REDCap Cloud EDC

REDCap Cloud EDC

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.

REDCap Cloud EDC

Regulatory Compliance

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.

REDCap Cloud Data Entry

Advanced Data Entry Options for Longitudinal Trials

Project Templates – fast and easy study build of CRFs with configured fields ready for edit

Easily capture ad hoc and repeating data (AEs, Medications, office visits, etc.)

Faster study design – a simple point and click user interface

Dynamic data displays for enhanced site experience

Faster data entry by site; particularly significant for early phase studies

REDCap Cloud Data Source

Multi-Site Trial Management:

Enhanced capabilities designed for multisite trials to manage site activities, visit management

Ability to compare site performance across protocols or compare protocols across sites, based on user defined milestones and benchmarks, provides greater visibility into site activities

REDCap Cloud Security

Pre-Screening Module

Enables confirmation that eligibility criteria are met

Designates individual data at field level on forms for source verification

Selects subjects, critical forms, and data items in user interface

Facilitates risk-based monitoring to increase efficiency

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REDCap Cloud Workflow

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.

REDCap Cloud Data

Enhanced Randomization Functionality

Access to multiple randomization techniques

Flexible and customizable based on demands of study

REDCap Cloud Reporting

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.


REDCap Cloud Data Extraction

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 EDC

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.

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