REDCap Cloud, based on Vanderbilt University’s REDCap electronic data capture (EDC) technology and best practices that have proven effective through more than a decade of development and deployment experience with nearly 2000 Academic Research Centers in 100 countries. REDCap Cloud enables significant efficiencies in clinical workflow and query management that scale from early-to-late-phase trials. Backed by the full security and resilience of the nPhase cloud computing platform, REDCap Cloud is offered through a software-as-a-service (SaaS) model where customers benefit from rapid and efficient EDC deployment without high upfront costs, system investment or ongoing maintenance issues.
The REDCap Cloud platform has been designed to allow our customers to deploy it as part of a validated system compliant with GCP predicate rule requirements, laws and regulations applicable to the conduct of clinical trials, and US FDA 21 CFR Part 11 pertaining to the use of electronic records and signatures.
Advanced Data Entry Options for Longitudinal Trials
Multi-Site Trial Management:
Flexible Workflow Engine
REDCap Cloud facilitates communications and compliance through customizable, automated workflows and notifications. Workflow automation alerts and notifications reduce delays and latencies and allow your organization to electronically share data with stakeholders faster, providing them with higher-quality data and the ability to take the appropriate actions.
Enhanced Randomization Functionality
Powerful Reporting Engine
Today’s clinical trials require the ability to effectively utilize data to derive insights and make informed decisions. The REDCap Cloud solution offers powerful reporting functionalities to help answer key questions through intelligent analysis and presentation of the data. Through the comprehensive range of standard reports, users can monitor study progress including query management and CRF completion statuses, while the ad hoc reporting capability allows users to create customized reports for impromptu informational needs. The dashboard presents real-time, targeted EDC metrics in intuitive, graphical display formats to aid strategic decision making by study leaders, senior management and others. Our reporting delivers highly interactive features, enabling users to drill into and interrogate data as well as download data in a variety of formats for further analysis.
CDISC and Data Extracts
Exporting ODM formatted data from the REDCap Cloud solution is a simple and hassle-free process. At any time, customers can use the self-service functionality to extract data in an ODM format, available for immediate, ad hoc review and analysis. These exports are entirely flexible and can be available on-demand, or at specified schedules, and available as a Web Service. Our customers can rest assured that their operational data and metadata, including audit trail, will be accessible using standards-based protocols, and that REDCap Cloud will be interoperable with all other components in their clinical IT eco-system that adhere to these standards. This interoperability can be directly translated to saved time and money and reduced risk in deploying and using clinical trial systems.
REDCap Cloud offers regulatory and standards compliance
US FDA 21 CFR Part 11 compliance; support for CDISC standards; robust data management; real-time data visibility; standard and user-driven reporting tools; advanced analysis capabilities; targeted SDV to support critical data points; advanced data entry options for faster data collection; and support for iPad and Android devices to deliver greater site satisfaction.