Clinical trials insurance: CRO & Sponsor Risk Guide

Essential clinical trials insurance for trial sponsors, CROs and organisations conducting clinical research in the UK.

Short answer: Clinical trials insurance UK programmes protect sponsors and CROs from participant injury claims, regulatory compliance failures and operational disruptions. For CTIMP trials, insurers expect documented MHRA approvals, active safety monitoring and clear liability allocation between sponsors, CROs and sites.

But here’s what trial sponsors often miss: insurance isn’t a box ticking exercise you complete once before MHRA submission. It’s the mechanism that keeps trials fundable when incidents occur, contracts negotiable with sites and CROs, and regulatory relationships intact when something goes wrong. The practical difference between a well insured trial and an underinsured one becomes visible at three moments: when you’re contracting with a new CRO, when investors ask about your safety record during fundraising, and when a serious adverse event forces you to explain your response plan to regulators.

Picture this: you’re a biotech founder three weeks from submitting your Phase II MHRA application. The ethics committee has one remaining question about your insurance documentation. You open a folder and find clear certificates, a documented delegation matrix showing who carries which risks, and evidence that your CMO’s contamination cover aligns with your own participant injury policy. You answer the question in one email. The application proceeds on schedule.

That’s what proper clinical trials insurance looks like in practice.

Who Actually Carries Liability in Clinical Trials

If you’re a trial sponsor working with CROs, manufacturing partners and clinical sites, the question “who is liable” has three separate answers: legal liability, contractual liability and practical liability. Understanding the difference keeps your programme insurable.

Legally, the sponsor holds primary responsibility. Regulators and courts start from this position. You designed the protocol, you oversee safety monitoring, you hold the regulatory approvals. That doesn’t change even when you delegate operational work to others.

Contractually, liability is negotiated. When you engage a CRO to run trial operations, you typically negotiate indemnities: the CRO accepts responsibility for their negligent execution, you retain responsibility for protocol design. When you contract with manufacturing partners for investigational product supply, they accept contamination risk for batches they control.

Practically, liability follows control. If a site fails to obtain proper informed consent, that’s a site failure. If your CMO ships contaminated product, that’s a manufacturing failure. If your protocol design creates unreasonable risk, that’s a sponsor failure.

The insurance consequence: allocate risk to parties who can control and insure it. Your CRO should carry professional indemnity and operational liability cover for their monitoring and data management. Your CMO should carry product liability for contamination. You should carry sponsor legal liability for protocol design decisions and participant injury cover for trial related harm.

Underwriters want to see this allocation documented. A delegation of duties matrix showing who does what, backed by insurance certificates from each party, reduces underwriting friction and keeps your programme competitive.

What Insurance Programme Do You Actually Need

There is no single clinical trials insurance policy that solves every exposure. The typical programme is layered, with each element protecting specific risks.

Clinical trials insurance covers liability to participants for injury or death arising from the trial. For CTIMPs (trials involving medicinal products), insurers expect full regulatory compliance, documented safety monitoring and clear adverse event reporting procedures. This is the foundational cover that MHRA and ethics committees expect to see.

Sponsor legal liability is broader than participant injury. It covers claims arising from protocol design failures, inadequate informed consent processes, or regulatory compliance lapses that harm trial integrity. Think of it as professional indemnity for the sponsor role.

CRO insurance addresses operational delivery. Data management errors, monitoring lapses, site oversight failures and local negligence fall here. Your CRO should carry professional indemnity cover with limits proportionate to the trial value and participant numbers.

Product liability becomes relevant when your investigational product causes harm outside the controlled trial context, or after you receive marketing authorisation and historical trial exposure creates claims. This is separate from participant injury cover during the trial.

First party covers protect your own assets. Business interruption cover responds if a manufacturing failure stops your trial. Contingent business interruption covers supplier failures that prevent trial continuity. Property cover protects investigational product inventory and equipment.

Cyber and data breach cover addresses loss of participant data or compromise of trial data integrity. Regulators scrutinise data protection controls, and breaches can invalidate trial results.

Recall and contamination cover responds when investigational product batches fail quality controls or when field performance reveals previously undetected risks requiring batch recalls.

According to the Health Research Authority, sponsors must demonstrate adequate insurance arrangements before trials can commence. Underwriters view the programme holistically: they want to see aligned responsibilities between sponsor and CRO, consistent evidence trails showing who controls each risk, and proportionate limits for the trial phase and participant numbers.

How CTIMP Insurance Differs From Non-CTIMP and Device Trials

If you’re running trials involving medicinal products (CTIMPs), medical devices, or non interventional studies, the insurance underwriting differs significantly. Understanding why helps you prepare the right documentation.

CTIMPs sit in the strictest regulatory frame. The UK Clinical Trials Regulations and MHRA oversight require explicit regulatory approvals before you dose the first participant. Insurers expect documented proof of those approvals, active Data Safety Monitoring Board oversight, and clear serious adverse event reporting timelines. The underwriting process mirrors regulatory scrutiny: detailed, evidence based, and focused on safety governance.

Non CTIMP trials (observational studies, some early phase device work, nutritional interventions) carry different risk profiles. There’s still participant exposure, but the regulatory requirements and safety monitoring intensity differ. Underwriters adjust their evidence requirements accordingly: less emphasis on MHRA approvals, more focus on protocol risk assessment and local ethics approval.

Device trials introduce mechanical failure, software faults and human factors that don’t appear in drug trials. A cardiac monitoring device with firmware errors creates different liability than a biologic with unexpected immunogenicity. Underwriters probe device design controls, pre-market validation testing, and any field performance history from similar devices. If your device failed in previous deployments, expect that history to affect pricing and terms.

The practical consequence for you: if you run both drug and device trials, or if you mix CTIMP and non CTIMP work, structure your insurance programme to address each separately. Trying to force everything into a single broad policy usually creates coverage gaps or inflates premium for low risk work.

What Underwriters Ask For When You Place or Renew Clinical Trials Insurance

Underwriters are pricing risk and managing their portfolio exposure. Their questions reveal what actually matters to achieving competitive terms.

They’ll request your trial protocols and any amendments. They’re looking for dose escalation schemes, participant inclusion criteria, and how you’re managing known risks. If your Phase I protocol shows aggressive dose escalation without clear stopping rules, expect questions.

Investigator brochures and informed consent forms come next. Underwriters want to see that participants understand what they’re consenting to, and that you’ve disclosed known risks honestly. Vague or incomplete disclosure raises red flags.

Safety monitoring plans and DSMB charters show governance. How quickly do you detect and respond to serious adverse events? Who makes the call to pause or stop a trial? Underwriters want to see active oversight, not reactive crisis management.

SAE logs and line by line summaries of prior incidents matter immensely. If you’ve run trials before, underwriters will probe your incident history. A well managed SAE with clear root cause analysis and corrective actions demonstrates competence. Concealed incidents discovered during underwriting destroy trust and pricing.

The delegation of duties matrix shows who does what. Underwriters want to see that your CRO, sites, manufacturers and logistics providers have clear responsibilities matched to insurance obligations. Vague delegation creates gaps where no one is clearly accountable.

Contracts with CROs, sites, manufacturers and logistics providers reveal risk transfer. Underwriters read indemnity clauses, insurance requirements, and cooperation obligations. Open ended indemnities or unlimited liability promises create issues.

Evidence of vendor insurance is non negotiable. If your CMO carries your contamination risk, underwriters need to see current certificates showing adequate limits and appropriate policy wording. Missing vendor insurance means you’re retaining risks you thought you’d transferred.

According to MHRA guidance, sponsors must maintain comprehensive records of trial conduct and safety monitoring. Regulatory correspondence and inspection history give underwriters confidence that you manage regulatory relationships professionally. A history of findings that were promptly corrected is better than pretending inspections never happened.

Data integrity controls and backup procedures matter more now than five years ago. Cyber risk and ransomware have made trial data a target. Underwriters want to see that you can recover from data loss without invalidating trial integrity.

The practical approach: prepare a concise, indexed insurance submission pack. Use a single PDF with clear section markers and a contents page. You control the narrative by supplying organised evidence, not by overwhelming underwriters with unsorted documents.

How Contracts Should Allocate Risk and Insurance Between Sponsors, CROs and Sites

Contracts are where risk allocation becomes binding. Good contract drafting preserves insurability, maintains negotiability with counterparties, and creates clear lines of accountability when something goes wrong.

Allocate risk to the party that controls it. Don’t force a small clinical site to insure protocol design defects they have no power to prevent. Don’t expect your CRO to cover manufacturing contamination they don’t control. Match accountability to actual authority and control.

Be specific about insurance types, limits and evidence. Vague requirements like “adequate insurance” create disputes. State the required covers explicitly: “CRO shall maintain professional indemnity insurance with minimum limits of £5 million per claim and in the aggregate, with certificates naming Sponsor as an interested party.”

Avoid open ended indemnities. Unlimited indemnity obligations are red flags for underwriters and commercial buyers. They make your programme harder to insure and reduce negotiability. Use indemnities tied to proven negligence or breach of specific obligations instead.

Use proportional indemnities where multiple parties contribute to a failure. If both sponsor protocol design and CRO execution failures combine to cause harm, a proportional indemnity structure (each party liable for their contribution) is more realistic than joint and several liability.

Address subrogation and recovery explicitly. Some insurance policies limit an insurer’s right to pursue third parties for recovery. If your policy includes subrogation waivers in favour of certain parties, your contracts need to acknowledge that. Otherwise you create conflicts between contractual obligations and policy terms.

Include cooperation clauses for claims handling. Define notification timelines, evidence preservation requirements, and cooperation obligations when claims arise. Specify that parties must assist with regulatory investigations and insurer inquiries.

What underwriters actively dislike: blanket indemnities requiring one party to “indemnify for any loss” regardless of fault. These clauses either increase premium significantly or lead to policy carve outs that undermine the risk transfer you thought you’d achieved.

What Actually Happens When a Serious Adverse Event Occurs

When a serious adverse event happens, you have access to clinical safety experts, forensic laboratories, regulatory lawyers and crisis communications specialists. These are people who’ve handled hundreds of incidents and can advise on every decision. You stay in control, you make the calls, but you make them with experienced support standing behind you.

Preserve evidence immediately. Stop the chain of custody from breaking. Retain biological samples, device components, drug vials, cold chain telemetry logs, and any equipment involved. Evidence that’s lost or contaminated cannot support your position with regulators or in claims defence.

Notify insurers promptly. Policy terms typically require notification “as soon as reasonably practicable” after you become aware of circumstances that may give rise to a claim. Late notification can prejudice cover. Notify with facts you know, not speculation about liability or causation.

Notify regulators within statutory timelines. MHRA requires serious adverse event reporting within specified timelines depending on event severity and expectedness. Your regulatory reporting obligations are separate from insurance notification and run on their own schedule. Follow both timelines.

Assemble your response team. Clinical safety lead, regulatory affairs, legal counsel, your CRO operations lead, and a named contact at your insurer. Everyone needs to know their role and information flow protocols before an incident, not during one.

Document every decision. Record who decided what, when, and based on what information. Regulators and insurers will reconstruct your decision process later. A clear decision trail showing you acted on the information available at the time protects you from hindsight bias.

Communicate carefully with external parties. Public statements, participant communications and regulatory correspondence should be factual, coordinated with legal and regulatory advice, and avoid speculation about causation or liability before investigation concludes.

Insurers will investigate. They’ll ask for root cause analysis, corrective and preventive actions, and evidence of steps to prevent recurrence. This is normal claims management, not an adversarial process. They’re supporting your defence and managing their exposure. You haven’t lost control, you’ve gained expert resources to make defensible choices under pressure.

Scenario: Contamination at a Phase II Site

A Phase II biologics trial discovers a cluster of unexpected local reactions at one site. When you investigate, microbiological testing reveals contamination in investigational product vials from a specific batch.

Immediate containment. The site stops dosing immediately and quarantines all remaining vials from the suspect batch. This limits further participant exposure and preserves physical evidence for investigation.

Rapid notification. You notify MHRA within required timelines, inform your DSMB, and notify your clinical trials insurance carrier and your CMO’s product liability insurer within 24 hours. Multiple policies may respond, and early notification protects coverage under all of them.

Traceability investigation. You run batch records, cold chain telemetry data, and chain of custody logs for the contaminated batch. Telemetry data shows a six hour temperature excursion during distribution from your CMO to the clinical site. That excursion violated storage specifications.

Root cause and corrective action. Your CMO conducts root cause analysis and identifies a failed seal at the fill line during manufacturing. They halt production, quarantine related batches, and initiate a voluntary recall of distributed but unused vials. They document corrective actions to prevent recurrence.

Claims handling. Participants who developed reactions initiate claims. Your clinical trials insurance and your CMO’s product liability policy both engage. The CRO’s monitoring records are examined to determine whether their site oversight detected any warning signs before the cluster emerged.

Regulatory response. MHRA opens an inspection focused on your batch release procedures and your CMO’s manufacturing controls. Your documented rapid response, immediate containment, and clear corrective actions reduce the likelihood of enforcement action. You demonstrate that you acted proportionately when you discovered the problem.

Commercial consequence. Six months later, during Series B due diligence, investors request your incident history. You provide a concise pack: SAE summaries, root cause analysis, cold chain telemetry data, corrective action reports, MHRA correspondence, and confirmation that all claims resolved within policy limits. The investor sees competent incident management, not concealment or chaos.

This is why evidence preservation and rapid response matter. You control the narrative with documentation. You show regulators and insurers that you acted appropriately given what you knew when you knew it. That supports regulatory relationships, claims defence, and commercial credibility.

How Clinical Trials Insurance Affects Fundraising and M&A Due Diligence

Insurance is either a deal enabler or a deal blocker. Investors and acquirers want to see that clinical risk is understood, insured and disclosed appropriately.

What investors expect to see:

Current insurance certificates showing cover is in force, with limits and policy periods clearly stated.

Policy wordings or summaries explaining what is and isn’t covered. Investors want to understand exclusions and sublimits that might create exposure.

Claims history with outcomes and current reserves. A history of well managed claims with documented outcomes demonstrates operational maturity. Concealed claims discovered during due diligence raise questions about what else you’re hiding.

Trial protocols, safety monitoring plans and DSMB minutes showing governance. Investors assess trial risk by examining your safety oversight, not just your protocol.

Contracts with CROs, CMOs and logistics providers, including their insurance obligations. Investors want to see that you haven’t silently outsourced uninsured risk to undercapitalised vendors.

Regulatory correspondence and inspection history. MHRA findings, responses and close out letters give investors confidence that you manage regulatory relationships professionally.

Practical advice for sponsors:

Prepare your due diligence pack before you need it. Index it. Organise documents so investors can find answers quickly. You control the pace of due diligence by being prepared.

Be transparent about past incidents. A disclosed, well managed serious adverse event with clear documentation is infinitely better than an incident discovered through regulatory freedom of information requests during investor background checks.

Ensure vendor insurance aligns with your deal narrative. If you tell investors your CMO carries contamination risk, their insurance certificate must support that claim. Gaps between your representations and vendor insurance create doubt.

Underwriters and investors both probe aggregation risk. A single manufacturing failure affecting multiple trial sites or multiple trials from one batch creates aggregation exposure. Be ready to explain how you model aggregation and whether your policy includes appropriate aggregation clauses.

What Reduces Underwriting Friction and What Creates It

Underwriters are practical. They dislike uncertainty and poor documentation because both make risk pricing difficult.

Common friction points:

Vague delegation matrices that don’t clearly assign responsibilities.

Missing serious adverse event logs or inconsistent reporting between what you tell regulators and what you tell insurers.

Contracts with unlimited indemnities that your insurance doesn’t support.

Lack of vendor insurance evidence when you claim risks are transferred.

Poor telemetry or missing chain of custody records for investigational product handling.

Inconsistent protocol amendments that suggest poor change control.

Controls that reduce friction:

Clear delegation of duties with documented evidence that delegated parties are competent and insured.

Robust SAE reporting using a single source of truth. Your insurer should see the same safety data regulators see.

Vendor insurance certificates with appropriate limits, current expiry dates and wording that matches their contractual obligations.

Telemetry and audit trails for all investigational product movements, especially for biologics and devices requiring controlled storage.

Regular internal audits and mock regulatory inspections that identify gaps before regulators or underwriters discover them.

These controls don’t eliminate risk. They make risk visible, measurable and manageable. That’s what underwriters pay for: known risks they can price, not unknown exposures they must guess at.

Decision Framework: When Does Your Trial Need Specific Cover

Understanding when you need additional cover beyond basic clinical trials insurance helps you avoid gaps and control premium.

If you’re running Phase I first in human trials → You need comprehensive investigational product liability and medical monitoring cover. Unknown safety profiles create unpredictable exposure.

If your trial involves novel biologics or gene therapies → Long term effects and delayed adverse events require extended reporting period coverage. Standard policies may limit the period in which claims can be notified after trial completion.

If you’re working with multiple CROs across different regions → Coordination risk and overlapping responsibilities require clear contract drafting and possibly non owned and non operated liability cover to fill gaps.

If your investigational product requires cold chain logistics → Contingent business interruption and spoilage cover become relevant. Temperature excursions that ruin batches can stop trials and create participant safety gaps.

If you’re conducting trials in multiple jurisdictions → Regulatory requirements differ, and insurance requirements vary. What satisfies UK requirements may not satisfy EU or US regulators. Structure your programme to comply with the strictest jurisdiction.

If your trial involves vulnerable populations → Enhanced informed consent procedures and additional safety monitoring may be required. Underwriters will scrutinise your capacity to obtain proper consent and manage safety appropriately.

If you’re using digital endpoints or software as a medical device → Data integrity, cyber risk and software liability become relevant. Standard clinical trials insurance may exclude technology risks.

The real challenge is not buying every possible cover. It’s identifying which exposures you control, which you can transfer, and which you retain by design. Insurance fills the gaps you cannot eliminate through protocol design, vendor selection and operational controls.

Practical Checklist: Prepare This Before You Need Clinical Trials Insurance

Trials documentation:

Protocols, investigator brochures and informed consent forms, organised and indexed.

DSMB charters, safety monitoring plans and SAE reporting procedures.

All protocol amendments with rationale and ethics committee approvals.

Governance and accountability:

Delegation of duties matrix showing sponsor, CRO, site and vendor responsibilities.

CRO oversight records demonstrating active monitoring, not passive reliance.

Vendor qualification records showing due diligence on critical suppliers.

Risk transfer evidence:

Current insurance certificates from CROs, CMOs and logistics providers showing cover types, limits and expiry dates.

Contracts with indemnity clauses and insurance requirements clearly marked.

Evidence that required limits align with exposure (participant numbers, trial value, worst case scenarios).

Incident and safety records:

SAE logs with line by line summaries and outcomes.

Root cause analyses for serious incidents with corrective and preventive actions.

Evidence that corrective actions were implemented and verified effective.

Regulatory and inspection history:

MHRA correspondence, inspection reports and close out letters.

Responses to regulatory queries showing how you addressed findings.

Evidence of continuous improvement based on regulatory feedback.

Operational traceability:

Cold chain telemetry and chain of custody records for investigational product handling.

Batch release records and quality control documentation.

Audit trails for trial data integrity and backup procedures.

Response preparedness:

Incident response plan with named roles, notification timelines and evidence preservation procedures.

Contact information for clinical safety experts, regulatory counsel and insurer claims contacts.

Template notifications for regulators, ethics committees and insurers.

Prepare this documentation once and maintain it as a living system. It’s the single most effective way to reduce underwriting friction at renewal, maintain credibility during fundraising, and respond effectively when incidents occur.

Bottom Line

Clinical trials insurance is not a compliance tick or a single policy. It’s a programme that reflects who controls which risks, how you document decisions, and how you respond when serious adverse events occur.

You remain in control. Insurance gives you access to clinical safety expertise, forensic investigation resources, legal defence and crisis communications specialists. These are people who advise, not people who decide. You make the calls, informed by their experience with hundreds of similar incidents.

The practical steps in this guide reduce underwriting friction, keep contracts negotiable with CROs and sites, protect regulatory relationships, and preserve commercial value during fundraising and M&A. If you’re running trials now or planning trial starts in the next six months, preparing your documentation and understanding what underwriters expect gives you better terms, faster placement and fewer surprises when things go wrong.

Reference Reading

Simplify Stream provides educational content about business insurance for UK companies, especially those with high-growth business models that require specialist insurance market knowledge. We don’t sell policies or provide regulated advice—just clear explanations from people who’ve worked on the underwriting and broking side.