Investigator-Portal

Investigator-Portal is a module developed by Atlant Systems as part of the @Protocol clinical trials management system. It is designed to facilitate collaboration between clinical sites, sponsors, and CRO partners by providing a secure, shared workspace where site personnel can access and interact with trial data relevant to their patients and staff.

Clinical coordinators access a single screen that presents a complete view of the trials they are conducting. This includes the status of regulatory documents (received and expiring), upcoming CRA appointments, patient visit schedules, and current enrollment information. Sites can also update patient visit data, report screen failures, flag potential protocol deviations, and submit adverse event alerts directly through the portal. All data displayed is in real time.

Key Features

• Intuitive interface: A single screen provides a complete picture of ongoing trial activity for clinical coordinators.
• Real-time trial information: Data is updated continuously, giving both site and sponsor teams up-to-the-minute visibility.
• Secure log-in: Access controls maintain data privacy, including between individuals at the same site.
• Digital signatures and FDA compliance: Users entering data can digitally sign forms and documents to meet FDA requirements.
• Inter-site discussion forum and FAQ center: Supports communication between investigators and sites to reduce confusion and improve coordination across the trial network.

Data Flow and Integration

• Data entered by site personnel is passed directly to the central trial repository managed by the sponsor or CRO.
• Information is automatically incorporated into the database without requiring manual re-entry by the sponsor.
• Data is checked and verified at the point of entry before being transferred to the central system.

Broader Platform Context

• Investigator-Portal is a module within the @Protocol clinical trials management system.
• @Protocol covers end-to-end trial management, including resource and budget planning, financial and site management, monitoring, document tracking, and time and expense reporting.
• The portal extends the platform's capabilities by adding site-level collaboration and data entry functionality.