Customer success storiestest tubes bioanalysis polar

A Top Ten CRO Deploys IDBS Polar for Faster Biopharma Development

This leading Contract Research Organization (CRO) directs its efforts towards bioanalysis, with a focus on bringing life-changing therapies faster to patients

Key points:

  • A top CRO chooses Polar to speed up its biopharma development
  • The CRO was suffering from a lack of efficiency and confidence in its data
  • Polar matched its criteria – delivering the benefits of  data quality, reproducibility and consistency
  • The CRO can see a 20-30% increase in operational efficiencies

The challenge

The CRO had an incumbent data management system which, while mature, was being sunset by the vendor, with the option to move to their next generation offering. The CRO sought a solution including small and large molecule LCMS, Biomarker, ADA, and cell-based assay support.

While the CRO have a LIMS that it’s happy with, it needed to replace the sunset product. It evaluated the vendor’s new product but found it did not cover its needs and vision for the future. The software required substantial coding-intensive configurations, requiring high investment to upscale the business and processes.

The CRO was experiencing issues including a lack of efficiency and detailed review of data capture. This meant that it didn’t have confidence in its data – time stamps were in doubt and expiration dates could be manually changed when pushing reagent data to a consumable system. This should not be the case.

Moreover, the CRO was unable to duplicate its procedures, and was facing problems with issuing reagent barcodes, limiting their use when testing procedures during the design phase. All these issues, compounded with recipe review, are all time consuming.

The solution criteria

The CRO was looking for a solution that would go beyond the core value proposition. It was searching for a platform that would deliver the benefits of quality, reproducibility, and consistency in its data. Moreover, the CRO was looking to accelerate its QC, and operationalize data governance and continuity.

But that wasn’t all! The company sought flexibility for reagent preparation and procedure execution needed for large molecule assays and to auto-populate relevant fields.

In addition, the CRO required more detail at incubation steps, support for multiple plates per analytical run and robust reference standard support.

The solution – product

The CRO chose IDBS’ solution for its highly configurable workflows and how the data flows. IDBS’ solution checks all the boxes: data reporting, assay management, and equipment management.

Polar does not need to be customized, but, if necessary, can be configured to meet a company’s extended requirements. The CRO had unique requirements across the organization, diverse types of assays, and distinct documenting habits, as all teams operate differently.

The CRO understands the science and workflows and has requested a few changes to the workflows to suit its method of working, which IDBS can build up to their requirements. The company employees can also learn the intuitive software to make changes in the future as the learning curve is not steep.

CROs work with various sponsors, each with different projects and with different assays to run, in a compliant manner. The CRO liked the structured workflow and execution enabling a degree of automation

So, if a scientist accidentally exceeded a step in the procedure, the system would let them know right away. They also like the system’s flexibility to be able to capture and manage different methods using a single template; that’s the backbone of Polar BioA. No custom-building an assay template from scratch every time they get a sample in. With Polar, they can access that method faster than before.

The solution – service

Another reason they chose IDBS is its expertise. Experience in the field built credibility and rapport with them and showed them that the IDBS platform is the way forward. IDBS has a long and successful history delivering bespoke, domain-specific solutions to our customers in biopharma development. We consider it our “advantage position” — from the standpoint of our multi-dimensional data modeling capability, and the subject matter expertise resident in our delivery teams.

We find that successful project delivery hangs on a “definition of done” developed in close consultation with the scientists who are our customers. This approach, built on rigorous requirements, enables our customers to avoid unpredictable delays and pre-empt any misalignment on deliverables. We have delivered new capabilities via this methodology to our other customers, including five of the leading global bioanalytical CROs.

The impact

The CRO can see improved operational efficiencies of 20-30% and faster sample throughput when completing work for their customers.

In addition to the efficiency gains identified there are other benefits which are potentially even more valuable.

  • Mitigating risk of missing / incomplete data using templates which simplify data capture throughout the experiment and promote best practices
  • Increased degree of automation, therefore reducing errors and promoting efficiency and reducing the cost of wasted raw materials
  • Full traceability of materials, samples and equipment used for faster troubleshooting and better inventory management
  • Streamlined review workflow with greater clarity on data sources, data integrity, and basis of calculations
  • Greater collaboration and sharing of information across groups leading to faster innovation

These benefits represent additional value beyond the financial business case.

We are eager to collaborate with your team to produce a solution that delivers benefit to quality, reproducibility, and consistency in bioanalytical operations.

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