ClinAxys® provides a feature-rich clinical pathology Laboratory Information Management System that includes all of the following functions:
- Access to a single database by multiple global laboratories
- Centralised entry and editing of study protocol information
- Specimen tracking
- Fast access to accurate information
- Rapid data entry with bar-coded label production
- A user-friendly interface
- Flexible reporting
- Alert flagging of problems or demographic inconsistencies
- The ability to add modules as requirements change
- On-line data capture for leading makes of instrumentation
- Controlled authorisation of results before final reporting
- An automatic audit trail of all changes and activities
- Data flagged against study-specific reference values
- 21 CFR Part 11 facilities
- A full quality control package including Levey-Jennings and Westgard
- General File Import module for importing standard format files such as spreadsheets
ClinAxys® can process large volumes of data from both on-line and manual sources simultaneously, and is designed to comply with current Good Laboratory Practice (GLP) requirements at all times.
Compliance with national and international regulations and guidance, such as the United States Federal Regulations, EU Regulations and OECD Guidelines, is vitally important when you are engaged in Clinical Trials or Pre-Clinical Drug Safety studies. One example is the United States Code of Federal Regulations 21 Part 11 (21 CFR Part 11) concerning electronic signatures.
ClinAxys® is continually updated to be in accordance with current industry recommendations and best practice as well as recent changes to regulations and guidance.