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Case Studies

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Enabling AI in highly regulated environments 

GxP Compliance in half the time


Key Insight: ​
Most AI companies fail in regulated markets because theY treat compliance as an afterthought, not a design principle.​


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GxSpeed partnered with a cutting-edge AI company developing computer vision for quality review and diagnostics. We navigated FDA validation requirements, designed audit-ready documentation frameworks, and created compliant deployment protocols – accelerating their life sciences market entry while maintaining regulatory integrity. 

Accelerating clinical operations at Fortune 500 Pharma –​

Reduced CRO coordination time by 25% through automation​

Key Insight: ​Most clinical tech custom applications fail because they are built by software companies who don’t understand the industry or its requirements.

We developed integrated applications that streamline trial management workflows, automate regulatory reporting, and provide unified access for internal teams and external CRO partners. The applications eliminated manual hand-offs and reduced time-to-database lock by several weeks per study.​

Transforming CDMO Onboarding:

Cut new client integration time from six months to six weeks​

Key Insight: ​Contract manufacturers lose millions in revenue when newcapacity sits idle due to onboarding bottlenecks




We redesigned the partner onboarding process by mapping technology dependencies, standardizing data, and building automated workflows. This enabled utilization of new manufacturing capacity within weeks instead of months.
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Optimizing Medical Device Distribution 

Enabling accurate forecasting while reducing distribution costs


Key Insight: ​Medical device supply chains require different optimization than other industries, including pharmaceuticals.​

We evaluated North American logistics operations, identified 3L partnership opportunities, enhanced warehouse operations, and improved predictive analytics for demand planning. The integrated approach improved both reliability and cost efficiency.
 – accelerating their life sciences market entry while maintaining regulatory integrity. 

Global OperationsTransformation Strategy–​

Aligned tech and data strategy for a$1B expansion 

Key Insight: ​Most tech transformations fail because technology decisions are made in isolation from business strategy and operations.

We orchestrated a transformation plan for technology and data as the company expanded globally through its acquisitions to standardize functions across regions, rationalize vendors, and build scalable tech infrastructure to support current operations and future growth.

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Bio-analysis Platform Validation

Validating next-generation lab systems


Key Insight: ​Most new life sciences platforms struggle because they try to retrofit compliance into existing systems instead of building validation into the architecture from day one.​

GxSpeed partnered with a life sciences tech start up developing an automated bio-analysis platform engineering for dramatically accelerated clinical testing. 


We designed and implemented comprehensive validation protocols for their lab systems, ensuring FDA compliance while maintain the speed advantage that differentiates their platform.

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Rationalizing Bank Procurement Operations

Cut contingent labor costs by 20%while establishing quality governance framework


Key Insight: ​Most organizations treat Procurement as a cost center that negotiates contracts when it should ensure both cost efficiency and work quality from external resources.

GxSpeed partnered with a with a commercial bank's newly promoted Chief Procurement Officer to address runaway contingent labor spending and lack of procurement oversight. 

We analyzed their contingent workforce spend, renegotiated rates with preferred providers, rationalized the vendor ecosystem, and established comprehensive work oversight protocols—including key performance metrics for all external resources and projects.