• Product Liability (Clinical Trial / IMP) – protection against claims alleging harm caused by an investigational product you manufactured, packaged, labelled or handled.
• Clinical Trial Recall / Withdrawal Costs – support for retrieval, quarantine, disposal, relabelling, and urgent redistribution.
• Errors & Omissions / Professional Indemnity – cover for negligence allegations, documentation mistakes, and validation errors.
• Stock, WIP & Materials – protection for high-value clinical batches, comparator drugs, placebo materials, and packaging components.
• Cold Chain & Temperature Excursion – cover for refrigerated, frozen, or cryogenic logistics, including monitored transit where applicable.
• Product Contamination / Deterioration – protection against insured contamination events and spoilage.
• Business Interruption – protection when a loss event disrupts production capacity or delays trial supply commitments.
• Equipment Breakdown – specialist cover for filling lines, lyophilisers, isolators, HVAC, freezers, and temperature-controlled infrastructure.
• Cyber & Data Incidents – protection for digital risks affecting trial supply operations, randomisation systems, and sensitive sponsor data (optional).
• Regulatory Defence – support for legal costs arising from inspections, investigations, and regulator enquiries, subject to policy terms.

Trial timelines are unforgiving. If investigational product supply is delayed, cohorts can be cancelled, sites can stand down, and sponsors may incur knock-on costs. Many clinical supply contracts include tight SLAs, performance metrics, and penalties that become critical after a loss event.

• Short lead times for manufacturing and packaging runs
• Limited rework windows before dosing dates
• Perishable and short-dated materials
• High dependency on courier and depot networks

Clinical trial supply relies on complete, correct and auditable documentation — batch records, deviation reports, chain-of-custody logs, temperature histories, and regulatory labelling compliance. Even where physical stock is intact, missing documentation can prevent release and trigger re-manufacture.

• Batch record completeness and reconciliation
• Deviation handling and CAPA workflows
• QP certification and release scheduling
• Import/export documentation packs

An excursion during international shipping can trigger quarantine, stability assessment, and potential destruction of stock. Where doses are time-critical, sponsors may need emergency replacement manufacturing or expedited importation.

• Courier delay or handling failure
• Packaging configuration issues
• Sensor/monitoring disputes
• Depot storage deviation

Clinical aseptic manufacturing can be vulnerable to contamination events. A sterility failure can wipe out limited material and require re-manufacture, re-testing, and re-validation.

• Environmental monitoring failure
• HVAC disruption or pressure cascade issues
• Operator gowning breach
• Equipment cleaning validation issues

• Early-phase and late-phase IMP manufacturing
• Aseptic filling and sterile finishing
• Formulation, compounding and scale-up
• Analytical testing and stability studies
• QP release coordination

Advanced therapies can involve cryogenic temperatures, patient-specific materials, and highly controlled chain-of-identity / chain-of-custody workflows. We can help align cover to the realities of ATMP logistics and manufacturing dependencies.

• Cryogenic storage and monitored shipment
• Patient-specific material handling
• Contingency planning and emergency rerouting
• Facility and freezer breakdown exposures

• Life Sciences Expertise – we understand IMP workflows, QP release, cold chain risk, and sponsor contract requirements.
• Market Access – we compare options from leading insurers to match limits and policy wording to your real exposures.
• Fast, Practical Guidance – we focus on what underwriters need and how to present your risk clearly.
• Contract-Ready Cover – support for sponsor/partner insurance requirements and evidence of insurance.
• Claims Support – responsive guidance when an incident threatens trial timelines and sponsor relationships.

• 1. Share Your Operations – manufacturing activities, packaging scope, depots, territories, and clinical phases supported.
• 2. Review Key Exposures – batch values, cold chain reliance, sponsor contract limits, and release processes.
• 3. Compare Quotes – we approach suitable insurers and present options clearly.
• 4. Tailor the Policy – add required extensions such as worldwide jurisdictions, transit, deterioration, and recall costs.
• 5. Put Cover in Place – receive documentation and ongoing support as you scale.

• Clinical trial product liability exposures
• Costs of withdrawal, quarantine and rework
• Cold chain failures and stock deterioration
• Equipment breakdown impacting capacity
• Business interruption and increased cost of working
• Regulatory defence and investigation support (where available)

• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Clinical Trial Regulations and sponsor quality agreements
• Pharmacovigilance reporting expectations
• Data protection and confidentiality obligations
• Import/export and controlled temperature shipment requirements