IDBS Polar BioAnalysis

IDBS Polar BioAnalysis enables CROs and bioanalytical groups to improve quality, reproducibility and throughput, reduce study cycle times and accelerate time-to-market

Operational benefits
from day 1

Digitize your own workflows or get started with best practice workflows based on more than 25 years experience, to ensure consistent quality in your day-to-day work.

Build your data backbone for easy analytics and reporting

Capture your experimental and study data at the point of work to ensure full data tracking, chain of custody and GxP-compliance when needed. Integrate with key systems like LIMS.

Providing digital solutions that deliver quality, consistency & reproducibility for CROs and sponsors

Download the infosheet to learn how to revolutionize real-time data entry and insights.

Get started with best practice workflows

Ensure quality and reproducibility.

Registration

Integrated inventory management
including sample lifecycle.

  • Samples
  • Materials
  • Equipments

50% reduction in sample preparation documentation

Planning

Enable 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

Real-time identification of exceptions specified in 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

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

bioanalysis illustration workflow process

Integrate with instrumentation and existing software infrastructure

Improve data integrity and quality

Highly contextualized data backbone

Support the process

Bioanalysis process support.

IDBS_AnalyticMethods
Analytical methods
IDBS integration
Integration with IDBS Polar backbone
Monitoring IDBS
ICH M10 analysis
instrument checker

Instrument Check

  • Calibration
  • Fit-for-use
sample handling

Sample Handling

  • Resolving discrepancies
  • Freeze-thaw tracking
  • Benchtop and long term stability
material registration

Material Registration and Reagent Preparation

  • Integrated inventory and recipe management
  • Chemical packets and tablets; multi-solute reagents; lyophilized reference materials
regent preparation

Large Molecule

  • ICH M10 compliance
  • Quantitative ligand binding assay support
regulations

Regulatory

  • Submissions
  • Responses
  • Filing
  • Audit
IDBS Polar BioAnalysis

ICH M10-compliant consistency, quality, and reproducibility for preclinical pharma.

Polar BioProcess

Optimize workflows and integrate process and analytical data to deliver greater insight.

Ask for a demonstration today