STS is designed for companies that need to manage clinical trials monitoring visits reports and related information aligned with industry requirements such as CROs (Contract Research Organizations).
STS is a web-based system designed for the creation, review and approval of the monitoring visits reports develop during the conduction of Clinical Trials. It includes the scheduling of monitoring visits, and the access to the study database, where the action items, protocol deviations, safety information, SDV logs, monitoring visits reports submission/approval timelines can be consulted, and reports obtained to do a close follow on the trial status. This information can also be analyzed through customized dashboards for a deep analysis of the trial metrics, and relevant information in real time allowing to take important decisions in a timely manner.
In STS, CRAs (Clinical Research Associates) complete their monitoring reports without losing information, as it saves the information in real time, plan their monitoring activities and can consult the trial/site information with the use of the study database.
With STS, PMs (Project Managers) can handle multiple sites, review reports and manage trial information; additional staff can access to information to support planning and follow-up activities (e.g. CTAs) and perform oversight activities (e.g. Line managers, Quality Area). Within the STS, Monitors and Project Managers certify that all processes are carried out according to best practices by signing off tasks electronically.
As per trial requirements, the CRO can set up:
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