Thermo Scientific Watson LIMS Software for Bioanalysis – Now on The Cloud

Bioanalytical testing plays a critical role in drug development; providing vital pharmacokinetic, pharmacodynamic, and immunogenicity data on a potential therapeutic. Bioanalytical laboratories need to have complete management and oversight over items such as sample management, study protocols, assay development and validation, analytical runs, and the flow of data. Implementing a laboratory information management system (LIMS) promotes visibility, quality, and integrity into the management of these items.

Thermo Scientific™ Watson™ LIMS software follows bioanalytical studies for small or large molecule candidates, from initiation through study closeout. The solution enables compliance with regulations including GLP, 21 CFR Part 11, as well as FDA Bioanalytical Method Validation and EMA guidance documents. Study and amendment protocols can be emulated in the system providing assurance that what occurs in the system is in exact alignment with the study protocol. Lab managers can implement and report on method validation parameters, such as precision and accuracy, matrix effect, recovery, selectivity, and stability within the software.

Pharmacokinetic (PK) and immunogenicity (ADA) calculations and analyses can be performed, reducing report turnaround time. Run acceptance criteria, flags for out-of-range results, reassay, and incurred sample reanalysis procedures can all be established in the system. Watson LIMS software enables summarizing assay performance results and study sample results, including the assembly of datasets into SEND and SDTM format.

Smaller CROs need not worry about the initial IT hardware costs and ongoing support requirements of adopting the industry-standard LIMS for bioanalytical study management. Deploy Watson LIMS software in the cloud to enable secure and scalable end-to-end study and data management.

What are the benefits of Watson LIMS software?

• Study design and sample management 

Build study designs with the aid of Import Study Protocol to upload sample manifests using templates to decrease metadata transfer errors. Create sample names and sample metadata to be used from planning through reporting.

• Connect laboratory instruments and software

Reduce the risk of manual transcription errors by automating data capture and management processes.

• Execute efficient reporting and QA review

Generate a full study report including method validation experiments, assay performance and study data within the system. Data can be reported in CDISC SEND and SDTM format to help streamline the submission process.

• Maintain sample chain of custody

Utilize the storage report feature to monitor each sample movement. Items such as sample storage location, shipment records, and freeze/thaw records are all maintained in the system.

• Streamline method validation and sample analysis

Perform concentration measurements for PK as well as ADA analyses. Define run acceptance criteria and flag results that are out of range. Reduce the risk of over- or under-reporting final concentration data with dedicated Internal Standard Review workflow.

• Ensure traceability throughout a study

Complete study records and reports from study initiation through study closeout, including sample chain of custody, assay verification, and reconstruction events using the audit trail.

Features of Watson LIMS software

• Pharmacokinetic capabilities

Performs non-compartmental pharmacokinetic and toxicokinetic calculations and analyses from back-calculated concentrations generated in the LIMS to support in vivo study PK and drug exposure endpoints.

• Immune response module

Enables the tiered approach for screening, confirmatory, titer, and neutralizing immunogenicity assays to support in vivo study immune response endpoints.

• Run acceptance template and reassay decision matrix

Assesses run performance against pre-defined criteria and creates system flags for out-of-specification results. A graphical workflow of reassay decisions can be configured to automate decisions and adhere to defined procedures.

• Incurred sample reanalysis

Provides built-in calculations and template options to report on incurred sample analysis results.

• CDISC datasets

Export non-clinical and clinical datasets in accordance with implementation guides for PP, PC, LB, and IS domains.