Building an AI-Driven Imaging Platform For A Global Biotech Leader
challenges
As imaging data volumes and clinical complexity increased globally, the organization faced mounting challenges across data management, regulatory compliance, and operational efficiency. Disconnected systems and manual workflows slowed access to critical insights, increased costs, and heightened compliance risk that ultimately limited the pace of innovation across clinical trials, R&D, and commercialization efforts.
Key challenges included:
• Fragmented imaging and clinical data across regions and systems
• Increasing regulatory scrutiny and FDA compliance requirements
• Inefficient validation and review processes slowing time to insight
• Operational bottlenecks impacting clinical trials and R&D velocity
• Elevated direct costs, missed revenue opportunities, and legal exposure
solutions
The organization selected NextPhase.ai to design and implement a global, AI-driven imaging platform aligned with its existing technology ecosystem and regulatory requirements. NextPhase.ai delivered a scalable solution that unified imaging data, enabled advanced analytics, and supported regulated clinical environments across multiple therapeutic areas that included: oncology, neurology, ophthalmology and notably, a tumor algorithm recognized and published by the American Society of Hematology.
Core solution capabilities included:
• A global imaging platform seamlessly integrated with existing systems
• Dynamic AI algorithms supporting oncology, neurology, ophthalmology, and clinical use cases
• Built-in data validation and governance workflows to meet FDA standards
benefits
The modernized imaging platform established a secure, scalable foundation for clinical insight, regulatory confidence, and operational efficiency by driving measurable improvements across the organization.
Key outcomes included:
Operational Efficiency: Streamlined imaging workflows reduced inefficiencies and lowered operational costs
Accelerated Data Access: Reduced time to access validated imaging data from four weeks to one day, enabling faster, more informed decision-making
Regulatory Confidence: Strengthened compliance with regulatory requirements, significantly reducing non-compliance risk
Improved Validation Performance: Increased FDA-related data validation efficiency by 40%, accelerating clinical and R&D timelines