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A discovery platform or delivery-technology business may serve a sponsor without owning the drug candidate or study. Before signing a research agreement or supporting an FDA-regulated investigation under an IND, list who controls the candidate, performs each service, sponsors the study, and holds customer materials; ask the broker to compare those responsibilities with the proposed terms.[1][2]
Consider professional errors and omissions (E&O), cyber liability, general liability, commercial property, and tools, equipment and inland marine. Start with the coverages tied to your day-to-day operations, then use the situations and buying questions below to compare your options.
You sell discovery, screening, formulation, analytics, or delivery-design services under a customer contract.
Ask how the proposed professional-liability wording treats your actual research or development services and the commitments in the contract. Request the forms and exclusions for the specific services and liabilities you accept.[2]
Which services, deliverables, customer entities, and contract assumptions are included, and what exclusions apply to research results or intellectual-property disputes?
You receive sponsor data, trial records, or protected health information through a study or technology relationship.
NAIC describes first-party incident costs and third-party claims as different cyber questions. HHS guidance applies to ePHI relationships; map the data and counterparties before comparing terms.[3][4][5]
Which sponsor and study data, vendors, response expenses, and customer claims are addressed by the proposed terms?
You operate a wet lab, host sponsor visits, or send staff to a customer or study site.
NAIC describes general liability around certain third-party injury and property-damage risks. Compare those terms with your lab premises and customer-site work; do not treat them as research-service or product terms.[6][7]
Which lab locations, site visits, demonstrations, and customer-property exposures are described, and what exclusions or limits apply?
You lease lab space or acquire specialized instruments, prototypes, or customer-owned equipment.
List each lab location, its equipment, and any property owned by others. Compare the proposed schedule, valuation, covered causes, and exclusions with that setup.[7]
Which instruments, samples, prototypes, and customer-owned property are listed at each location, and what valuation and covered-cause terms apply?
You move sponsor compounds, samples, or test equipment between your lab, a partner, and a study site.
For property away from a fixed site or in transit, ask whether the proposed terms fit each item and trip. Confirm scheduled property, movement stages, and exclusions in the form.[7]
Which property, routes, handlers, packaging or temperature conditions, and loading or installation stages are addressed by the wording?
For an IND study, list what you deliver and what the sponsor owns: candidate materials, data, methods, equipment, and study decisions. Use the study design, procedures, and monitoring you handle to describe your role and contract obligations.[2]
Do not assume the business is the sponsor because it built the platform or delivery system. For an FDA-regulated investigation under an IND, FDA defines the sponsor by who submits the application in the circumstances it describes. Confirm the sponsor and each party’s duties before asking about terms.[1]
When wet-lab procedures, batch size, outside manufacturing, or shipments change, update your operations description for the quote. Ask the broker to compare the process, site, equipment, and materials with the proposed schedule and exclusions.[7]
If a customer’s compound or instrument leaves your site, ask which form addresses it while in your custody and during each transfer. A property limit for your lab does not explain how a trip or customer-owned item is treated.[7]
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Not necessarily. A discovery vendor may provide services while another party sponsors and controls a study. For an FDA-regulated investigation under an IND, confirm which party FDA identifies as the sponsor and each company’s role before comparing requested terms.[1]
Read the Full AnswerList each customer-owned item, its value, location, use, and planned transfers. Ask the broker to show whether the proposed property or inland-marine terms address the item while stored, used, or moved; a policy label alone does not answer that question.[7]
Read the Full AnswerIdentify who sponsors an investigational drug or biologic study before describing the startup’s role to a broker.
Use the planned study activities and responsibilities to describe services and contract obligations.
Review general property, movable property, and machinery topics; compare them with the actual proposed forms.
Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements.
Updated 2026-09-28. Editorial Policy
Get help buying coverage and managing renewals, with less paperwork for your team. Start with a free consultation.