Expert IRT/RTSM Setup and Customized User Acceptance Testing (UAT) for Pharma and Biotech Clinical Trials
Comprehensive IRT/RTSM Configuration and UAT Services: Ensuring Seamless Operations for Your Clinical Trials
In strict adherence to industry guidelines and standards, Sply specializes in providing sponsor-focused IRT/RTSM system setup and UAT. Our approach is tailored to integrate and anchor your unique processes and requirements, ensuring a solution that resonates with your needs.
At Sply, we prioritize clear communication and visibility at every stage.
Our approach to system configuration and UAT includes the implementation of rigorous risk controls.
We've crafted an end-to-end service designed to ensure transparency and active user involvement, delivering a comprehensive solution that exceeds your expectations.
Our service specializes in deciphering and implementing the User Requirements Specification (URS) provided by IRT/RTSM vendors. These specifications are crucial for aligning system configurations and customizations with the specific needs of your clinical study protocols and Investigational Medicinal Product (IMP) processes.
We believe the foundation of a successful IRT/RTSM setup lies in a mutual comprehension of both functional and user requirements. Our expert team excels in simplifying complex protocols, ensuring every detail is tailored to meet the clinical objectives.
Sply enhances IRT/RTSM UAT for clinical trials by utilizing a specialized UAT tool renowned for its comprehensive and user-friendly features.
This significantly boosts the efficiency and effectiveness of UAT projects, streamlining the creation, sequencing, and management of test cases.
Key advantages of using this specialized tool for UAT include:
Intuitive Interface: It's designed for simplicity, allowing testing on various devices, which empowers testers to work effectively, irrespective of their location or prior experience.
Advanced Reporting Tools: Offering real-time insights into the quality assurance process, this tool ensures that our team and all stakeholders stay updated with detailed and insightful test reports.
Integrated Issue Tracking: With its built-in issue tracker, the tool enables early detection and resolution of functionality and usability issues, making the UAT process more efficient and cost-effective.
Analytic approach to IRT/RTSM specifcations
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.
URS maintenance in case of protocol amendments
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.
Structured testplan and scripts
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.
Streamlined and efficient UAT execution
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.
Visibility during UAT
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.