How a Genetic Testing Company Gained RealTime Budget Visibility

Industry

Life Sciences

Challenge

Managing complex, multi-site Phase 3 trials with decentralized teams and legacy systems led to operational inefficiencies and compliance risks.

Results

Achieved streamlined trial oversight, enhanced document compliance, and faster site activation across global studies.

Key Products

CTMS, CTBM

An image of a person working in a pharmaceutical company overseeing pharmacovigilance activities in the EU

About your Customer

A mid-sized U.S.-based biotechnology company dedicated to developing treatments for rare neurological and neurobehavioral disorders faced growing complexity in managing its clinical trials. With a pipeline focused on addressing unmet needs in conditions such as sleep/wake disorders and rare epilepsies, the sponsor was rapidly expanding its clinical operations. However, fragmented trial oversight, siloed documentation, and a heavy reliance on CROs for updates created significant bottlenecks. These issues limited visibility into trial progress and financials, delayed critical decisions, and posed challenges in maintaining inspection readiness.

To regain control and improve efficiency, the sponsor implemented an integrated clinical and budget management platform. By centralizing operational workflows and financial tracking in a single system, they enabled real-time collaboration with CROs, automated essential processes, and gained immediate access to trial metrics and budget insights.

The Challenge

As the company expanded its clinical development programs, it faced several operational challenges:

Disparate Systems: Utilization of multiple, non-integrated systems for trial management and budget tracking led to data silos and inefficiencies.
Manual Processes: Reliance on spreadsheets and manual data entry increased the risk of errors and delayed decision-making.
Limited Visibility: Lack of real-time insights into trial progress and budget status hindered proactive management.
Compliance Risks: Inadequate tracking mechanisms posed challenges in meeting regulatory compliance and audit readiness.

The Solution

To address these challenges, the company implemented Cloudbyz's integrated CTMS and CTBM solutions:

Centralized Trial Management: The CTMS provided a unified platform to manage study protocols, site information, subject enrollment, and both central and on-site monitoring activities. Automated scheduling, trip reports, and CRA performance tracking enhanced visibility and compliance across trial phases.
Automated Budget Tracking: CTBM enabled real-time budget planning, tracking, and forecasting. The system supported site-level financial management, reducing manual workloads and increasing financial accuracy.
Feasibility Analysis & Study Start-Up: Built-in tools for feasibility surveys allowed the team to evaluate site readiness and performance early in the study lifecycle. This accelerated study start-up and improved site selection accuracy.
Enhanced Reporting: Customizable dashboards and real-time reports offered immediate access to key trial and financial metrics, enabling faster, data-driven decision-making.
Compliance Support: Comprehensive audit trails, document workflows, and milestone tracking ensured regulatory alignment and improved inspection readiness across all studies.

The Results

The implementation of Cloudbyz's solutions led to significant improvements:

Operational Efficiency: Streamlined processes reduced manual workloads, allowing teams to focus on strategic activities.
Improved Visibility: Real-time access to trial and budget data enabled proactive management and timely interventions.
Financial Accuracy: Automated budget tracking minimized errors and enhanced financial planning capabilities.
Regulatory Compliance: Robust tracking and documentation features strengthened compliance posture and audit preparedness.

By leveraging Cloudbyz's integrated CTMS and CTBM solutions, the company transformed its clinical trial operations, achieving greater efficiency, financial control, and compliance readiness.

Transforming Clinical Trial Management: Why a Top U.S. Biotech Chose Cloudbyz to Enhance Oversight and Efficiency