Why EasyClin?

The following notion has led to the development of EasyClin:

The flow of data from the site-staff over the monitors to the management or the sponsor takes much too long for large clinical studies
Real-life practice had shown it could take weeks until all relevant subject data was collected, entered into spreadsheets or E-Mail and put together from all the various data formats into a single data sheet manually, and so the management often had to decide on the basis of outdated data. Existing software for automated project management was practically not usable for clinical studies, did not have any online-capabilities or was just not affordable.
More and more data is kept in computer files, making a 21 CFR Part 11 compliant document management a requirement for inspections
In order to manage computer files – and to keep up with the constantly increasing security, storage, availability and versioning requirements – sooner or later a document management system will be required. As any computerized handling of files is regulated by national or international directions, mostly based on 21 CFR Part 11, existing document management solutions would require an extra validation for every server setup, adding even more to the costs.
Clinical projects performed on different locations make great demands on information availability, access and reliability than most other kind of projects.
Since a large part of the information should be captured and entered on-site, using an existing solution would require some kind of software-installation, thus limiting the number platforms the system is useable for. Even worse, most specialized solutions require training for every staff member on site, which is usually not possible under practical aspects.
A customizable, online reconfigurable data structure is required.
Trying to build a system using a pre-defined data structure simply does not work. There's always some kind of study protocol requiring a data field which just could not have been foreseen, making a new software update and extra implementation work necessary. It must be possible to set up and adapt studies on the fly, instead of waiting for protocol finalization to be sure the data requirements for a study are fixed so that the software implementation can begin. Furthermore, the software must be kept running during structure changes so that the daily work is not affected by these updates.
Many more practical problems add to the already existing difficulties:
Inevitabely, pre-defined forms or spreadsheets are altered by users due to their own requirements, making a unified data overview even more problematic. Data is most often transferred by unencrypted E-Mail, which poses a huge problem for security. It has also shown that since data records are often evaluated manually (typing data from paper sheets into the computer and conversion from various text formats and E-Mail into the final report format), unnecessary errors start to accumulate and the workload increases.

EasyClin was developed since in our opinion already available solutions did not fulfill the requirements listed above.

EasyClin solves the given problems using the following approach:

EasyClin integrates all requirements into a single solution, which is already designed for 21 CFR Part 11-compliant workflow.
It includes a uniform data input for every user, always encrypts transmitted data, allows export, reporting and archival in HTML, PDF, XML or Excel, which allow the users to even create reporting on their own without having to apply any changes to the software. Since everything is intergrated into a single system, only one system has to be set up and maintainted. The required amount of training, manual work and the overall costs are reduced drastically.
Data has to be entered only once into the database and is available to every user instantly
Since the permissions of every user can be defined for every single data element, the on-site staff members can enter data on their own. This data may be used for reporting or data export at any time, so that the amount of work for the staff involved is considerably less than before, while the data quality and availability drastically increases.
EasyClin uses an extremely simple approach to handle the information
This allows users to browse the data with no training at all. In order to enter or modify data, most users need five minutes of simple explanation. In conjunction with the AJAX-based interface, this kind of training can be realized online over the phone or a remote desktop application.

These – and many more capabilities listed on the “features” page – allow much easier and safer information management than before, while allowing access to the stored data without any delay from everywhere. EasyClin is extremely easy to learn, making it possible for on-site staff to enter data while needing less help and supervision, thus speeding up the data capture process even more. Since 2007, EasyClin has been in use for different projects and companies and has proven itself to be a flexible, stable foundation for all kinds of data tracking and evaluation, including management of working time and financial data.