Transforming the Way Biologic Therapies are Brought to Patients

This biopharmaceutical company is dedicated to unlocking the potential of biosimilar medicines and transforming the way biologics therapies are brought to patients

The challenge

The biopharma companies focus was to improve data integrity, employee efficiency and data analytics by implementing an end-to-end integrated data management system.

Moreover, while the teams had standardized templates, they were paper-based, and so have the same challenges of any paper-based system: not being adaptable to process changes or supportive of compliance with modern regulations. This company no longer wanted to let data capture come in the way of innovation.

The solution criteria

The biopharma company had two key requirements: to simplify and automate data capture from instruments and systems, therefore moving away from data transcription in paper forms, and to guarantee data integrity of all its data within the lab.

The company was looking to improve efficiencies. It wanted to do what it was doing, but better.

And it wanted to take its data management a step further: recognizing the need to simplify review from regulatory bodies, it wanted a simpler process which would enable improved auditability.

With a vast research team, the improvement and modernization in data capture methods would lead to significant improvement in the time dedicated to the research and development of new therapies.

The solution

It chose IDBS because our solution ticks all the boxes. Polar offers an adaptable solution to automate data capture and audit by exception, which highlights errors in data at the point of capture, as opposed to flagging data issues during QC.

In addition, the Polar platform standardizes the way information is captured through templated workflows, encouraging adherence to the F.A.I.R. principles. The instrument integration ensures the data is searchable and reportable and enables groups to work more collaboratively.

Polar’s three pillars – workflow, integrations and insights – appealed to the biopharma company.

The deployment

IDBS’ ROI model highlights the significant return that can be achieved by reducing the dependency on non-productive paper-based processes, streamlining data capture, and cutting report time by 60%. The model estimates a savings of $500k a month as a result.

This ROI model is developed based on IDBS’ extensive experience. Together, IDBS and the biopharma company worked on how the latter could achieve its goals through adopting IDBS’ cloud-based data management system, Polar.

Polar will enrich its data management and ensure the biopharma company leads the regional market.

While it initially had some concerns around the security of its data in the cloud, IDBS was able to address these head-on and facilitate the move into the cloud.

IDBS’ Cloud Validation Services

Another reason the biopharma company chose IDBS is for the IDBS Cloud Validation Services, offering IQ, and automated OQ and PQ. A fully validated, compliant software solution is vital to the biopharma company and this point was seen as an advantage of the IDBS offering over other vendors.

Providing an extensive validation package reduces the high investment the biopharma company teams would have needed to invest and lifts the responsibility of managing this themselves.

The IDBS solution is available and ready; this was one of the main differentiators and therefore a major decision factor in the process.

The move to Polar

IDBS’ customer event, i³, gave the biopharma company all the information it required to reassure it that adopting the cloud solution was the best option for its future.

Executing a quick two-week hands-on workshop and studying the ROI model that IDBS built convinced the biopharma company team to implement Polar. In addition to ensuring it will be prepared for its future, Polar will also enable it to scale as it focuses more on biosimilars.

Futhermore, by using the best-in-class software, the biopharma company will be able to attract and retain new talent, and the best talent.

To further support the biopharma company, IDBS developed a local support team in South Korea. There will also be implementation teams across both organizations who will work on an accelerated implementation timeline.

The future of our partnership

Going forward, the biopharma company will benefit from the value of insight from its data.

The team is excited to see how the implementation of good practices in data capture will enable it to get access to intelligent analytics.

About the biopharma company

The biopharmaceutical company is dedicated to unlocking the potential of biosimilar medicines and transforming the way biologics therapies are brought to patients. It wants to enhance the lives of patients through its pioneering and innovative use of science and technology.