XClin Trials is NovaXon's solution for clinical studies, marketing studies and registries. XClin Trials is an advanced software system that support both conventional paper based processes, and the more recent electronic data capture (EDC). The software is flexible to allow several users including investigators, statistical experts, monitors, and sponsors access to the same data. All with different rights and possibilities. Flexibility is of extreme importance in the use of such systems. Therefore NovaXon ensures that its systems are flexible and user friendly. XClin Trials features both a web based solution and a desktop solution, thereby allowing the users to access the system offline. (for example on a laptop or tablet PC)
Strong advantage of XClin Trials are:
Highly intuitive status indicators point out which data is required, optional, completed, erroneous, reviewed or source data verified. Learning how to use XClin takes only a few minutes. XClin is one of the few applications where components in the eCRF can be placed with complete freedom. Finally eCRF's can look exactly like paper CRF's.
By using intelligent electronic case report forms, data quality is improved significantly and many unnecessary queries are prevented by early detection of out of limit values, logical errors or protocol violations. Forms can be customized to include functionality specific to each companies specific needs, such as upload and analysis of device output, communication with other devices/databases, etc.
Working Off line
XClin can be used off-line. It is therefore possible to fill in Case Report Forms in a private office or at a patient's bedside. Study monitors can review forms while traveling. They can also perform source data verification with patient hospital files at a clinical site. In both cases there is no need for an internet connection. Field employees can always bring patient forms on their laptop/Tablet PC and discuss these with investigators during a visit.
Security & Validation
XClin uses the most stringent security measures. Data is strongly encrypted before transfer.
To conform to the current regulation, XClin has been validated. XClin is also conform to all the GCP and FDA (21 CRF part 11) requirements.
NovaXon and XClin have been audited for their full compliance.
Study status Online & Export
From any place in the world, the status of the clinical study may be checked by opening a dedicated website. Export of data is also very easy and is fully customizable depending on user rights. Data can accessible in read-only mode from any place through the web interface.
Cycle time reduction
Thanks to XClin you can rethink your clinical process and gain in quality and efficiency. The electronic collection of clinical data directly at the investigation sites (EDC) can be the source of many benefits, but Xclin can also benefit you in other ways. Thanks to XClin, it is possible to continue working with paper CRF and still gain in efficiency and flexibility. Data entry can be done remotely or subcontracted. Data management and verification is simplified through better communication between the parties involved.
Platform independent & Deployment
XClin works on Windows, Mac OS and Linux. Furthermore XClin is easy to install and new versions of electronic Case Report Forms are automatically deployed if necessary each time a user connects to the system.
For the few cases where any installation is prohibited, XClin is also available as a 100 % web application. The layout and the functionalities are identical.
- Compliant with the FDA CRF 21 part 11 regulations
- Optimal ergonomics
- Secured by using the latest technologies
- Flexible access rights
- Full audit trace possible (Who did what and when)
- Internal e-mail system
- Progression/management reports
- Double data entry
- Validation at data entry
- Query module
- Export module (SAS, CDISK and Excel)
- Data Source Verification possible on field, section en form level
- 2 versions: Web and Desktop edition (offline capabilities)
- Voice recording
- Tablet PC compatible
For who is XClin Trials meant for:
- Contract Research Organizations (CRO's)
- Biotech companies
- Pharmaceutical companies
- Universities/research institutes