Clinical Trial Operations

Oracle Clinical Trial Operations is a suite of cloud-based applications designed for sponsors and contract research organizations (CROs) involved in managing clinical trials. The suite covers portfolio planning, study startup, electronic trial master file (eTMF) management, and clinical trial management, all delivered on Oracle Cloud Infrastructure (OCI). The solutions are intended to support regulatory compliance, data integrity, and operational oversight across the clinical development lifecycle.

The suite includes several distinct products: ClearTrial (for sponsors and CROs), Site Select, Site Feasibility, Site Activate, Patient Recruitment, eTMF Cloud Service, and CTMS. These tools are designed to integrate with one another as well as with external systems such as electronic data capture (EDC) platforms and electronic health records (EHRs).

Portfolio Planning

• Oracle Life Sciences ClearTrial for sponsors supports clinical trial planning, budgeting, and management through cloud-based automation, using activity-based costing, benchmarking, and advanced analytics.
• Centralizes study data and connects workflows across enterprise systems to provide real-time operational insights and support regulatory compliance.
• ClearTrial for CROs supports proposal development, resource planning, and project delivery with smart budgeting tools and automation.
• Connects core study data with project management and financial systems to enable near real-time data sharing and coordination with sponsors.
• Supports scenario modeling and vendor comparisons to facilitate data-driven decisions.

Study Startup

• Oracle Life Sciences Site Select identifies, evaluates, and prioritizes clinical trial sites by integrating near real-time performance metrics, investigator databases, and feasibility data into a single platform.
• Connects to external data sources and existing clinical trial management systems to support consistent decision-making and regulatory readiness.
• Oracle Life Sciences Site Feasibility centralizes site survey data, investigator profiles, and performance metrics to streamline feasibility workflows and support informed site selection.
• Integrates with trial management and site selection systems for coordinated decision-making and secure data sharing.
• Oracle Life Sciences Site Activate centralizes document workflows, regulatory packet management, and communications on a unified cloud-based platform.
• Automates and tracks critical milestones, supports collaboration among sponsors, sites, and CROs, and maintains audit-ready transparency through submission, review, and approval cycles.
• Oracle Life Sciences Patient Recruitment coordinates, tracks, and manages clinical trial recruitment across multiple sites using automated workflows and centralized dashboards.
• Integrates with site management systems and EHRs to support candidate identification, referral management, and enrollment alignment with study objectives.

Trial Master File Management

• Oracle Life Sciences eTMF Cloud Service organizes, manages, and provides access to essential trial documentation on a secure, cloud-based platform.
• Automates document workflows and centralizes regulatory content to support audit readiness and collaboration across teams and stakeholders.
• Integrates with clinical trial management and site systems to enable efficient data exchange and consistent document tracking throughout the trial lifecycle.

Clinical Trial Management

• Oracle Life Sciences CTMS provides centralized tracking of study activities, site performance, and regulatory documentation across the trial lifecycle.
• Configurable workflows and advanced automation unify data management and support timely collaboration among sponsors, CROs, and sites.
• Covers study planning, site and investigator management, operational tracking, document management, payments, and risk assessment.
• Integrates with EDC and eTMF systems to support data integrity, compliance, and consistent trial execution across research portfolios.

All solutions in the Oracle Clinical Trial Operations suite are delivered on Oracle Cloud Infrastructure and are designed to integrate with each other as well as with external enterprise and clinical systems. The suite is intended to support regulatory compliance, inspection readiness, and scalable operations for life sciences organizations managing clinical research programs.