This training program is designed for professionals seeking expertise in Clinical Data Management (CDM) using Oracle Clinical, a leading clinical data management system (CDMS). The course covers industry standards, regulatory requirements (ICH-GCP, FDA, CDISC), and hands-on experience in Oracle Clinical for clinical trial data processing.
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This course introduces you to the entire lifecycle of clinical data, from planning a study to locking a clean database. You will explore Oracle Clinical Navigation and the latest 5.4.0 version while learning how to generate, manage, and validate case report forms. Our training also dives into Electronic Data Capture (EDC) systems, CRF design, and regulatory guidelines like GCP and ICH. Additionally, you’ll learn how to manage study security, access controls, and perform data extractions for reporting.
Gain an overview of clinical trials, CDM roles, and global regulatory standards.
Understand Oracle Clinical's system architecture, user roles, and study setup workflow.
Learn to create studies, design CRFs, manage discrepancies, and integrate lab data.
Explore EDC methods, perform data validations, and manage AE/SAE entries efficiently.
Master query resolution workflows using both manual and automated review processes.
Generate custom reports, export data, and ensure CDISC-compliant clinical analysis.
Ensure compliance through audit trails, data integrity, and risk-based monitoring.
Integrate Oracle Clinical with RDC, MedDRA, WHO-DD, and electronic data systems.
If you want to give the trending technology experience to your esteemed emloyees, we are here to help you.
If you have three or more people in your training we will be delighted to offer you a group discount.