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NOVO Industries · Biotech & Research

Biotech and research organizations protecting research IP and accelerating R&D with secure AI.

From biotech firms protecting research IP under HIPAA and GxP frameworks to research organizations operating under CMMC and GCC requirements for defense-funded research, life sciences customers face regulatory pressure that most engagements meet by stitching together multiple vendors. NOVO's approach is structurally different: research IP protection, regulatory framework alignment, R&D operations, and AI delivery integrated end-to-end on the Microsoft platform — Azure regulated workloads for research compute, Microsoft 365 with life-sciences-aligned tenant configurations, and Compass-delivered AI agents that respect IP and operate inside the framework's documented controls.

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The NOVO difference

Sensitive data protection. Organized R&D operations. AI-accelerated research workflows. Three pillars on a single Microsoft platform — instead of stitching together multiple compliance vendors, ERP systems, and AI tooling providers.

Biotech & Research frameworks

  • HIPAA
  • GxP
  • 21 CFR Part 11
  • GCP
  • GLP
  • IRB compliance
  • Research IP protection
  • CMMC
  • GCC environment

The Biotech & Research reality

The context behind "we serve life sciences."

Biotech and research customers operate under regulatory frameworks, operational realities, and Microsoft platform requirements that most technology services don't understand. NOVO's vertical depth is concrete in three specific directions — the regulatory framework reality (which frameworks apply, which controls map, which Microsoft platform configurations satisfy them), the R&D operational reality (research IP protection, document governance for regulatory records, sprint-driven delivery for evolving research priorities), and the AI delivery work that's reshaping how research happens.

Block 1 · The regulatory framework reality

Biotech and research customers operate under multiple overlapping frameworks. NOVO knows which apply to which customer.

HIPAA establishes patient data protection requirements that apply across pharmaceutical research, biotech firms handling protected health information, clinical research organizations, and medical device firms whose products generate or store patient data. GxP is the umbrella for regulated practice frameworks — Good Clinical Practice (GCP) for clinical trial conduct, Good Laboratory Practice (GLP) for non-clinical research, Good Manufacturing Practice (GMP) for pharmaceutical and biologic manufacturing. 21 CFR Part 11 specifies the FDA's electronic records and electronic signatures requirements. IRB compliance governs research involving human subjects across academic medical centers, contract research organizations, and biotech firms running clinical research.

And a subset of biotech and research customers operate under additional CMMC and GCC requirements — particularly defense-funded research organizations, biotech firms working on biodefense or DARPA-funded programs, and research institutions whose grant relationships flow CMMC obligations into their operational reality. NOVO's vertical depth means understanding of how these frameworks interact, which controls apply to which customer's specific contractual and regulatory reality, and how to scope the regulatory environment efficiently.

Block 2 · Research IP protection and R&D operational reality

Research IP, regulatory records, and R&D operations have specific protection and governance requirements that most operational tooling doesn't address.

Research IP — the intellectual property at the heart of biotech and research operations — is the asset that drives company valuation, competitive positioning, and long-term commercial outcomes. Research IP must be protected against external threat actors targeting biotech for industrial or nation-state espionage, against insider threat patterns specific to research environments, against accidental exposure through poorly-governed document workflows, and against systematic exfiltration through tools that don't integrate with the regulatory environment.

R&D operations have their own reality. Research priorities evolve faster than annual planning cycles. Project execution requires sprint-driven delivery rather than waterfall project management. Document governance for regulatory records (lab notebooks, study reports, audit trails) must satisfy framework requirements while remaining operationally usable. Most biotech firms face an operational decision: full-suite ERP procurement (substantial cost, substantial implementation timeline) or Microsoft-native operational stacks built on SharePoint, Teams, and Power Platform that replace ERP functionality for biotech-scale operations.

Block 3 · The Microsoft platform configuration for biotech and research

The Microsoft platform fits biotech and research through specific configurations. NOVO deploys, operates, and supports them across the Biotech & Research practice.

The Microsoft platform fits biotech and research through configurations that vary by regulatory regime. For HIPAA-covered customers, the configuration is commercial Azure with HIPAA Business Associate Agreement plus Microsoft 365 with HIPAA-compliant tenant configuration — Azure regulated workloads for research compute, Purview for sensitive-data classification across research IP and patient data, Defender suite calibrated for life-sciences threat patterns, Compliance Manager mapped to HIPAA controls. For biotech customers operating under CMMC + GCC for defense-funded research, the configuration shifts to Microsoft 365 GCC tenant plus G5 Security and Compliance plus Azure Government — the same CMMC baseline tenant NOVO deploys for Defense Industrial Base customers, calibrated to research-environment use cases.

And the AI delivery work runs on the same platform. Azure AI Foundry hosts biomedical models (BioGPT, PubMedBERT) for research workflows. Microsoft 365 Copilot agents (Researcher, Analyst) operate inside GCC-controlled environments for biotech customers under CMMC. RAG-augmented research workflows compress prior-art and experimental synthesis work that previously consumed senior-scientist weeks into structured workflows. NOVO's Compass delivers AI agents that respect research IP, operate inside the framework's documented controls, and integrate with the operational stack rather than running as standalone AI tooling.

How NOVO delivers for Biotech & Research

Cross-portfolio NOVO services — calibrated to research IP protection, R&D operations, and secure AI delivery.

Biotech and research customers engage NOVO across three layers: the foundational layer (License, Cloud, Care) that runs across every NOVO engagement, the strategic entry point (Compass) that delivers the AI work and R&D process organization, and the vertical specialty (Compliance) that delivers the regulatory framework alignment. The heart of biotech engagements typically sits in Compass — where AI delivery, R&D operations organization, and secure AI agent development converge into one engagement model.

Foundational layer · License → Cloud → Care

  • Foundational · License

    NOVO License

    Microsoft 365 with HIPAA-compliant tenant licensing for HIPAA-covered customers; M365 GCC + G5 licensing for biotech customers operating under CMMC + GCC for defense-funded research. Azure regulated workloads licensing for research compute environments. Microsoft Direct CSP relationship that typically produces immediate licensing discount opportunities biotech customers can verify against current invoices. License optimization analysis surfaces consolidation opportunities — Microsoft licensing replacing third-party compliance tools, research data integrity platforms, and document control systems.

  • Foundational · Cloud

    NOVO Cloud

    Biotech platform deployment — research IP protection, regulatory framework alignment, and R&D operational stack as a single coherent deployment. Azure regulated workloads deployment for research compute. Microsoft 365 tenant deployment with life-sciences-aligned configuration (HIPAA-compliant commercial tenant for most biotech customers, GCC for CMMC-pressured customers). Purview, Defender, and Compliance Manager configuration mapped to the customer's specific regulatory framework set. Microsoft-native operational stack deployment — SharePoint architecture for document governance, Teams for research collaboration, Power Platform for procurement workflows and project execution that replace full-suite ERP for biotech-scale operations.

  • Foundational · Care

    NOVO Care

    End-to-end operational support across the deployed Microsoft platform configuration. Care package selection calibrated to the customer's regulatory regime: Platinum Level 1-2-3 coverage for biotech customers under CMMC (matching the Defense Industrial Base requirement); Gold or Silver for HIPAA-aligned biotech customers based on operational reality. AI-augmented operations across the Care service portfolio. Operational continuity inside the framework's documented controls — research IP protection and regulatory compliance posture maintained as part of day-to-day operational reality.

Where many engagements start · NOVO Compass

Strategic entry point · Compass

NOVO Compass — secure AI delivery, R&D process organization, and AI advisory for research environments.

The heart of many biotech and research engagements. Compass delivers AI agent development that respects research IP and operates inside framework-controlled environments — research agents for prior-art compression and experimental synthesis, biomedical models on Azure AI Foundry (BioGPT, PubMedBERT), Microsoft 365 Copilot agents (Researcher, Analyst) operating inside GCC for CMMC-pressured customers, RAG-augmented research workflows that integrate with the customer's research data corpus. Compass also delivers R&D process organization — operational systems for project execution, document governance, procurement workflows, and sprint-driven delivery built on the Microsoft-native operational stack (SharePoint, Teams, Power Platform). And Compass delivers AI advisory and strategic technology services — process discovery for “as-is” research workflows, prioritized AI/automation roadmaps, ontology and knowledge graph foundations for longer-term “research brain” architectures.

Biotech & Research specialty · Compliance

  • Vertical specialty · Compliance

    NOVO Compliance — regulatory framework alignment for biotech and research customers.

    The framework-specific moment. Control implementation mapped to HIPAA, GxP, 21 CFR Part 11, GCP, GLP, GMP, IRB compliance, or CMMC (depending on the customer's regulatory regime) — control implementation, not checkbox documentation. Evidence accumulation — operational records that become audit evidence when assessment time arrives, accumulated through the Microsoft platform's native compliance tooling. Audit support — gap analysis, pre-assessment readiness, audit-week support with the Compliance team operating alongside customer responses for FDA submissions, HIPAA audits, GxP inspections, and CMMC assessments. Research IP protection programs — substantive IP-protection posture documentation supporting both regulatory compliance and patent-defense use cases. AI-augmented compliance operations across the entire engagement.

The services work together as one integrated Biotech & Research engagement — License procures the licensing that supports the regulatory regime, Cloud builds the biotech platform configuration, Care operates it day-to-day with regulatory-appropriate coverage, Compass delivers the AI work and R&D process organization, and Compliance certifies it against the customer's specific framework set. The Biotech & Research reality is one integrated engagement, not five separate vendor relationships.

Biotech & Research in the NOVO portfolio

The full integrated technology partner — calibrated to research IP, R&D operations, and secure AI.

Biotech and research customers don't engage NOVO for “HIPAA compliance” or “AI advisory” or “research operations” as discrete deliverables. They engage NOVO as the integrated technology partner that handles the platform deployment, the operational managed services, the regulatory framework alignment, the AI delivery, and the R&D process organization as one coherent engagement.

A typical Biotech & Research engagement flows across the portfolio

  • License procures
  • Cloud builds
  • Compass delivers (AI + ops)
  • Care operates
  • Compliance certifies

Customers engaging across multiple services experience the architecture as one integrated relationship rather than as five separate engagements. The licensing strategy (License) determines the platform configuration; the platform deployment (Cloud) gets operated day-to-day (Care); the AI delivery and R&D process work (Compass) runs on the same platform Cloud deployed and Care operates; the compliance posture (Compliance) accumulates evidence from the operational reality. Research IP protected, R&D operations organized, AI delivered securely, regulatory frameworks satisfied — same coverage, fewer vendors, end-to-end ownership of the customer's biotech and research reality.

Ready when you are

The fastest way to know what NOVO can deliver for your Biotech & Research reality is to start a conversation.

Tell us about your Biotech & Research situation — the biotech firm preparing for HIPAA-covered-entity audit while organizing R&D operations across distributed research teams, the research organization protecting research IP under federal grant compliance and pursuing patent-supporting AI workflows, the medical device firm aligning systems with 21 CFR Part 11 and ISO 13485, the clinical research organization building secure AI agents for prior art compression and trial data analysis, the biotech firm with defense-funded research operating under CMMC + GCC requirements you weren't planning for. Whether your priority is research IP protection, regulatory framework alignment, R&D process organization, AI-accelerated research workflows, or all of the above, we'll talk through what makes sense for your specific reality.

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