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Company description

Trialize is a clinical trial operating system developed by a company founded in 2022 and headquartered in Zug, Switzerland, with team members across Europe and North America. The platform integrates core clinical trial functions — including EDC, eCOA/ePRO, eConsent, TeleVisits, RTSM, Medical Coding, and Labs — into a single system designed to reduce manual effort, compress study timelines, and improve data quality. Trialize serves contract research organisations (CROs), biotechs, and pharmaceutical companies running trials across Europe and North America.

The platform is built around the premise that slow, fragmented clinical operations — protocol amendments taking months to implement, researchers spending the majority of their time on data wrangling, and sponsors lacking real-time visibility — can be addressed through automation and integrated workflows. Trialize reports that pilot studies have shown approximately 50% faster study start-up, an average saving of $317,000 per Phase II trial, and database lock achieved around two months earlier than conventional approaches.

Key Modules and Capabilities

• Study Wizard: Accepts protocol uploads and automatically generates validated database structures, case report forms (CRFs), edit checks, and validation rules, reducing database build time by approximately 50%.
• Analytics: Provides a real-time dashboard covering enrollment, risk indicators, and key performance indicators across studies, with predictive analytics to support go/no-go decisions.
• Automate: Handles repetitive operational tasks — including query management, alerts, medical coding, and supply runs — through a rules-based automation engine that operates without ongoing manual input.
• Data Hub: Centralises data management across studies, supporting integration and data flow within the broader platform.
• The full platform comprises a ten-module suite, with the four listed above described as the primary modules powering study operations.

AI and Digital Capabilities

• AI is used to transform uploaded protocol documents into production-ready CRFs with automated edit checks.
• Digital biomarkers, risk-based monitoring (RBM), and predictive models are available and can be activated on a per-study basis.
• Predictive risk analytics are available to support proactive decision-making during trial execution.
• Regulatory compliance automation is included as part of the platform's capabilities.

Segment-Specific Features

• CROs: The platform targets reduction of rework and change-order delays, with reported EBITDA improvement of approximately 9%, real-time risk monitoring, and faster study start-up to support sponsor retention and operational margins.
• Biotechs: Automated query resolution, predictive risk analytics, and regulatory compliance automation are highlighted, with an eight-week improvement in data-lock timelines cited as a key outcome.
• Pharma: Enterprise features include multi-study dashboards, an advanced analytics suite, enterprise integrations, and portfolio-wide visibility, with a reported 5–10% cost reduction across global trials.

Company Background and Approach

• Founded in 2022 by individuals with backgrounds in clinical operations at both early-stage biotechs and large pharmaceutical organisations.
• The first pilot, conducted in 2023 with a Series B biotech, demonstrated a 50% reduction in study build time.
• By 2024, the platform was in use across CROs, biotechs, and pharma companies in Europe and North America.
• The company's stated values include maintaining data quality and compliance alongside speed, full auditability and traceability of data, and a focus on building features that address specific operational problems rather than technology for its own sake.
• Headquarters are located at Industriestrasse 24, 6300 Zug, Switzerland.

Trialize positions itself as an end-to-end operational platform for clinical trials, combining integrated modules, workflow automation, and real-time analytics into a system intended to reduce the time and cost burden of running studies from start-up through database lock.

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Software attributed to Trialize

• Clinical Trial Operating SystemView
• Modules SuiteView
• AI OpsView

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