Koosh Insurance · Specialized Risk Solutions / Industries

    Life Sciences

    The clinical trial that produces an unexpected adverse event. The medical device that performs differently in real-world use than in the trial population. The pharmaceutical that gets pulled three years after launch over a side-effect signal. Life sciences operates under the longest-tail product liability exposure in commercial insurance, plus regulatory complexity that no other industry contends with at the same intensity.

    See what's covered

    Coverage

    What this coverage includes

    • Product liability with appropriate occurrence and aggregate limits — the central line and the longest-tail
    • Clinical trial liability for human subjects participating in trials, including bodily injury and protocol-related claims
    • General liability for premises, operations, and non-product exposures
    • Professional liability for clinical, regulatory, and consulting activities
    • Errors & omissions for technology and software products in life sciences
    • Cyber liability with HIPAA-specific coverage for clinical and patient data
    • Directors & officers with life-sciences-aware forms covering FDA enforcement and product liability triggers
    • Property with research-equipment and intellectual-property considerations
    • Recall coverage for products subject to FDA mandatory or voluntary recall

    Who Buys This

    Who typically buys this coverage

    • Pharmaceutical companies — branded, generic, and specialty
    • Medical device manufacturers — Class I, II, and III devices
    • Biotech and gene therapy companies in development and commercial stages
    • Diagnostic and lab equipment manufacturers and operators
    • Contract research organizations (CROs)
    • Contract manufacturing organizations (CMOs)
    • Digital health and health-tech companies with software and device components
    • Clinical trial sponsors, including academic medical centers running industry-funded research

    Why Koosh

    Why Koosh Insurance

    Life sciences is among the most specialized commercial classes and one where the wrong agent can leave gaps that don't surface for a decade. We work the specialty markets that actually serve life sciences and coordinate the lines that have to work together.

    Specialty market access — life sciences underwriters at carriers that work this class daily.

    Clinical trial structuring — IRB-compliant, jurisdiction-specific, phase-appropriate coverage.

    Long-tail product liability with disciplined retroactive-date management.

    D&O for life sciences — venture-funded and clinical-stage, then commercial-stage, then capital-event-ready.

    Cyber and HIPAA for clinical research — aware of clinical data sensitivity and trial-site complexity.

    International coordination — territory analysis and local-market placement where needed.

    FAQ

    Frequently asked questions

    Longer claim tail, higher individual claim values, and more complex causation analysis. Product injuries in pharma and medical devices often surface years after market launch, sometimes after major class actions or FDA actions. Retroactive date management and proper claims-made vs. occurrence selection matter more than in most lines.

    No. FDA approval establishes regulatory clearance to market — it doesn't preempt product liability claims in most circumstances. Some narrow preemption applies under specific Supreme Court doctrine for Class III PMA-approved devices, but most claims proceed regardless of FDA status.

    Coverage for participants in clinical trials, separate from general product liability. Required by IRBs, university partners, contract research organizations, and most international jurisdictions before enrollment can begin. Limits and structure vary by trial phase, geography, and patient population.

    Sometimes — many policies include worldwide territory but exclude or sub-limit specific countries. EU, UK, and other major jurisdictions have specific local insurance requirements that may need separate placement. We map this carefully for any sponsor running international trials.

    Clinical and patient data is among the most sensitive data categories. Trial sites, sponsors, and CROs all carry exposure, and breach response under HIPAA is expensive. Cyber coverage with healthcare and life-sciences-aware terms is essential.

    Yes, especially for companies running clinical trials or with products in late-stage development. The exposure exists from the first trial enrollment, and capital event readiness (D&O, run-off, M&A insurance) matters earlier than founders typically expect.

    Related

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    Public Entities & Social Services

    Government agencies, municipalities, fire departments, nonprofits.

    This page provides general information about Life Sciences insurance and is not a substitute for tailored advice from a licensed insurance broker. Coverage availability, terms, exclusions, and pricing depend on your specific business operations, location, claims history, and carrier underwriting. Contact a Koosh Insurance broker for a personalized consultation. Koosh Insurance — License #L135215.

    Get a quote for Life Sciences

    Talk to a licensed Koosh broker. We'll review your specific situation, source quotes from appropriate carriers, and walk you through the coverage that actually fits your business.

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