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A clinical trial management system provides the essential functionalities for tracking and managing the activities related to protocols, subjects, financials, biospecimens, etc.
Fremont, CA: Clinical trials are a massive undertaking. This comprises of massive amounts of data, hundreds of people, and many sites for investigation. The management of all these trials is a highly regulated clinical research field is challenging. It involves the incorporation of various processes, risk management, and adherence to stringent schedules. Clinical trial management systems have been designed to simplify this complicated operation and gather all the elements of a study working together harmoniously under one system.
Here are a few features of clinical trial management.
• Dashboards and Reports- Comprehensive dashboards and reports show all action items on a single page. Companies can view inventory reports, finance and costing reports, pending payments, budget reports, and invoices in this feature.
• Budgeting and Accounting- Through this feature, the company can frame the budget for each project, and expenses, track invoices, manage payments and allow integration with third-party accounting software.
• Site Monitoring- Companies can view the activity calendar and monitor various reports like recruitment, safety features, CRF reviews, and deviations from the protocol.
• Subject Recruitment- This feature shows a comparative study of actual and target numbers. Reporting is done on metrics such as screened, randomized, excluded, dropped, and integrations with EDC.
• Project Planning- This is a critical reporting feature of the clinical trial management system. Companies can use this to set up and view project milestones, assign CRA to sites, create schedules, plans, and monitor them.
• IP Inventory Management- This feature provides stock status updates, drug expiry reports, inventory receipts, and batch management.
• Document Management System (DMS) - This CTMS feature allows users to upload and share documents, folders, and grant permission to access them.
• Safety Reporting- This allows for SAE reporting and tracking, SAE data import, and EDC integration.
• Regulatory Compliance- Activity logs are maintained with checks for compliance with 21 CFR Part 11, and SOP’s are documented.
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