E-WorkBook seamlessly integrates with customer’s LIMS to create ADA study reports across multiple runs and assay tiers, saving significant study reporting time

The BioPharma company has adopted IDBS’ E-WorkBook platform to address siloed and time-consuming data reporting.

The challenge

This company’s bioanalysis group is currently using IDBS to capture the process around small molecule study execution. They wanted to extend their capability to include immunogenicity testing, supporting three-tiered anti-drug antibody (ADA) assays (screening, confirmatory and titration) for their large molecule programs. The group uses a LIMS platform for ADA study design, data analysis and report generation. However, the LIMS’ output was not in the desired format and scientists were still relying on Excel to manually collate the data for all tiers and format it into a comprehensive report.

Manual data handling in Excel is time-consuming, cumbersome and has an increased risk of human error. It can take one full day to manually compile run data, so scientists wait until the end of the study to perform this step. This often means errors and missed samples are identified late in the process, thus requiring additional time to investigate and potentially re-analyze samples.

The solution

The customer needed a solution that seamlessly integrated with their LIMS to retrieve and collate ADA study data from multiple runs across three assay tiers into a single, collated report. Scientists wanted an automated process for data retrieval, result calculation, data formatting and data flagging based on acceptance criteria. The solution needed to be efficient and flexible to handle various types of ADA study designs.

The customer collaborated with IDBS to integrate with their LIMS for the ADA study reporting solution. An iterative approach was used to carefully identify the desired information in LIMS for data retrieval. Upon successful data retrieval into IDBS’ platform, the data has been organized for each result: mean, % CV, % inhibition and tier results. The data is flagged based on acceptance criteria to visually identify samples that require re-assay or those not analyzed per the appropriate tiered strategy. The final formatted report is easily exportable for sharing.

The outcome

A flexible, time-saving reporting solution has been achieved with seamless integration with E-WorkBook and the customer’s LIMS. This easy-to-use, one-click report will save valuable time and effort around data compilation. Manual data handling is removed, thus increasing data integrity and decreasing quality control review time. Scientists will be able to run reports easily and more frequently during study execution. This will provide more visibility of their data and early detection of errors. An overall estimate of time saved is at least one day per study report.

The IDBS difference

According to the customer, IDBS’ platform has enabled study execution, documentation, data capture and data reporting to be harmonized and standardized, making their overall process more efficient with significant time-saving in study reporting. User training and adoption are also straightforward because of consistency in solution design.

In the future, this customer is planning to implement other workflows to make study execution, data retrieval and data reporting faster and easier for scientists and is also considering upgrading to IDBS Polar. Additionally, they hope to automate data retrieval and reporting wherever possible. Other areas of interest include Sample Management and Reporting solutions and Validation Study Report implementation.

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