Keeping secrecy and privacy
Keeping privacy during a clinical trial is a must, which might require an extra care in case of a electronic case report form.
Similarly, concers regarding the data safety and integrity are constant fears connected to eCRFs. Being aware of the above facts, we never loose on our strict safety rules and regulations to keep assuring secure handling of our client’s data.
To keeping everything transparent any action (and data-specific change) are logged and stored.
Efficient support of data entry
Qulity depends on the input, so our main focus is on the efficient support of data entry. This support is two-fold: a) system usage is very easy, absolutely self-evident b) data entry is supported with different tools (checks, notifications, auxiliary databases, online guides and human help-desk).
Maximal flexibility in reporting
The way of information retrieval from any data collection system is probably the most important characteristics. In terms of this concept we increased the level of our services to the theoretical maximum: with our pre-build report generation engine ANY information can be retrieved from the database with a maximal felxibility.
Cost-effectiveness which primarily means implementation of new trials within a reasonably short time is an evergreen business claim. To fulfill this demand we introduced the program driven programming approach. In other words paper CRFs, eCRFs (including the checking conditions) are generated from properly parametetized Excel-sheets.
- Fully compliant with FDA 21 CFR part 11
- application of ANY authentication policy
- program-aided data entry: several methods to support data entry
- real time syntactic check of entered data
- application of pre-defined logical checks
- automatic query generation extended with manual query generation
- full audit trail
- status reporting
- availability of reporting templates
- complete advese event managemet
- internal document management
- multilingual environment
- easy data transfer
- 24 hour service desk (human and answering machine).