CTMS / eTMF
and Trial Operations

Effective clinical studies start with realistic planning and the right site selection. With Galax CTMS, we streamline country and site feasibility assessments, capturing interest, capabilities, and historical performance in a structured format. This enables you to prioritize sites based on their patient population, experience, and resources, ensuring they can deliver results on time.

We track all startup tasks—including regulatory submissions, ethics committee (EC) approvals, contracts, and essential documents—with clear ownership, deadlines, and dependencies. Interactive dashboards identify bottlenecks early, allowing study teams to proactively intervene and provide targeted support. This prevents startup delays that could impact the entire trial timeline.

Once sites are selected, we shift our focus to activation and readiness. Using standardized startup checklists within our CTMS, we ensure all critical prerequisites—such as regulatory approvals, training, investigational product (IP) supply, lab kits, and contracts—are completed before the first patient is enrolled.

We also link contract glxestones and budget elements to operational progress, providing sponsors with clear visibility into cost timelines and helping finance teams plan cash flow effectively. This approach creates a controlled, auditable pathway from site selection to "ready to enroll", reducing the risk of partially prepared sites and inconsistent processes across regions or vendors.

Monitoring achieves its highest impact when it is risk-based and data-driven. Galax CTMS supports the entire monitoring lifecycle—from planning and scheduling to reporting and follow-up.

Visit plans are dynamically linked to enrollment, risk signals, and site performance, ensuring CRAs focus their efforts where they matter most. Standardized visit report templates capture findings, protocol deviations, and action items consistently, while each action item is assigned a clear owner, deadline, and status—eliminating gaps between visits.

By integrating with Risk-Based Quality Management (RBQM) metrics, we enable targeted Source Data Verification (SDV) and central monitoring strategies, fully aligned with your quality-by-design approach.

Recruitment and retention are the lifelines of any trial. Our operations dashboards provide real-time tracking of screening, randomization, and completion rates—at the site, country, and overall study levels—compared to your planned enrollment curves.

Early deviations trigger automated alerts, allowing you to adjust outreach strategies, add sites, or reallocate resources before timelines are at risk. We also log and address operational risks—such as underperforming regions, high screen failure rates, data-entry delays, or clusters of protocol deviations—all within the same system.

This integrated, proactive approach empowers project managers to steer the trial effectively, rather than reacting to challenges after they escalate.

The Galax eTMF module ensures your essential documents are organized, accessible, and inspection-ready throughout the study—not just at the end. Every document is filed according to the TMF reference model, complete with metadata, version history, and controlled access.

Automated quality checks flag missing, expired, or inconsistent documents, allowing you to address gaps proactively—long before an inspection. Seamless links between CTMS activities and eTMF documents (such as monitoring visits and their reports) ensure full traceability across systems.

When regulators or auditors review your trial, you can confidently present a complete, up-to-date, and well-structured eTMF that clearly demonstrates how the study was conducted.

Effective oversight is critical in modern clinical trials, where multiple CROs and service providers are often involved. A robust Clinical Trial Management System (CTMS) tracks performance metrics, KPIs, and deliverables for each vendor across studies, enabling data-driven comparisons and strategic resource allocation.

At the portfolio level, the system consolidates timelines, enrollment progress, budget status, and risk assessments—providing leadership with a comprehensive, real-time view of development health. Custom executive dashboards and automated reporting eliminate the need for manual slide preparation and spreadsheet consolidation, streamlining decision-making.

With this enhanced visibility, sponsors can act swiftly and confidently, using evidence to prioritize trials, allocate funding, and implement corrective actions across their entire clinical pipeline.