transformation, and market competition. Innovations that mitigate inefficiencies during the clinical trial process can offer a competitive edge as they can speed up a therapy’s time to market. Following are some of the disadvantages that come with doing UAT manually:
- Some parts of the EDC are usually validated again, which leads to redundancies.
- Multiple workflows, guidelines, and SOPs that are typically sponsor-specific can generate inconsistencies, which may prevent you from quickly finalizing the UAT process.
- Due to the absence of industry testing standards, you may have to write test scripts from scratch, leading to non-standardization.
Fortunately, automated UAT can mitigate most of the drawbacks discussed above while offering a superior testing solution that comprises:
- Shorter submission timelines — while manual UAT requires weeks, automated UAT gets the job done in a matter of hours.
- Mitigates risk of error.
- High-volume testing, which produces high-quality UAT reports.
- Repeatable, streamlined processes that can easily be implemented across studies.
By automating UAT, you can make your study more successful — and with the right partner, it can be a rewarding, smooth experience.
ClinicalPURSUIT’s EDC software for clinical trials offers all the features required for successful clinical trials
From intelligent electronic data capture to rapid study development, ClinicalPURSUIT’s EDC clinical trial software differs from typical solutions due to its advanced features that ensure successful clinical trials.
Give us a call now for more information on our clinical electronic data capture software!
