Our data management solutions are powered by DFdiscover (previously known as DataFax), our reliable, flexible, mature, and scalable database management software system.
DFdiscover is a full featured CDMS that is very easy to learn and use. The feature set has been expanded and refined over 20+ years of use in clinical trials by organizations around the world. Every feature has a practical clinical trials need at its base.
Data is presented in a familiar subject binder interface with data entry screens that exactly match study CRFs, or optionally flow to meet the responsive needs of mobile devices and smaller screens. Users with appropriate permissions can query data values, resolve queries and provide reasons to support data values and missing responses. Lookup tables, drop-down lists, sliders, range and edit checks, field skipping, help messages, etc are all built-in. DFdiscover understands subject scheduling and tracking, for even the most complex trial designs, and automatically tracks missing CRFs and overdue visits.
Features and Benefits
Hybrid data management: paper, EDC, or both
Data collection by paper and EDC interchangeably. Build once, then collect data in ways that fit your needs. Includes tools for study database definition, rapid data collection, verification and cleaning, subject scheduling and compliance tracking, standard data reporting, and exports to Excel, SAS, SQL, and others.
License as software or as a complete study solution
Partner with DF/Net to setup, manage, and analyze your clinical trials, or work completely independently with our training and support.
Self- or cloud-hosted flexible licensing model
You may want more control over the security and availability of your data. Perhaps your institution has its own regulations. Or there are governmental regulations on the distribution of data across countries or continents. Or maybe you just want to actually know where your data is. It's up to you, it's your data.
Or perhaps you just want to run DFdiscover as a service. You don't want to own any hardware, or worry about disaster recovery, backups, upgrades, or other IT needs. You just want your data available to you, your monitors, and your sites.
You can make the choice. Unlike other systems, DFdiscover is available for installation within your controlled premises, or we can host it in our secure cloud environment.
You can license it by the study or by the enterprise for use across up to 999 studies, making it cost-efficient and scalable for all sizes of installations.
Paper, EDC, or Tablet
Best fit for your trial may be traditional paper CRFs or paperless EDC. Mix and match for some sites or for even certain types of forms, DFdiscover adapts to your needs.
EDC has many advantages.
DFdiscover's hybrid approach works seamlessly for both paper and EDC studies. A common background can become the same paper CRF, or the corresponding EDC screen. For studies that have no paper CRF at all, data entry screens are built to be responsive, altering layout to make the best use of available screen space.
The EDC screen in our DFexplore desktop application looks identical to the CRF, providing a 1:1 relationship between the data and the CRF. EDC screens can be designed to match the clinic flow and source documents, making monitoring more efficient with less need to “hunt and peck” to find the data.
DFcollect online/offline solutions open the door to tablet based remote data collection without custom app provisioning. Imagine one study definition that provides consistent data views at the central project office, in the monitor’s hands, and in remote locations - this is the promise of DFdiscover, enabled by DFcollect. Data entry, query review and supplementary document management are all possible with DFcollect’s intuitive tablet interface. DFcollect works online, and is equally capable offline, making collected data immediately available for central review after connectivity is restored.
DFweb leverages your existing browser and brings the power of DFdiscover to the desktop, without installing an application. eCRFs are presented in a familiar subject binder view. Designed for fast/accurate data entry, DFweb includes tools to streamline data collection, query creation, and review. DFweb presents the same data that is managed at the central site, adding the power and simplicity of a web browser interface. Like DFexplore and DFcollect, no customization is needed - simply enable and deploy, using the same study definition.
Commitment to Standards
Compliant with all FDA 21 CFR Part 11 regulations, our software is developed, maintained, and supported by a company whose quality processes are ISO 9001:2015 certified.
Designed for studies subject to regulatory review, DFdiscover includes: electronic signatures, password aging, reuse, complexity and lockout rules, fine-grained user permissions, audit trails, and secure SSL encryption of all data and document transmissions over the internet.
Upload CRFs, study documents, images, and videos
Keep the connection between the data and its source. DFdiscover allows you to import supplementary documents and attach them to data records. The documents can include electronic worksheets, PDFs, images and DICOM videos. See both the EDC screen and the images side-by-side, a useful feature for safety review and remote adjudication. Running a vaccine trial? Make your reactogenicity form take on real meaning by attaching an image of the injection site.
Application programming interface (API)
Build your own interface, or connect to other systems to push or pull data and study resources. To simplify the creation of your own interface, or to connect with external systems for push or pull of data and study resources, an application programming interface (API) is available in DFdiscover. Our mobile and browser-based data collection tools are also built upon this same API.
Advanced quality control and subject tracking
Edit checks, subject tracking, and quality control features are easily deployed by data managers without programming experience.
SDV and RBM
Easy to deploy support for Source data verification (SDV) and risk-based monitoring (RBM) allows those processes to be more efficient, saving valuable monitor time.