IDBS Polar BioAnalysis

IDBS Polar BioAnalysis allows CROs and biopharma to improve quality and reproducibility, reduce study cycle times and accelerate time-to-market.

Operational benefits
from day 1

Best practice workflows based on more than 25 years’ experience ensure consistent quality in your day-to-day work.

Access to the IDBS Polar data backbone

Ensures a full data continuum for shorter time to market and faster filing for those who come after.

Generate your reports faster

Capture deviations in real-time and simplify reporting.

Typical study timeline

Typical study timeline

Study timeline with IDBS Polar BioAnalysis

Study timeline with IDBS Polar BioAnalysis

Best practice workflows

Ensure quality and reproducibility.

Registration

Integrated inventory management
including sample lifecycle.

  • Samples
  • Materials
  • Equipments

50% reduction in sample preparation documentation

Planning

Allow Study Directors and Principal Investigators to define the recipes, procedures and parameters of the methods and assays that will be conducted, ensuring that execution is repeatable.

  • Reagent Recipe

  • Method Definition
  • Analyte Solution Recipe

  • Ligand Binding Assay Definition
  • Method Validation Recipes

100% elimination of deviations specified within the method

Execution

Document the procedures and preparations of bioanalysis, ensuring quality while retaining flexibility. Capture data in a consistent and traceable way, flag exceptions in process for immediate correction or explanation, and log all items used including genealogy tracking.

  • General Equipment Check
  • pH Meter Check
  • Balance Check
  • Pipette Check
  • Reagent Preparation
  • Analyte Solution Preparation(s)

  • Analyte Solution Preparation(l)

  • Sample Setup (LIMS)
  • Procedure
  • Instrument Setup
  • Sample Setup (non-LIMS)
  • Ligand Binding Results Import
  • Validation Stability Logging

75% reduction in QA/QC time

Reporting

Summarize results across the execution workflows within a study including the calibration curve, quality controls, validation and stability assessment sample.

  • Equipment Check Report
  • Exception Report
  • Usage Log
  • Post Process
  • Ligand Binding Study Report
  • Ligand Binding Validation Report

50% reduction in overall study duration

Integrate for improved data quality

Group 10

Integrate with instrumentation and existing software infrastructure

Improve data integrity and quality

Highly contextualized data backbone

Support the process

Bioanalysis process support.

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Analytical methods
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Integration with IDBS Polar Backbone
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ICH M10 analysis
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Instrument Check

  • Calibration

  • Fit-for-use

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Sample Handling

  • Resolving discrepancies

  • Freeze-thaw tracking

  • Benchtop and long term stability

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Material Registration and Reagent Preparation

  • Integrated inventory and recipe management

  • Chemical packets and tablets; multi-solute reagents; lyophilized reference materials

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Large Molecule

  • ICH M10 compliance

  • Quantitative ligand binding assay support

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Regulatory

  • Submissions

  • Responses

  • Filing

  • Audit

See a demonstration