Study Information System

SSS acknowledges that a critical component of clinical trial execution is the ability to view, analyze, store and organize large amounts of data, so we have developed our internal, validated, organized, web-based system, called Study Information System (SIS). The SSS’s Clinical Trial Management System (CTMS) is a flexible, and secure web-based software solution which allows us to manage all aspects of trial related activities including Regulatory Affairs and Ethics, clinical monitoring and safety, laboratory and biospecimen information, supply management, site payments, and regulatory documents management. By leveraging a strong business process management approach, these solutions improve inspection readiness and allow SSS to expedite clinical trial operations in a more transparent, efficient and compliant manner.

Depending on the employee job responsibilities, SIS layout will adapt, so that it can hide/reveal one or several sections. SIS provides data protection, confidentiality, data integrity and access to real time reporting. Security is provided by: security certificate, user and password security, user groups for specific rights.

SIS provides

24/ 7 secured and detailed access to real time information trough a customizable interface; data available only for authorized users.

Runs in standard web browsers, no installation required, accessible from both office and remote locations.

Large data storage capacity with consistent, real time data.

Provides regulatory compliance, validated.

Improves project management by keeping project progress under strict control, budgeting and forecasting.

Strong communication and tracking modules, allowing for shared understanding of site status, progress and performance.

Generate real time, predefined or custom reports.

Keep track of resources.

Keep track of all study contacts.

Automated alerts for preprogrammed processes and events.

Team roster with CRA-site assignments and workload.

In conclusion, SIS is capable of reducing administrative burden on study teams, creating optimized capacity for research projects.