Case Studies

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Content Migration for a Toxicology and Infectious Disease Testing Laboratory

In order to perform COVID-19 testing, a national toxicology and infectious disease laboratory needed to align its regulatory compliance with its parent company. To meet the objective, the subsidiary had to update its standard operating procedures (SOPs) with content from the parent SOPs that already met CLIA/GMP, GLP, GCP requirements. 

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Clinical Supply Chain Application Implementation for a Global Biopharmaceutical Company

A global biopharmaceutical company was using two legacy applications and unreliable Excel-based tracking tools to manage an extremely complex clinical supply chain supporting hundreds of global clinical trials conducted annually. In order to more effectively control costs, the company decided to implement a new clinical supply chain application to support better planning and management of production, supply and demand for all clinical products.
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Documentation for a New Cell Therapies Manufacturing Facility

A global biopharmaceutical company with a wide-ranging portfolio was building a new cell therapies manufacturing facility (CTMF) for cancer treatments. While the company’s IT department was tasked with creating the digital infrastructure to support the CTMF, they did not have the in-house expertise required to write the necessary regulatory documentation to support full compliance with regulations.

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