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 to patients faster

Key points:

• A top CRO chose 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 was looking for 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 wanted to keep its existing LIMS, the sunset product needed to be replaced. The CRO evaluated the vendor’s alternative product but found it did not meet its needs and vision for the future. The software required substantial coding-intensive configurations, meaning significant 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 happen.

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, were all time-consuming.

The solution criteria

The CRO was looking for a solution that would go beyond the core value proposition and deliver data quality, reproducibility, and consistency. Moreover, there was a need to accelerate quality control (QC) and to operationalize data governance and continuity.

The company also sought flexibility for reagent preparation and procedure execution needed for large molecule assays and auto-population of relevant fields.

Finally, the CRO required more details 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 the way the data flows. IDBS’ solution checked all the boxes: data reporting, assay management, and equipment management.

IDBS offers out-of-the-box solutions for several key BioPharma workflows for rapid implementation, along with the capability to configure workflows to meet customers specific needs. The CRO had unique requirements across the organization, diverse types of assays and distinct documenting habits, as all teams were operating differently.

The CRO requested a few changes to the workflows to suit its method of working, which IDBS was able to accommodate. The company employees were trained on the intuitive software so they could make some changes in the future.

As the CRO works with various sponsors, each with different projects and assays, in a compliant environment, they valued the structured workflow and execution that IDBS could offer, enabling a degree of automation.

For example, if a user accidentally exceeded a step in a procedure, the system would let them know right away.

They also liked the systems ability to capture and manage different methods using a single template; that’s the backbone of Polar BioAnalysis. No need to custom-build an assay template from scratch every time a sample comes in. With Polar, they can access that method faster than ever before.

The solution – service

One of the other considerations, when choosing a partner, was the suppliers expertise. IDBS, a global life sciences software company and leading innovator in BioPharma Lifecycle Management (BPLM), has over 30 years experience working with a diverse list of customers, including 22 of the top 25 global pharma companies and five of the leading global bioanalytical CROs. Our deep expertise in scientific informatics and data management solutions enables our customers to tackle today’s most complex challenges.

The impact

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

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

• Mitigating the risk of missing / incomplete data using templates which simplify data capture throughout the experiment and promote best practices.
• Increasing the degree of automation, reducing errors and promoting efficiency and the cost of wasted raw materials and optimizing efficiency.
• Allowing full traceability of materials, samples and equipment used for faster troubleshooting and better inventory management.
• Streamlining review workflow with greater clarity on data sources, data integrity, and basis of calculations.
• Collaborating and sharing of information more efficiently across groups, leading to faster innovation.

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