Study Startup

Advarra's Study Startup is a clinical trial study startup solution designed to accelerate site activation timelines by providing immediate, shared visibility into every startup milestone—including ethics review—across all stakeholders. Built for sponsors, CROs, and site staff, it replaces fragmented, point-in-time tracking tools such as spreadsheets with a single, continuously updated platform that keeps every party aligned from day one.

At the core of the solution is a first-of-its-kind site-facing startup milestone tracker, delivered through Study Collaboration's expanded milestone functionality. Sites gain a clear, real-time view of their specific startup milestones—what is due, what is next, and what is complete—while sponsors and CROs see the same progress, automatically updated based on site activity, eliminating the need for constant manual follow-up.

Sponsor and CRO Capabilities: Milestone Oversight and Activation Control

• Track progress across all sites in real time, with actual versus planned milestone status clearly visible.
• Configure milestone templates by country, protocol, or site type to reflect the specific requirements of each study.
• Auto-integrate IRB approvals from CIRBI, with documents automatically routed to the eTMF.
• Generate audit-ready reports and monitor site performance centrally from a single dashboard.

Site Capabilities: Guided, Transparent Study Startup

• View required tasks and milestone progress through a clean, intuitive interface designed for site staff.
• Complete tasks flexibly in a manner aligned with site-specific standard operating procedures.
• Milestones update automatically based on real system activity, removing the need for manual status updates.
• Maintain a clear understanding of sponsor expectations at every stage of the startup process.

Integration with Core Source Systems

• Syncs IRB-approved documents from CIRBI directly into Study Startup, providing immediate insight to study teams on site readiness and automating the greenlight packet workflow—including non-IRB documents—to reduce back-and-forth bottlenecks.
• Milestones completed in Study Startup automatically update site statuses in the sponsor's and CRO's CTMS, keeping all systems aligned and eliminating double data entry while maintaining detailed operational visibility into site progress.

Key Benefits

• Shortens study activation timelines by reducing bottlenecks across IRB approvals, documentation, and stakeholder communication.
• Improves compliance through audit-ready reporting and automated document routing.
• Replaces siloed, static tracking tools with a single shared platform that reflects live system activity.
• Supports the full startup journey—from study activation and budgeting through coverage analysis and patient enrollment—enabling faster site activation.

Study Startup integrates directly with Advarra IRB (via CIRBI) and sponsor or CRO CTMS platforms, making it a deeply connected solution within the broader clinical trial operations ecosystem. By unifying visibility across sponsors, CROs, and sites in one platform, Advarra eliminates the reliance on disconnected trackers and ensures all stakeholders operate from the same, real-time source of truth throughout the study startup process.