Features

Features that deliver real benefits

Whether you use our DF Cloud hosting service or install our software on you own server, our internet apps have the features you need to set up, customize and manage any clinical research project.

  • Electronic Data Capture

    Key Features Description DF Cloud Self Hosted
    Detailed user permissions

    Permissions defined in study roles determine what each user can see and do, from creating, modifying and viewing data values to importing and exporting data and PDFs, running study reports, and more.

    Intuitive user interface

    Organized like a set of patient binders with screens that match paper CRFs makes iDataFax easy to learn and use.

    Quick status checks

    Status icons help sites identify patients, visits and screens where data entry is not yet complete.

    Data entry help

    Drop down lists, lookup tables, field level color coding, range checks, and help messages all help to ensure accurate data entry.

    Real-time edit checks

    Use standard edit checks or create custom edit checks to: detect problems, display warnings, request corrections, create queries, compute derived values, trigger email messages, and more.

    Respond to data queries

    In iDataFax Query View sites can see all outstanding queries and jump to the corresponding data screen where color coding and status icons help sites identify and respond to each query.

    Add reasons for data values

    In iDataFax users can attach a reason to any data field to explain missing or atypical values and thereby minimizing queries from data managers.

    Spreadsheet data views

    Using iDataFax List View sites can review a spreadsheet showing the same data fields for all patients and click any value to jump to that patient’s data screen.

    UNICODE

    Build studies in any language, or allow sites to switch between data screens in different languages and enter text and respond to queries in their own language.

    FDA – 21 CFR Part 11

    iDataFax is compliant with all regulatory
    requirements including e-signatures, audit
    trails, and rules for password complexity, aging and
    notification.

    Secure Internet transmission

    All data and PDF transmissions over the
    internet use 256 bit SSL encryption.

    Windows, Macs, Linux and Solaris

    iDataFax is available for all popular computer systems and installs in seconds; providing enhanced security, performance and functionality compared to browser based EDC systems.

  • Electronic Paper Capture

    Key Features Description DF Cloud Self Hosted
    EDC & Paper in the same study database

    We provide a true hybrid system capable of collecting, processing and storing both data and images of paper documents.

    Intelligent Character Recognition (ICR)

    Our ICR software reads handwritten numbers, dates, check boxes and visual analog scales (VAS). Accuracy depends on the clarity of handwriting, but expect at least 90% of data fields to be read correctly from most study sites.

    An alternative to EDC

    As an alternative to EDC, sites can send completed CRFs to the study server (by fax or over the internet using DF Send) where the CRFs are read by intelligent character recognition (ICR) to create an initial data record for split-screen review, correction and entry by data managers.

    Secure Internet transmission

    PDF transmissions meet regulatory requirements for authentication and tracking and use 256 bit SSL encryption.

    Capture paper records

    CRFs, study worksheets, source documents, etc. can be captured, linked to patient data records, and stored in the study database.

    Capture PDFs during EDC

    Sites using EDC can attach scanned pages to any patient record to allow reviewers to verify that data was entered correctly or to include information not captured by EDC.

    Capture PDFs without EDC

    Sites that don't use iDataFax for EDC can use DF Send to transmit PDFs to the study server for central review and processing by data managers.

  • Data Management

    Key Features Description DF Cloud Self Hosted
    Intuitive user interface

    The same intuitive iDataFax user interface, used by the sites for data entry, is used by data managers for data reviews, coding tasks, importing lab data, exporting SAS data sets, etc.

    Create queries

    Queries can be created manually or by edit checks.

    Resolve queries

    Queries can be resolved automatically when the originating problem is solved, or manually by a data manager.

    Approve reasons and replies

    Reasons added by the sites to explain data values, and replies to queries, can be reviewed and approved, or a new query can be created.

    Data exports

    Data can be exported to flat ASCII files, or to SAS data sets.

    Data imports

    Data can be imported from labs and other sources using a simple field mapping dialog.

    Coding

    Auto and manual coding can be performed for drugs, adverse events, etc. using configurable lookup tables with extensive search features.

    Standard reports

    Standard reports for: study, site and patient tracking, query management, audit trails, work flow and descriptive statistics can be applied to any study.

    Study tasks

    Study managers can create tasks, including instructions and workflow steps, for any user or study role. Tasks allow users to quickly assemble all data records meeting the specified task criteria.

    Work flow management

    Data records can be tracked across work flow levels until all tasks are completed.

    Batch edit checks

    Edit checks can be run in batch mode as well as in real-time.

  • Study Setup

    Key Features Description DF Cloud Self Hosted
    Training

    One internet training session plus our
    extensive documentation is typically all a
    study manager needs to become
    proficient at study setup.

    Generic edit checks

    Most of the edit checks needed in clinical
    research are included in a set of generic
    edit checks that can be used without
    programming, or copied and modified to
    meet your specific requirements.

    Data screens match CRFs

    Data screens are created using a blank
    copy of the study CRFs and thus match
    the CRFs exactly making them perfect
    for hybrid studies in which some sites
    use EDC while others transmit completed
    CRFs.

    Test environments

    Before making major changes to a
    production database, use DF Setup to
    clone the study so that changes can be
    tested in a separate database. Then
    when testing is complete publish your
    changes to the production database.

    Mid-study changes

    Modifying a data screen to add, delete or
    reorder fields, and other setup changes,
    are just as quick and easy as the original
    study setup.

    Fast and efficient

    Field definitions, edit checks, visit maps,
    etc. can all be imported from another
    study or a project library.

    Simple configuration dialogs

    Each step in the setup process is
    covered in a series of simple dialogs and
    completely explained in the build-in user
    guide.

    Intuitive user interface

    DF Setup provides a simple point and
    click interface enabling study managers
    to configure new studies without
    programming.

  • Other

    Key Features Description DF Cloud Self Hosted
    Server login accounts

    Creation and management of login accounts on the study server for programmers and system administrators.

    Per server pricing

    Use our software for any number of studies for a single annual license fee.

    Software as a service

    Server administration, security, backups, disaster recovery, managed by skilled professionals in our state of the art data center.

    Per study pricing

    Cost effective pricing, tailored to your needs for individual studies, large or small.