Sply offers tailored solutions for companies seeking outsourced IRT/RTSM setup and customer User Acceptance Testing (cUAT) driven by technology
Let us set up, perform the cUATs, and keep your IRT/RTSM systems running smoothly
In compliance with industry guidelines and standards, Sply offers sponsor IRT/RTSM system setup and cUAT that incorporates and anchors your sponsor-specific processes and requirements.
To utilize the full potential of your IRT system, you need to maintain transparency in all aspects of IRT/RTSM management.
During system configuration, customer UAT we have incorporated risk controls, KPIs, and built an end-to-end service to deliver transparency and user involvement.
An IRT/RTSM vendor's URS outlines the system configurations and customizations required to match clinical study protocols and IMP processes. The key to ensuring a common understanding is to have a clear breakdown of the functional and user requirements.
Supports functional testing and ensures user requirements are properly implemented. For a clinical study to be successful, clinical study acceptance testing is essential.
Analytic approach to IRT/RTSM specifcations
A comprehensive review of the specification and formal documentation of the user requirements, including protocol design and stakeholder requirements. From the URS, all functions are captured, including randomization. The Sply team is experienced with reviewing the underlying system functions, integrations, and technical design specifications.
URS maintenance in case of amendments
Several trials require protocol amendments or unforeseen changes mid-study. Sply's involvement will help ensure that any changes to the IRT/RTSM system specifications are kept up to date.
Structured testplan and scripts
To minimize development risk and shorten lead times, we use a structured testing process focusing on error detection. Sply uses a test management tool for conducting, supporting, and controlling cUAT. The UAT plan and scripts are developed to cover all identified critical functions. Effective and user-centric test scripts and acceptance criteria are written in line with the URS and user flows/stories. In a visual traceability matrix report, the test scripts are correlated with the individual requirements. Sply will build and maintain a library of tests that can be reused for multiple trials - this will allow us to streamline and create test plans quickly.
Streamlined and efficient cUAT execution
Our test management system assigns and documents all test scripts, which will help guide the UAT process. To ensure efficiency, cUAT can be implemented using a risk-based approach.
Visibility during cUAT
All cUAT progress and issues discovered are tracked in real-time. Sply will provide key metrics and visual reports throughout the cUAT. Any issues found during the test are logged and retested in the test management system. Testing summaries and reports are shared with the sponsor team on a regular basis to ensure transperancy.