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Industry

Life Sciences

Challenge

A leading biotech innovator specializing in early cancer detection faced growing complexity in managing multinational clinical trials. The company struggled with fragmented budgeting, manual site payment processes, and siloed EDC data across two systems — leading to operational inefficiencies and compliance risks.

Results

The company achieved centralized visibility, harmonized budgeting, and streamlined site payments across its European clinical sites. Real-time collaboration between clinical operations and finance improved accuracy and efficiency, enabling the biotech to confidently scale its trials while maintaining regulatory readiness.

Key Products

CTMS, CTBM

Leading CRO Transformed Clinical Trial Operations-3

About your Customer

The customer is a clinical-stage biotech company based in Europe, focused on pioneering early cancer detection through liquid biopsy technology. Their innovative work addresses unmet needs in colorectal cancer screening with a vision to expand into additional cancer indications. Operating under EMA, GDPR, and IVDR regulations, they are currently executing multicenter clinical trials across multiple European countries, with plans for FDA alignment as they expand globally. The biotech is building a foundation for commercial scale while maintaining stringent focus on data quality, compliance, and financial integrity.

Their teams include cross-functional stakeholders from clinical operations, regulatory affairs, finance, and biomarker research, all collaborating to bring transformative diagnostics to market.

The Challenge

Fragmented budgeting and payment processes: Clinical budgeting was previously managed via Excel-based tracking, with manual updates creating risk of version errors and lack of real-time visibility.
Multi-country complexity: Trials spanning several EU countries led to inconsistent site budgeting practices, currency handling, and challenges in tracking country-specific requirements.
Disconnected EDC platforms: The company used Castor EDC and Medidata Rave EDC, resulting in data silos and redundant data reconciliation between systems.
Compliance risk: Manual payment processes and document tracking raised concerns about GDPR compliance, audit readiness, and financial transparency.
Cross-team collaboration gaps: Lack of integration between clinical operations and finance hindered seamless reporting and impacted forecasting accuracy.

The Solution

Centralized clinical trial management: Cloudbyz CTMS provided a single source of truth for study tracking, site management, and milestone planning across all active trials.
Streamlined budgeting: Cloudbyz CTBM enabled the creation of harmonized budget templates across all sites, factoring in country-specific requirements, currency variations, and site fee structures — replacing disparate Excel sheets.
Integrated site payments: Sites now submit invoices via the Cloudbyz Site Portal, with automated workflows ensuring real-time tracking of payments and faster approvals.
EDC integration: Seamless integration with both Castor EDC and Medidata Rave EDC allows clinical and financial data to flow smoothly, eliminating silos and enabling end-to-end visibility.
Regulatory alignment: Cloudbyz solutions fully support GDPR and EMA IVDR compliance, with robust audit trails and real-time reporting to meet both European and US regulatory expectations.
Cross-functional dashboards: Cloudbyz enabled custom dashboards accessible by clinical, finance, and executive teams, fostering a collaborative, data-driven culture.

The Results

Harmonized budgeting: The company now operates with standardized site budgets across Europe, supporting greater accuracy and predictability in trial costs.
Accelerated payments: Automated workflows and portal-based invoicing have reduced administrative delays and improved site satisfaction.
Improved compliance: Real-time tracking and audit trails provide the organization with confidence in regulatory inspections and financial audits.
Operational efficiency: By integrating CTMS with multiple EDC platforms, the biotech has significantly reduced the manual effort required for data reconciliation — freeing resources for higher-value clinical tasks.
Scalability: The biotech is now equipped with a scalable, cloud-based solution to support its pipeline expansion and commercial readiness.

Driving Clinical and Financial Excellence: How a Leading Biotech Streamlined Trial Operations with Cloudbyz CTMS & CTBM