OnlineCRF

2 reviews

OnlineCRF is a cloud-based Electronic Data Capture system designed to streamline data collection and management in clinical trials, post-marketing studies, and registries. Tailored to meet the specific requirements of each study protocol, OnlineCRF offers a user-friendly interface that facilitates efficient data entry and real-time monitoring. The system is fully compliant with industry standards such as FDA 21 CFR Part 11, GCDMP, and GDPR, ensuring data integrity and regulatory adherence. Key Features and Functionality: - Data Pre-Validation: Ensures that only valid data within specified ranges are saved, reducing errors during data entry. - AE/SAE Reporting: Facilitates adverse event reporting with automated notifications to the pharmacovigilance department. - Query Generation: Allows Clinical Research Associates to generate and resolve queries for questionable data, enhancing data accuracy. - Randomization: Supports various randomization methods configurable before data collection begins. - Audit Trail: Maintains a comprehensive record of all data modifications, including reasons and user details, ensuring transparency. - Digital Signature: Enables principal investigators to electronically sign completed and verified Case Report Forms . - Real-Time Monitoring: Provides dashboards for tracking study progress and investigator activity, allowing for immediate corrective actions if needed. - Multilevel Backup: Implements data backups every two hours, storing multiple copies on physically separated servers to ensure data security. Primary Value and User Solutions: OnlineCRF addresses the complexities of clinical data management by offering a comprehensive, secure, and compliant platform that enhances data quality and operational efficiency. Its intuitive design reduces training time, allowing research teams to focus on their core activities. The system's flexibility accommodates various study designs, including randomized and non-randomized trials, as well as single or multi-country studies. By providing real-time monitoring and robust data validation, OnlineCRF ensures that clinical trials remain on track, facilitating faster and more reliable research outcomes.