Features

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Features
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Information Management

  • Data are always kept inside a central database. All project data and all files are kept at a single location. As soon as new project data are available, they are entered directly into the system and so they are immediately available to everyone for viewing or reporting. A single central storage will make sure that no duplicates of data records or outdated data copies exist. It also ensures a high degree of safety, since access to the storage is always password-controlled using data encryption and allowing easy replication of the database to a physically remote location. This guarantees that even in case of a total server facility loss no data are affected.
  • The data structure is freely configurable without having to stop or update the system.
    You can set up each of your studies individually at any time. You can choose to track only a single data field per subject, or to capture really all the data - every document and every visit with all related data. Just add, remove fields or entire lists with a click of your mouse, while everyone else is able to continue working.
  • High degree of availability
    Usually, data are transferred from the site by a monitor to the management and evaluated on the sponsor's or CRO's side. Since EasyClin® allows direct storage and retrieval of project data from its central database, all the manual data transfers and evaluations are no longer required. All the data stored can be browsed and used for reporting instantly.
  • All the data are stored in a specialized data history.  
    Anytime a user removes a data entry, it disappears from the display – but is still kept inside the data history. This storage may be used to precisely reconstruct the whole database for any point in time. This makes it even possible to re-run a report: You can go backward in time, re-run reports and so follow the development of your project.
  • System-wide audit trail for every minor change in your data  
    Since EasyClin's data history is not even modifiable by an administrator, it is an ideal tool to create audit trails. Every single change in any data record, in conjunction with the originating user account, as well as a date/time stamp is always memorized in the data history. This feature makes it possible to reconstruct any change in your data and create a detailed output of every change.
  • Data may be exported to a variety of formats including XML, HTML, PDF or Excel.
    No matter whether you want to process the tracked data with some other software, create your own reporting or simply need some data right away as an Excel sheet, EasyClin® makes it possible to export your data to Excel, run reporting which may create many output formats, such as plain text, PDF, Postscript, Excel, HTML or to export the raw data to XML.
  • The data may be archived in a simple set of HTML files which are viewable without EasyClin® using any web browser.
    Once the project is finished, all project data must be stored in a way that is easily accessible, without having a running EasyClin® installation at hand. For example, the data should be used for an electronic submission dossier. This is accomplished by archiving all lists, data elements, the reporting and files in HTML documents. These may be simply written on a CD, DVD, USB stick, hard disk or any other kind of storage medium and accessed by just opening the HTML files with a web browser.
  • File management
    Files can be managed in almost the same way as any other data record. Instead of entering a new value, the user selects a file from his computer to upload, or simply clicks the “Download” button to receive a copy of the stored file. EasyClin's locking mechanism guarantees exclusive access to a file. This means you can be sure no one else overwrites the file in the central database as long as you are working on it. In conjunction with the data history it is possible to re-construct any previously overwritten or deleted copy of a document. This feature makes EasyClin® a comfortable solution for easy management of documents online.

Interface

  • Universal access due to web-based interface.
    EasyClin® is directly usable from practically any computer without any additional software installation, simply because EasyClin® only requires a JavaScript enabled web browser; this exists on practically all new computers, no matter which operating system is used. You can access your data via EasyClin® even from computers you have never used before, as long as they are connected to the internet. This is especially valuable when working from a study site, a home office or a hotel. This feature has also proved to be extremely helpful in case a computer collapsed. From a personal computer you just log into EasyClin® without any further delay.

  • The interface is based on AJAX, making the application look like a regular application instead of a passive webpage. 
    EasyClin® makes use of AJAX, a new technology for web-based applications, which allows you to recognize changes to your data on-screen without having to reload the webpage or click a “refresh” button. Data changes or data structure modifications directly appear on-screen as soon as changes are made to the database. This makes the handling of the application much simpler, faster and also safer, since the software behaves the way the user is accustomed to; this again reduces training requirements.

  • Data transmission is always encrypted.
    EasyClin® makes use of the built-in encryption in web browsers. This allows high-grade encryption to be used, even without any further software installation. This is the same encryption mechanism used for online banking and other sensitive applications. It provides a high degree of safety, especially compared to the non-encrypted usage of emails.

  • True multi-user capabilities
    Many users can access the database at the same time and view all the data to which they have read access. When writing however, users first have to “lock” the area they would like to modify. As soon as this section has been locked, it is no longer writeable by other users who have to wait for the first user to finish the work and release the lock. This concept ensures that those users are not accidentally writing into the same data field and it is also helpful for file management. As long as a user keeps a file locked he can work on it exclusively and can be sure, when uploading the new version of the file, no data have been altered after the lock was granted.

  • Unified handling of all data guarantees minimum training requirements.
    In general, all sections of the database – list of centres, list of subjects and the like – use the same layout and on-screen handling. That means that once users know how to add a new subject, they also know how to add all other items, like centres, documents and the like. Since this is applicable not only to adding items, but also to modification, removal, re-ordering etc., training requirements have shown to be extremely low. In fact, most users only need a few minutes' explanation on a single example. Thus on-site staff may be successfully trained even online over the phone or by a remote desktop application. This is an immense benefit, since direct entry of data by the on-site staff greatly speeds up the data capture process.

The permission-restricted access for users

  • Restricts write access or makes sections completely invisible to users.
    The permission model ensures that all registered users can only see data they are supposed to see and only write to sections for which they have been granted write permission. This opens up a variety of possibilities.

  • File system-like behaviour
    The permission system works just the way you know it from your hard disk or your shared folders. A permission which is set for a specific element, for example a centre list, is valid for these elements and every lower level, just until a new permission is set for this user at an element stored at a lower level of the centre list, for example a subject list. This way you have to set only permissions for the areas you wish to assign to each user.

  • Change log / Audit trail for permission settings
    Just the way all changes to the data are collected in an audit trail, the same is true of all changes to the data permissions. The combination of these two data storages allows to verify whether the changes as recorded in the data history are truly valid in regard to the sponsor's defined permission settings.

Customizing

  • Customized data elements and other extensions
    ue to its flexible, object-oriented design, it is very easy to add new data types, restrictions, reporting or other extensions to EasyClin®, while still taking full advantage of all the already existing features. While we constantly keep adding features to the regular distribution of EasyClin® ourselves, we are also implementing customer-specific features on request.