Data Insights & Control

GenAI & ML Enablement in Life Sciences

Discover the full potential of AI using a structured approach to assess readiness, optimize infrastructure, and develop responsible AI strategies.

Optimize AI-Driven Data for Life Science Governance, Transparency, Integrity, and Compliance.

USDM’s GenAI & ML Enablement empowers Life Sciences organizations to harness the full potential of artificial intelligence within a compliant, audit-ready framework. From automating content workflows to enabling predictive insights across Quality, Regulatory, and R&D domains, our capabilities integrate GenAI and machine learning with GxP best practices to drive operational efficiency, data integrity, and faster decision-making. With a focus on trustworthy AI and harmonized governance, USDM helps life sciences leaders accelerate innovation while staying ahead of evolving regulatory expectations.

AI Maturity Assessment & Governance Model

Evaluate your organization’s AI capabilities and readiness. Our structured approach assesses your current AI capabilities, identifies gaps, creates a roadmap for improvement, and fortifies you with a robust AI governance framework to align AI initiatives with ethical, regulatory, and operational standards.

Download the white paper

Demonstrate Value with Quick-Start AI Proof of Concept

The acceleration of AI in life sciences propels companies to address business problems effectively with an AI proof of concept (PoC). We guide your organization in defining business goals, assembling an expert team, and testing essential functionalities.

Read the case study

Optimize Your Life Science Data for AI Readiness

Improve data quality, governance, and compliance with comprehensive data management and data science solutions that capitalize on advanced analytics, AI, and machine learning. Our artificial intelligence solutions help your organization derive actionable insights, streamline operations, and enhance decision-making with predictive analytics, while ensuring data integrity and adherence to regulatory standards like GDPR and CCPA.

Download the white paper

Unlock AI Innovation with Confidence

USDM’s AI Assurance framework ensures compliant, scalable, and risk-mitigated AI adoption through structured governance, validation, and operational oversight. Our three-phase approach—Learn, Control, Expand—helps organizations move from AI experimentation to enterprise-wide adoption while maintaining regulatory compliance and data integrity. Whether automating workflows, validating AI models, or ensuring governance, USDM provides the expertise to accelerate AI innovation safely and strategically. 

Download our AI Assurance Datasheet

AI Training for Life Sciences

Artificial Intelligence is transforming the life sciences industry—and your team needs to be ready. From accelerating clinical insights to enhancing quality operations and regulatory compliance, AI is unlocking new levels of productivity, innovation, AI-driven insights and AI model optimization. But with powerful technology comes responsibility. That’s why USDM offers customized, compliance-focused AI training designed specifically for regulated life sciences environments

Watch these micro-learning videos to see our training in action.

Ensuring AI Transparency

One of the biggest AI challenges is ensuring data lineage and traceability—proving where data originates and maintaining its integrity. Watch this clip to hear from John Petrakis, Chief AI Officer at USDM to learn why this matters for AI-driven decision-making.

Experience the full webinar here.

Life Science Domain Expertise

Success Stories​

USDM’s AI-driven solution transformed the clinical trial data management process for this life sciences company by achieving faster, more cost-effective trials while enhancing collaboration across teams. Learn more.

Saved 1,500 hours annually
1 hrs
Accelerating trial timelines by 25%
1 %
Saved an estimated $200K annually in operational costs
$ 1 K

FAQs About GenAI & ML Enablement in Life Sciences

GenAI (Generative AI) and ML (Machine Learning) Enablement means strategically embedding intelligent technologies into life sciences ecosystems—across R&D, clinical, quality, regulatory, manufacturing, and commercial functions. USDM ensures these capabilities are compliant, contextualized, and value-driven, allowing organizations to unlock automation, insights, and innovation at scale.
USDM takes a “compliance-first, innovation-always” approach. Our deep GxP expertise ensures your AI initiatives align with FDA, EMA, and global regulatory frameworks. From AI-readiness assessments to model governance, audit trails, and bias monitoring, we make GenAI safe, scalable, and strategically impactful.

We implement AI governance frameworks that align with GxP, GAMP, ISO, and emerging AI-specific guidance. Our proprietary models include:

  • Explainable AI (XAI) protocols
  • Automated compliance monitoring
  • Lifecycle traceability
  • SOP-aligned model training and testing
    This ensures your AI remains auditable, interpretable, and always inspection-ready.

Real-world examples include:

  • Clinical: AI-driven patient matching, adaptive trial designs
  • Quality: Predictive quality control, automated CAPA triaging
  • Regulatory: GenAI for automated submission document drafts
  • Safety: Signal detection from real-world evidence and post-market data
  • Manufacturing: Predictive equipment maintenance, process optimization
    USDM aligns each use case with domain-specific compliance requirements.

We assess your current systems, data structures, and governance posture. Then we:

  • Clean and tag multimodal data
  • Establish metadata and data lineage
  • Build compliance-aligned pipelines
  • Design AI-enabled workflows across the enterprise
    This prepares your environment to safely integrate and scale GenAI and ML technologies.

USDM supports:

  • Proprietary models built in-house
  • Cloud-native ML models on platforms like AWS, Azure, GCP
  • Open-source models under compliant governance
  • GenAI platforms like GPT, Claude, Med-PaLM
    We help you select, validate, deploy, and govern the right models for your use case and risk level.

Yes—when implemented properly. USDM ensures GenAI models:

  • Have documented training data and usage boundaries
  • Operate under access controls and audit trails
  • Support human-in-the-loop validation
  • Comply with ALCOA+ and data integrity principles
    This turns GenAI into a compliant accelerator rather than a risk.

GenAI drastically reduces manual work in document generation, signal detection, quality investigations, and regulatory research. It enables:

  • Auto-drafting of SOPs, protocols, and validation deliverables
  • Natural language insights from unstructured data
  • Rapid summarization of safety reports and literature
    USDM’s enablement ensures these efficiencies are documented, repeatable, and validated.

We deploy bias detection, model drift monitoring, and auditability into every AI project. USDM’s frameworks track:

  • Source data composition
  • Model decision pathways
  • Outcomes versus expected behavior
    We flag anomalies and retrain models proactively—ensuring AI remains an asset, not a liability.

All of the above. We tailor delivery based on your business model:

  • Consulting: Strategy, pilots, regulatory gap assessments
  • Managed Services: Ongoing model monitoring, risk controls, GenAI operations
  • Staffing: AI-literate GxP professionals for embedded execution
    Every engagement drives measurable outcomes like reduced review time, faster cycle times, and AI-enabled compliance.

Resources that might interest you​

Let's discuss the potential of AI in your organization.

Contact USDM today