Our new data collection system will provide our clients with a greater degree of flexibility in study design, defined measurements, and ultimately in reporting. Other benefits include: statistical analysis integrated into data reports, greater variety of report formats, and a reduction in time needed to complete study reports.
The Xybion Pristima™ system provides our clients with a greater degree of flexibility in study design, defined measurements, and ultimately in reporting. Xybion provides continuous product and service improvements as well as excellent technical support. There is also an independent User Group run by the client community which meets yearly to discuss the system, present issues and make recommendations about the the system to Xybion. Quality Assurance auditors from the User Group perform independent audits of Xybion and the system for FDA GLP and Part 11 compliance and report their findings to Xybion.
There are several features which can improve overall study quality. Among the features:
- More efficient data entry such as manual entry with minimal screen changes, keystrokes and mouse clicks.
- Interfaced data collection for body weights, feeder weights, and any other type of data that could be recorded via an interfaced device such as a balance, barcode reader or clinical pathology instruments.
- Checks to minimize technical errors, including visual matches of an animals group assignment to a designated color, scanning of barcode on dosing vessel prior to start of each group to verify that the correct test article concentration is being used, and scanning of barcode on sample tubes to verify that the correct tube is being filled.
- Master and study lexicons result in consistent and accurate use of measurement terminology.
- Seamless tracking of clinical pathology samples from collection in the animal room, to receipt in the clinical pathology lab, to analysis by the clinical pathology instrumentation with direct data transfer from the instrumentation to the Pristima system.
- Statistical analysis integrated into data reports. If a statistical evaluation is requested that is outside our normal procedure, a specific statistical decision tree can be created from an existing dictionary of statistical tests and incorporated into each individual report.
- Data Reports are available in a variety of formats (PDF, Word, Excel, HTML, CSV, text)
We will also now have the ability to record data for teratology/reproductive toxicology studies on-line and easily generate data tables. Previously, the majority of data we collected for these studies was generated on paper and then manually tabulated, followed by 100% QC check of all the data points to ensure the accuracy of the transcription. With online data collection and table generation, there will be a reduction in time needed to complete study reports.
About Xybion Medical Systems
Since 1977, Xybion has been the enterprise system partner of choice for life science product companies and scientific research organizations worldwide. In addition to Pristima, Xybion provides professional services, consulting, training, and validation activities to clients around the world.
