Oracle Siebel Clinical Overview

Oracle Siebel Clinical Overview

Oracle Siebel Clinical is a comprehensive clinical trial management system (CTMS) specifically designed to support pharmaceutical, biotechnology, and medical device organizations in managing their clinical trials effectively. It provides a centralized platform for streamlining and automating various aspects of the clinical trial process, including study design, patient enrollment, data capture, monitoring, and regulatory compliance.

Here are some key features and functionalities of Oracle Siebel Clinical:

1. Study Design and Protocol Management: Siebel Clinical allows researchers to define study protocols and designs, including study phases, treatment arms, eligibility criteria, and study endpoints. It helps in creating and managing complex study designs with ease.
2. Patient Enrollment and Recruitment: The system facilitates patient recruitment and enrollment by maintaining a centralized database of patient profiles, eligibility criteria, and tracking enrollment progress. It helps identify potential participants based on predefined criteria and assists in managing informed consent processes.
3. Clinical Data Management: Siebel Clinical enables efficient data collection, entry, and management throughout the trial. It offers electronic data capture (EDC) capabilities, allowing for the collection of real-time data from multiple sources, such as electronic medical records (EMR) systems and clinical devices. The system ensures data integrity, quality, and regulatory compliance.
4. Investigator and Site Management: It provides functionalities to manage investigators, sites, and study site personnel. It supports activities such as site selection, qualification, initiation, monitoring, and closeout. The system helps track site performance, monitor enrollment progress, and manage regulatory compliance at the site level.
5. Study Monitoring and Oversight: Siebel Clinical allows for remote monitoring of clinical trial sites and study progress. It provides tools for managing monitoring visits, data verification, query management, and resolution. The system helps ensure protocol compliance and data accuracy throughout the trial.
6. Regulatory Compliance and Safety Reporting: The system assists in adhering to regulatory requirements and automates safety reporting processes. It supports the generation and submission of various regulatory documents, such as investigator brochures, study protocols, and adverse event reports.
7. Integration and Analytics: Siebel Clinical can integrate with other clinical systems, such as electronic data capture (EDC) systems, laboratory information management systems (LIMS), and electronic medical records (EMR) systems. It enables data exchange and seamless interoperability, facilitating comprehensive data analysis and reporting.

Overall, Oracle Siebel Clinical offers a robust platform for managing all aspects of clinical trials, from study design to data collection, monitoring, and reporting. It helps organizations streamline their processes, improve efficiency, and ensure regulatory compliance, ultimately accelerating the development and delivery of new therapies and treatments.

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