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Pearl Therapeutics’ Regulatory Triumph

Leveraging SciCord for Efficiency Gains:

Unveiling 3x Efficiency Gains at a Fraction of the Cost with SciCord Informatics Platform


Benefits:

Through the implementation of the SciCord Informatics Platform, Pearl Therapeutics’ teams realized significant advantages:

  • Enhanced review process efficiency by over 30%
  • Achieved a 3x increase in efficiency compared to previous solutions
  • Successfully navigated FDA filings and audits
  • Fostered collaborative review processes across multiple sites
  • Enabled seamless remote work capabilities during the challenges posed by COVID-19 and other life events

Situation

In 2015, Pearl Therapeutics, later acquired by AstraZeneca, began its journey as a small company dedicated to developing innovative inhaled formulations. Confronted with resource constraints, Pearl prioritized enhancing laboratory throughput and implementing data trending and visualizations to inform development strategies.

Challenges:

  1. The delivery mechanism would be a metered dose inhaler (MDIs) and would involve multiple physical constituents, an aerosol propellant, and the active drug(s). Each constituent represents a variable to be characterized in the development process and would require many formulation batches and stability trials.
  2. Sample preparation for some analysis is complex with test results potentially influenced by analysis bias.
  3. Simulating the lung entails complex calculations. To perform these calculations, data would need to be transcribed from instrument reports to bespoke software.
  4. Trending and visualizations are key to understanding the impact of formulation and stability data. The data would need to be searchable and available for SQL query by Spotfire & JMP.

SciCord was contacted based on a previously successful inhaled data management solution at GSK by SciCord’s founder.

Impact:

The success of Pearl Therapeutics pivoted on a seamless regulatory filing process. The adoption of SciCord brought forth profound effects:

  • Validated solution integration across all operational functions
  • Structured data and custom reports enabled robust trending and visualization capabilities
  • Streamlined instrument interface for enhanced data management
  • The review process saw a remarkable efficiency improvement of over 30%.
  • Efficiently managed operations across two geographical sites on the East and West coasts of the USA

A Comprehensive Solution for Pharmaceutical Labs

SciCord provides a platform for an entire research and development organization. In our experience, pharmaceutical labs often cobble multiple solutions together and unfortunately isolate data and unknowingly create headaches for an already overburdened IT group.

The Challenges for a
Comprehensive Solution


Pharmaceutical organizations are under extreme pressure to expedite development and their lab operations are not keeping up. Organizations often resort to niche digital solutions to address specific roadblocks.

The Impact of Ignoring
Comprehensive Options


With multiple varying digital solutions in a lab and manufacturing space, data becomes isolated, the infrastructure is complex, and the administration is expensive.

The SciCord Solution


An all-in-one Informatics Platform that can be implemented in weeks instead of months. Lab personnel will have a simple path to gaining digital efficiency. Rapid configuration provides flexibility and a workflow that matches current lab methods.
The SciCord Informatics Platform is an all-in-one solution that manages spreadsheets and contains functionality associated with LIMS, LES, SDMS, and ELN. The SciCord Informatics Platform consolidates data, simplifies the IT infrastructure, and reduces administrative costs. It can also provide specific templates and configurations to different users and departments within your organization, allowing more niche needs to be addressed without breaking connectivity with the rest of the lab.

Acknowledgments:

We extend our sincere appreciation to Shyamala Ivatury (Senior Director, IPD, PT&D, Pearl/Astra Zeneca) for their invaluable guidance and collaboration throughout this endeavor.

More From SciCord


Case
Studies

Case Studies

Formulated Solutions Achieves Operational Excellence with LIMS Implementation

A Case Study of LIMS Implementation Requiring Harmonization Across Multiple Sites and Facing a Tight Schedule

Read More

Pearl Therapeutics’ Regulatory Triumph through Implementation of ELN and LIMS

Through the implementation of the SciCord ELN and LIMS, Pearl Therapeutics’ teams realized significant advantages

Read More

Aurobindo Utilizes SciCord Platform for Successful FDA Filing

The cost of an FDA audit issue can range from tens of thousands to millions of dollars. By implementing the SciCord Platform and improving compliance measures, Aurobindo can avoid or mitigate these costs, resulting in significant cost savings. In addition, the SciCord Platform aided Aurobindo in a successful FDA Filing.

Read More

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What Our
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Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.

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This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.

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Josh Guyer,
Senior Pharmaceutical Scientist



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