11/2/2023 0 Comments Inform edc medidata raveAccessibility and AvailabilityĮDC systems provide faster and broader access to data. An EDC system will automatically store these audit trails, which can easily be viewed. Having traceability of any changes to data or study design is also key. Automated checks can save sponsors and CROs a considerable amount of time, which during early-stage trials is of utmost importance. Before electronic data capture, these checks were done manually and, as such, subject to human error. An EDC system will also run automated data quality checks and flag any errors or data anomalies. Examples include basic checks like dates being entered in the right format or the age of a patient being within acceptable range for the study, or more complex checks like if a patient is female, then a pregnancy test might be warranted before participating in the study. EDC Validation and QualityĪn EDC system will have standard built-in checks. When data was collected manually and on paper, it could be lost and destroyed without any backup or recovery options. Benefits of Using EDC Secure Clinical Trial Data and ControlĬollecting and managing clinical trial data in an electronic system, which is usually cloud-based, ensures secure access and control from anywhere. Looking ahead to 2022, 90% of Phase I clinical trials are expected to use only EDC applications 1. From 2019-2020, 81% of Phase I clinical trials were using only EDC. Trials using paper and hybrid data collection tools are in massive decline and this decline is expected to continue. Ultimately, an EDC system provides the central and secure place for validated, locked data ready for analysis at the close of the clinical trial. Data managers and clinical research associates (CRAs) can then review and query this data, with queries automatically flagged to the sites. EDC, first used in the 80s and 90s, replaces the traditional, paper-based data collection approach to streamlining and centralizing data collection, which drastically improves drug development timelines and costs.ĮDC systems validate data entered by clinical trial sites to ensure accuracy. What Is EDC?ĮDC is a system for collecting, managing, and cleaning site-, patient-, and lab-reported data in an electronic format for use in clinical trials. While these trials face considerable challenges in their early stages, a robust and intuitive solution can help to mitigate these obstacles. Leveraging tools like EDC can set the pace and success of the entire study. In the first blog in this series, we looked at the increased complexity of Phase I clinical trials and how technology-specifically electronic data capture (EDC)-can support sponsors and partners in the conduct of these important studies. Katrina has grown and cultivated global partnerships at Medidata for over a decade, expanding the reach of the company’s transformative platform for clinical development, commercial, and real-world data. This blog was authored by Katrina Weigold, Vice President of Global Partners at Medidata. ![]() ![]() Proactive risk mitigation for research data quality issues to help prevent trial delays.Įmpowering a risk-based approach to source data verification by focusing on critical data.Ī cloud-based remote site access and monitoring solution. Quickly and accurately develop investigator grant budgets.Ī dynamic digital solution for risk assessment, monitoring, and mitigation.Ī powerful data & risk surveillance tool to improve data integrity & reduce trial risk. Unify your clinical research study data and financial management in one platform. Manage electronic trial master file content while maintaining readiness & compliance. Improve speed and efficiency for the oversight of studies with Rave CTMS (Clinical Trial Management System). Seamlessly generate, distribute, & manage clinical study files at the end of a study.ĭrive faster timelines across the trial lifecycle with centralized data & analytics.Ī streamlined, single digital endpoint adjudication system. RTSM (Randomization and Trial Supply Management)Įliminate double data entry and change orders for randomization and trial supply management.Īutomate collection, transmission and tracking of adverse event data. ![]() Simplify complex data investigation and cleaning across many data sources. Gain visibility and full control over your imaging data while simplifying processes for sites, sponsors, and core labs. The evolution in automated medical coding for Rave EDC. Eliminate complex, manual processes & achieve higher quality data for faster insights.Ĭapture and manage your patient, site and lab in the most advanced, robust and secure electronic data capture system.Įquip your clinical trial study with fast, accurate medical coding.
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