Our approach includes an exhaustive review and of all user requirements, encompassing the intricacies of protocol design and the diverse needs of stakeholders. This comprehensive process ensures that every aspect of the specification is analyzed and integrated to support the success of your clinical trials.

Many clinical trials encounter the need for protocol amendments or unexpected adjustments midway through the study. At Sply, we are dedicated to ensuring that any such changes are promptly and efficiently reflected in the IRT/RTSM system specifications. Our proactive involvement guarantees that your trial's progress remains seamless and up-to-date, regardless of any unforeseen modifications.

To mitigate development risks and accelerate lead times, Sply employs a structured testing process with a keen focus on error detection. Utilizing a sophisticated test management tool, we conduct, support, and control UAT with precision and efficiency. Our UAT plans and scripts are created to comprehensively address all critical functions identified in the project. We develop effective, user-centric test scripts and acceptance criteria that aligns with the Unique Requirements Specifications (URS) and detailed user flows/stories. This approach ensures that every test is relevant and targeted. In our visual traceability matrix report, each test script is methodically correlated with the corresponding individual requirements, providing clear and coherent oversight. Moreover, Sply is dedicated to building and maintaining a reusable test library. This resource allows us to swiftly tailor and deploy test plans across multiple trials, significantly enhancing our ability to streamline processes and respond rapidly to the dynamic needs of each study.

Our test management system meticulously assigns and documents all test scripts, streamlining the UAT process with clear guidance and structured oversight. To optimize efficiency, Sply implements UAT using a risk-based approach, focusing resources where they are most impactful and ensuring a swift, effective testing phase.

Sply ensures that all progress and issues identified during UAT are meticulously tracked in real-time. This approach guarantees immediate attention and resolution of any concerns. Throughout the UAT process, we provide comprehensive key metrics and visual reports, keeping all stakeholders informed and engaged. The test management system is designed to log any issues encountered during testing, with each one being promptly retested to ensure thorough resolution. To maintain transparency and collaboration, we regularly share detailed testing summaries and reports with the sponsor team, fostering a clear and open line of communication.