Professional Certificate in MedTech Clinical Trial Management
-- ViewingNowThe Professional Certificate in MedTech Clinical Trial Management is a crucial course designed to equip learners with the necessary skills to thrive in the rapidly growing MedTech industry. This program focuses on the management of clinical trials, a critical aspect of medical device development.
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โข MedTech Clinical Trial Basics: Introduction to clinical trials, MedTech industry, and regulatory frameworks
โข Study Design and Protocol Development: Designing clinical trials, creating study protocols, and endpoint selection
โข Site Selection and Management: Identifying, qualifying, and managing trial sites and investigators
โข Patient Recruitment and Retention: Strategies for patient enrollment, randomization, and retaining participants
โข Data Management: Electronic data capture, data validation, and data management plans
โข Clinical Trial Monitoring: On-site monitoring, remote monitoring, and centralized monitoring
โข MedTech Regulatory Affairs: FDA regulations, European Medical Device Regulation (MDR), and International Medical Device Regulators Forum (IMDRF)
โข Quality Management and Audits: Quality management systems, internal audits, and inspection readiness
โข Ethics and Legal Considerations: Informed consent, ethical conduct, and adverse event reporting
โข Project Management and Budgeting: Project management principles, budget development, and financial management in clinical trials
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