Why EasyClin

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Headline: 
Why EasyClin?
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The following considerations led to the development of EasyClin.

The data flow from the study site staff via the clinical monitors to the management or the sponsor takes much too long in the case of large clinical studies.

Real-life practice has shown, it may take weeks until all study project-relevant data are collected, entered into spreadsheets or email and finally put together from all the various data formats into a single data sheet manually. For this reason, the project management often had to decide on the basis of outdated data.

  • More and more data are 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 needs – a document management system will be required sooner or later. As any computerized handling of files is regulated by national or international directions, mostly based on FDA requirement 21 CFR Part 11, existing document management solutions would require extra validation for each server setup, resulting in higher costs.

  • Clinical projects performed in different locations put greater demands on information availability, access and reliability than most other kinds 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 of platforms for which the system is suitable. Even worse, most specialized solutions require training for every participating staff member on-site. Workaday life, however, shows this 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 are too many unpredictable possibilities that might emerge. For example, a study protocol requires new data, new software has to be updated or extra implementation work is necessary. For this reason it must be feasible to set up and adapt clinical studies on the fly, instead of waiting for protocol finalization to be sure the data requirements of the study are determined so that the software implementation can finally start. Furthermore, the used software must be kept running during structure changes so that the daily work is not affected by necessary updates.

  • Many more practical problems add to the already existing difficulties.

Inevitably, pre-defined forms or spreadsheets are altered by users according to their own requirements, making a unified data overview even more problematic. Data are most often transferred by unencrypted email causing an enormous problem for security. It has also shown that more unnecessary errors accumulate since data records are often evaluated manually (typing data from paper sheets into the computer, the conversion from various text formats and emails into the final report format), resulting in increased workload.

EasyClin has been developed since the solutions available did not fulfil the requirements listed above.

EasyClin solves the existing problems using the following approach:

  • EasyClin® integrates all requirements into a single solution that is already designed for a FDA 21 CFR Part 11 compliant workflow.

The CTMS includes a uniform data input for every user. It always encrypts transmitted data and allows export, reporting and archival in HTML, XML, PDF or Excel. EasyClin® also enables the user to create individual reporting on their own without having to apply any changes to the software. Since everything is integrated into a single system, only one system has to be set up and maintained. Therefore the required amount of training, manual work and the overall costs are reduced drastically.

  • Data have to be entered only once into the database and are instantly available to every user.

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. The data may be used for reporting or data export at any time so that the amount of work of the staff involved is considerably reduced, while data quality and availability are substantially increased.

  • EasyClin® uses an extremely simple approach to coordinate the information.

This CTMS allows users to browse intuitively through the data with no training at all. For entering or modifying data, most users only need five minutes for a simple explanation. In conjunction with the AJAX-based interface, the necessary training can be realized individually online, over the phone or by a remote desktop application.

These – and many other capabilities listed on the “Features” page – render possible much easier and safer information management than before, while allowing access to the stored data without any delay. EasyClin® is extremely easy to learn. This makes it possible for on-site staff to enter data with less help and supervision being necessary, thus speeding up the data capture process even more. Since 2007, EasyClin® has been in use for several clinical trial projects and different pharmaceutical companies. EasyClin® as a CMTS has proved to be a flexible, reliable and stable tool for all kinds of data tracking and evaluation during the entire clinical study process, also including management of working time and financial data.