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Industry

Life Sciences

Challenge

Lack of centralized randomization infrastructure

Results

Accelerated study startup, enhanced visibility, and audit-readiness

Key Products

CTMS, eTMF, Investigator, Patient, CRO Portal

About your Customer

A leading academic research institution in the United States, this organization supports a nationwide network of clinical investigators and radiologists engaged in large-scale, multicenter studies. Known for its leadership in radiology-based clinical research, the institution coordinates research activities under strict compliance with U.S. regulatory frameworks, including FDA and NIH guidelines.

With a focus on imaging and therapeutic innovation, this institution handles a complex portfolio of studies with diverse designs and sample sizes, necessitating a digital transformation of its trial operations to support scalability and reduce operational inefficiencies.

The Challenge

Disjointed Randomization Processes: The organization relied on manual and inconsistent tools across studies, causing delays and errors in randomization tracking.
Scalability Limitations: Supporting large-scale studies with varying protocol designs became difficult with the legacy systems lacking flexibility.
Need for Real-Time Visibility: The team lacked centralized dashboards or exports for real-time oversight of subject randomization.
Integration Gaps: Manual reconciliation between trial systems led to workflow bottlenecks and increased risk of non-compliance.

The Solution

Centralized Randomization Module Deployment: Cloudbyz RTSM was implemented with support for simple, block, and stratified block randomization models adaptable to each study protocol and site.
Template-Driven Configuration: Built-in seeding logic and schema validation ensured faster setup and reuse across multiple trials, reducing startup delays.
Real-Time Monitoring and Exports: Subject allocation data could be accessed via dashboards with exportable outputs in CSV/PDF for audit-readiness.
End-to-End Integration: Seamless connectivity with CTMS, eTMF, and portals streamlined workflows across trial setup, subject management, and safety reporting.
Role-Based Access and Oversight: Role-specific controls enabled secure, transparent collaboration across sponsors, sites, and internal teams.

The Results

Accelerated Trial Setup: Study configuration timelines were significantly reduced due to reusable templates and logic-driven setup.
Improved Regulatory Readiness: Exportable reports and audit trails ensured compliance with ICH E6(R2), 21 CFR Part 11, and other regulatory standards.
Unified Oversight: All ongoing studies transitioned to a single RTSM system, improving governance and operational consistency across trials.
Enhanced Efficiency: Reduced reliance on spreadsheets and manual logs enabled clinical and IT staff to focus on high-value tasks.
Scalable Infrastructure: The RTSM now supports rapid onboarding of new protocols and investigator sites as part of the institution’s expanding research programs.

Streamlining Randomization Operations for a Leading Academic Clinical Network