Comprehensive Case Study - Combined

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:

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.
Sample preparation for some analysis is complex with test results potentially influenced by analysis bias.
Simulating the lung entails complex calculations. To perform these calculations, data would need to be transcribed from instrument reports to bespoke software.
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)

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.

Platform and Features

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