SciCord

A Case Study in the SciCord Comprehensive Solution:

Pearl leverages the SciCord Informatics Platform to record and manage data for regulatory filing.

Benefits:

By utilizing the SciCord Informatics Platform, the varying teams at Pearl Therapeutics were able to obtain the following benefits:

  • Improved the review process by >30%​
  • 3X more efficient than previous solutions
  • Successful FDA Filing & Audits
  • Collaboration on reviews across sites
  • Work from home during Covid and other life events

Situation

In 2015, Pearl Therapeutics was a small company developing novel inhaled formulations. As a small company, Pearl was resource constrained and needed to increase laboratory throughput and then perform trending and visualizations on the data to guide development.

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 fate of the company hinged on a successful regulatory filing!

  • Validated solution across all functions
  • Structured Data for trending and visualizations
  • Instrument interface
  • Manage 2 geographical sites (east/west coast USA)


Shyamala Ivatury
Senior Director, IPD, PT&D, Pearl (Astra Zeneca)



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