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Mid-market insurance
Contract research organisation insurance is the programme of professional indemnity, property, liability and cyber cover protecting firms that run studies for pharma and biotech sponsors. It matters because one flawed study can cost a sponsor years.
Part of: Medical technology insurance
In short
CROs running pre-clinical and laboratory work usually need professional indemnity as the core cover, with laboratory property and business interruption, cover for sponsor samples in their care, liability, employers' liability, cyber and management liability. Clinical trials insurance is a separate cover. GLP studies can be disqualified after MHRA monitoring findings, and the MHRA inspectorate expects non-NHS phase 1 sites to check sponsor trial insurance themselves rather than rely on the ethics committee. Contract caps and indemnities usually decide how much of a sponsor's loss falls on you.
A UK contract research organisation (CRO) running pre-clinical, bioanalytical or laboratory studies for pharma and biotech sponsors usually needs professional indemnity (errors and omissions) as its core cover, supported by laboratory property and business interruption, cover for sponsor samples and materials in your care, public and products liability, employers' liability, cyber and management liability. If you run or host human studies, clinical trials insurance is a separate question.
The CRO's real product is reliable data. When a study fails, the sponsor's loss is rarely physical: it is the cost of repeating work, a delayed regulatory submission or a programme decision built on flawed results. That is professional liability territory, and our guide to PI for clinical and scientific researchers explains how those wordings work.
How common CRO exposures usually map to cover, subject to the policy terms:
| Exposure | Cover that usually responds | Points to check |
|---|---|---|
| Protocol deviation or data error makes a study unusable | Professional indemnity (E&O) | Whether the cost of re-running studies is covered or treated as a contractual remedy |
| Study loses its GLP status after an inspection finding | Professional indemnity | Regulatory investigation costs and exclusions for fines |
| Freezer failure destroys sponsor samples or test articles | Property (goods in trust or custody) with deterioration extension | Valuation basis for samples that cannot be replaced |
| Fire or flood closes the laboratory | Property and business interruption | Increased cost of working to move studies to partner labs |
| Injury to a trial participant at a clinical unit | Clinical trials insurance (sponsor and site) | Who insures what under the trial agreement |
| Visitor or contractor injured on site | Public liability | Limits required by sponsor and landlord contracts |
| Staff exposure to biological agents or solvents | Employers' liability | COSHH assessments and health surveillance |
| Ransomware or audit trail corruption in LIMS or eCRF systems | Cyber | Data restoration, business interruption, and regulator notification |
| Claims against directors after a failed study or funding dispute | Management liability or D&O | Investigation cover and contractual liability exclusions |
Three regimes shape most CRO programmes.
Regulatory non-clinical safety studies must follow GLP under the Good Laboratory Practice Regulations 1999. The MHRA hosts the UK GLP Monitoring Authority, which inspects member facilities every 12 to 30 months and, following serious concerns, can suspend membership or disqualify the GLP status of specific studies. A disqualified study can be worthless to the sponsor, which is exactly the kind of loss a sponsor may try to recover from you.
The Medicines for Human Use (Clinical Trials) Regulations 2004 have long required that provision be made for insurance or indemnity to cover the liability of the investigator and sponsor, and the amended rules in force from 28 April 2026 still call for evidence of insurance or a similar arrangement. The MHRA inspectorate has noted that some CROs and phase 1 units assumed the research ethics committee had checked the sponsor's insurance was suitable; the committee confirms cover exists but does not assess its suitability. The inspectorate expects non-NHS sites to check the sponsor's cover for each trial, including at renewal, and to file the record.
Storing human tissue for research in England, Wales and Northern Ireland can need a Human Tissue Authority licence unless an exemption applies, such as an ethics-approved specific project. Personal data from participants brings duties to the Information Commission (formerly the ICO).
Illustrative. A bioanalytical lab uses an incorrectly validated method across a toxicology study. The sponsor discovers the issue during regulatory review and demands the cost of repeating the study plus programme delay. PI usually responds to the negligence claim; the sponsor's lost profits may be limited by the contract's liability cap.
Illustrative. A power outage overnight warms a -80°C freezer holding a sponsor's patient-derived samples. The samples belong to the sponsor, so cover depends on whether the CRO's property policy extends to goods in its custody and includes deterioration.
Illustrative. A master services agreement asks the CRO to indemnify the sponsor for "any loss" from its services, uncapped. The PI policy covers legal liability for negligence, not every loss a contract could create. See how PI treats contractual liability.
Underwriters usually want to understand the work, the contracts and the controls. Helpful information includes:
Plan a fuller insurance programme review when:
Related: medical technology insurance, life sciences and biotech insurance, medtech company insurance and drug discovery company insurance. Apex arranges insurance for contract research organisations; a broker reads every enquiry.
Usually professional indemnity as the core cover, with laboratory property and business interruption, cover for sponsor materials in your care, public and products liability, employers' liability, cyber and management liability. Clinical trials insurance is separate and depends on whether you act as sponsor, site or service provider.
No. Clinical trials insurance responds to injury to participants arising from a trial and is usually arranged by the sponsor, with sites covering their own conduct. Professional indemnity responds to claims that your services were negligent, such as a data error that forces a sponsor to repeat work.
According to the MHRA inspectorate, the research ethics committee confirms that insurance exists but does not assess whether it is suitable. Non-NHS phase 1 sites, including CROs, are expected to check the sponsor's cover for each trial, look for inappropriate exclusions, and record that check.
Not automatically. Samples and test articles usually belong to the sponsor, so you need cover for goods in your custody, and a deterioration extension for loss from freezer or power failure. Agree how irreplaceable samples are valued in the contract before a loss happens.
It can. If a study is disqualified because of failings in your conduct, the sponsor may claim the cost of repeating it and associated delay. Professional indemnity usually responds to negligence claims, subject to the policy terms, but contractual caps and exclusions often decide how much is recoverable.
Send us your current schedules or renewal pack and we will review the whole programme and tell you plainly what to keep and what to change. No fee and no obligation. Or call 0117 325 0027.
Book a programme review Get a quoteApex Insurance Brokers Limited is authorised and regulated by the Financial Conduct Authority. Registered in England and Wales, company number 07014570. This page is general information, not advice on your individual circumstances, and it does not guarantee that cover will be available or on what terms.
