Case Studies
Developing a Comprehensive GxP Validation Package for Major Clinical Software
A market-leading Clinical IT vendor was preparing to launch a new, simplified version of their clinical supplies management software specifically for mid-market customers. To ensure a smooth and successful adoption, they needed a revamped validation package that catered to this new audience.
Setting Up for Success
In an era when artificial intelligence (AI) could revolutionize the healthcare industry, a dynamic startup, harnessing AI to identify clinical candidates with therapeutic needs, found itself on the fast track to growth. With rapid expansion the startup needed to align its IT policy with widely adopted NIST SP500-53 requirements and internal control standards, as defined by the Committee of Sponsoring Organizations (COSO) framework. Recognizing these challenges, the startup turned to Kalleid, known for its expertise in supporting life sciences and pharmaceutical companies through similar compliance landscapes.
Customer Training Program for an R&D Data Cloud Company
A major software company that helps many of the top global pharmaceutical and life science companies unlock siloed R&D data with a cutting-edge, cloud-based data platform wanted to transform their customer experience to promote increased customer retention, expansion of use, and differentiation from other tech firms.
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.
Clinical Supply Chain Application Implementation for a Global Biopharmaceutical Company
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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