Features

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, it is entered directly into the system and so at once 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 A single central storage will make sure that no duplicates of data records or outdated data copies exist.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 ensures that even in case of a total server facility loss no data is 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 clicking your mouse while everyone else is able to continue working.

• High 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 vanishes from the display – but it is still kept inside the data-history forever. This storage may be used to reconstruct the whole database for any given point in time, exactly the way it was. This makes it even possible to re-run a reporting: 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 EasyClins 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 if you want to process the tracked data with some other software create your own reporting or simply need some data right now as an Excel sheet. EasyClin makes it possible to export your data to Excel, run reporting’s which may create many output formats ranging from plain text over PDF, Postscript, Excel, HTML or export the raw data to XML.

• The data may be archived into a simple set of HTML-files which are viewable without EasyClin using any web browser. 

Once the project has been finished, all the 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 into HTML-documents. These may be simply written to 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're 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 all computers without any additional software installation. Simply because EasyClin only requires a JavaScript enabled web browser installed, which is the case on practically all new computers. No matter what operating system is used. To compute an up-to-date Internet Explorer, Firefox or Safari browser, you can access your data via EasyClin even from computer 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 proven to be extremely helpful in case a computer is collapsed. From a personal computer you just log into EasyClin without any further delay.

• The interface is based on AJAX, making the application feel 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, which 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, also without any further software installation. This is the same encryption mechanism used for online-banking and other sensitive applications. It provides a strong measure of safety, especially compared to the non-encrypted usage of email.

• True multiuser-capabilities

Many users can access the database at the same time and view all the data they have read access to. 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 those user are not accidentally writing into the same data field and also helps with the file management. As long as a user keeps a file locked he can work on it exclusively and can be sure if he uploads the new version of the file, no data has been altered after the lock was granted.

• Unified handling for all data guarantees minimum training requirements. 

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

The permission restricted access for users.

• Restrict write access or make sections completely invisible to user

The permission model ensures that all registered user can only see data they are supposed to see and only write to sections they have been granted write permission for. This opens up a variety of possibilities. For an example, you can grant a study monitors write access to their centers only, whereas they are allowed to read data from other centers. It is possible to allow on-site staff to write data into specific sections only, while everything else in your data storage is completely invisible to them.

• File-system like behavior 

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 center 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 center list, for example a subject list. This way you have to set only permissions for the areas you wish to adapt for 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 for all changes to the data-permissions. The combination of these two data storages allows verification whether the changes as recorded in the data-history are truly valid in context of the sponsor's defined permission settings.

Customizing

• Customized data elements and other extensions 

Due to its flexible, object-oriented design, it's very easy to add new data types, restrictions, reporting’s or other extensions to EasyClin, while still taking full advantage of all the already present features. While we constantly keep adding features to the regular distribution of EasyClin ourselves, we are also implementing customer-specific features on request.