Clinical Trial Operating System

Trialize is a Clinical Trial Operating System designed for CROs, biotechs, and pharmaceutical companies. It integrates EDC, eCOA/ePRO, eConsent, TeleVisits, RTSM, Medical Coding, and Labs into a single platform, with the goal of reducing operational bottlenecks, compressing study timelines, and improving data quality across clinical trial operations.

The platform targets clinical operations and data management teams looking to accelerate study start-up, automate repetitive workflows, and achieve earlier database lock. According to Trialize, pilot studies recorded a median saving of $317,000 per Phase II trial, approximately 50% faster study start-up, and database lock approximately 60 days earlier than conventional approaches.

Core Workflow

• Upload and Build: Users upload a study protocol and the system generates validated database structures, case report forms (CRFs), edit checks, and validation rules automatically using AI.
• Automate: Queries, alerts, medical coding, and supply runs are handled by an automation engine based on rules configured once by the user, reducing manual repetitive work.
• See and Decide: A live dashboard provides real-time visibility into enrollment, risk indicators, and key performance indicators across all studies, with predictive analytics to support go/no-go decisions.

Key Modules

• Study Wizard: Converts an uploaded protocol into a validated database with CRFs, edit checks, and validation rules generated in minutes.
• Analytics: Provides study-level and portfolio-level reporting and predictive risk analytics.
• Automate: Manages automated query resolution, alerts, coding, and supply chain actions.
• Data Hub: Centralises data management across studies.
• The platform offers a full suite of ten modules in total.

Capabilities by User Segment

• CROs: Supports 50% faster database build, eliminates change-order delays, and provides real-time risk monitoring. Reported benefit includes a 9% EBITDA improvement through reduced rework and faster study start-up.
• Biotechs: Offers automated query resolution, predictive risk analytics, and regulatory compliance automation, targeting an 8-week faster data lock to extend runway and accelerate time to market.
• Pharma: Provides multi-study dashboards, an advanced analytics suite, and enterprise integrations for portfolio-wide visibility and global standardisation, with a reported 5–10% cost reduction.

Platform Features

• Integrated modules covering EDC, eCOA/ePRO, eConsent, TeleVisits, RTSM, Medical Coding, and Labs.
• AI-driven protocol-to-database transformation producing production-ready CRFs.
• Automated edit checks and validation rules generated at study build.
• Real-time enrollment tracking and risk monitoring across multiple studies.
• Predictive analytics for proactive risk identification.
• Regulatory compliance automation.
• Enterprise integrations for large-scale pharma deployments.

Trialize supports CROs, biotech sponsors, and enterprise pharma organisations. The platform is positioned as a unified operating system rather than a collection of point solutions, with enterprise integration capabilities and multi-study portfolio management available for larger organisations.