Power your Bioanalytical Workflows with Watson 7.7

From initiation through archival, Thermo Scientific™ Watson LIMS™ software is ready to help manage bioanalytical studies. Watson LIMS software is guided by industry and regulatory standards to support pharmaceutical drugs and biologics development. With Watson LIMS, principal investigators, analysts and study coordinators can move logically through each step in their workflow, simplifying bioanalytical support for nonclinical and clinical studies. Pharmaceutical companies and CROs worldwide count on Watson LIMS software to provide a standardized way to work, ensuring seamless data collaboration and reporting.

Version 7.7, the newest release of Watson LIMS software, provides a host of enhancements to reduce risk, save time and further secure data quality. Improvements to reporting formats enable clear mapping and output of clinical datasets, supporting additional variables in CDISC SEND and adding five new domains to support SDTM format.

New and enhanced functionality available in Watson LIMS version 7.7 provides greater value for the principal investigator, the analyst, and the study coordinator. Here’s a look at how each role can benefit from Watson LIMS version 7.7.

 

Value for the principal investigator​

The CDISC SDTM domains for clinical datasets help the principal investigator save time by assembling clinical PK and ADA data according to an established regulation for e-submissions.  The introduction of Study/Run ID check for uni-directional data transfers between acquisition software and LIMS improves confidence in data defensibility, bolstering data integrity. Watson LIMS version 7.7 also supports more PP domain variables for pharmacokinetic parameter results. ​

Benefits for the analyst​

Also new to version 7.7, a dedicated Internal Standard (IS) response review workflow reduces the risk of over- or under-reporting final concentration data based on anomalous internal standard peak area. The system enables criteria to be defined, presents a plot of IS response versus sample sequence number and identifies outliers and sample metadata (e.g. type, dilution factor) to help users identify data trends. Analysts can take action on results failing to meet IS criteria. Lastly, Watson stores a history of the review, along with %CV, providing evidence of review as well as a trend view among many assay runs.  The latest version makes it more efficient for the lab analyst to identify samples that need to advance to the next ADA analysis tier, by grouping positive results awaiting the next tier analysis as well as grouping results which were confirmed negative.​ Visit information is now an optional part of the sample name, enabling easier sample identification in clinical studies​. For ligand-binding assays, %CV of concentration data criteria is now better defined in the assay and flagged in actionable areas of regression analysis. For analysts performing qPCR analysis, there is a new regression model called semi-log.

Helping the study coordinator​

Watson LIMS version 7.7 also provides specific benefits for the study coordinator. The updated user interface provides a clear, intuitive way for study coordinators to identify and eliminate metadata errors and conflicts with existing design samples. Suspect records are quarantined, allowing users to proceed only with valid records. The result is decreased bottlenecks ahead of sample analysis and cleaner metadata to store and report. The import study protocol now includes a template which maps the in-life facility’s study design elements to the design elements of Watson LIMS software, reducing the need for column header edits during study design transfer. Using Watson LIMS version 7.7, the study coordinator can define sample home position to make sample returns to storage more efficient.

Supporting your bioanalytical laboratory

Watson LIMS software provides bioanalytical laboratories with the ability to track their data through each step in the scientific workflow. While optimizing processes throughout the bioanalytical workflow, Watson LIMS software also ensures complete traceability and sample chain of custody. Whether your laboratory is focused on only biologics or has a mixed portfolio supporting pharmaceutical drugs and biologics, Watson LIMS software provides a complete solution for bioanalytical laboratories.

Visit the Watson LIMS website to learn more about Watson LIMS version 7.7 and how it can support your laboratory.