Clinical Trials Insurance: CRO & Sponsor Risk Guide

What’s in this Guide

You’re running or sponsoring trials because you want reliable data, regulatory approval and a defensible path to market. Insurance is not a box‑ticking exercise; it’s the mechanism that keeps trials fundable, contracts negotiable and incidents manageable.

This guide tells you, plainly and practically, what insurers expect, who carries which risks, how CTIMP and non‑CTIMP cover differ, and what to prepare at three deal‑critical moments: contracting, fundraising and an incident. It’s written from the underwriting and broking side—what underwriters actually ask for, what claims look like, and the pragmatic steps that preserve options and control for clinical trials insurance.

Who is legally and commercially liable in clinical trials insurance?

Liability is rarely binary. It’s allocated by law, by contract and by operational reality.

Legally, the sponsor holds primary responsibility for trial design, safety oversight and regulatory compliance. That’s the default position regulators and courts start from.

Commercially, liability is negotiated. Sponsors routinely delegate operational tasks to CROs, sites and vendors. Delegation does not equal absolution. Sponsors remain accountable for oversight and for ensuring delegated parties are competent and insured.

CROs and sites accept operational responsibility for delivery, data collection and local safety reporting. They also accept contractual indemnities and insurance obligations. Those obligations should be proportionate to the risk they control.

Practical consequence: allocate risk where it can be controlled and insured. If a vendor controls cold‑chain logistics, make them responsible for temperature excursions and require evidence of appropriate cover. If a CRO runs the trial, ensure their programme aligns with sponsor expectations and insurer requirements.

What clinical trials insurance do sponsors and CROs need?

There is no single policy that solves every exposure. The typical programme is layered.

Clinical trials insurance (CT insurance / CTIMP insurance where applicable) — covers liability to participants for injury or death arising from the trial. For CTIMPs (medicinal products), insurers expect regulatory compliance and robust safety monitoring.
Sponsor legal liability — broader cover for sponsor exposures beyond participant injury, including claims arising from protocol design or failure to obtain proper consent.
CRO insurance — operational liability for delivery failures, data errors, monitoring lapses and local negligence.
Product liability — relevant where an investigational product causes harm outside the trial context or after market authorisation.
Professional indemnity — for professional advice or services that cause financial loss (relevant for CROs providing consultancy).
First‑party covers — property, business interruption and contingent BI for manufacturing or supply failures that stop a trial.
Cyber and data — for breaches of participant data or loss of trial data integrity.
Recall and contamination — for investigational product contamination or batch failures.

Underwriters view the programme holistically. They want to see that the sponsor and CRO have aligned responsibilities, consistent evidence trails and proportionate limits for the scale and phase of the trial.

How does CTIMP insurance differ from non‑CTIMP and device trial cover?

CTIMP insurance sits in a stricter regulatory frame.

CTIMPs are governed by specific clinical trial regulations and require explicit regulatory approvals. Insurers expect documented compliance with those regimes, active safety monitoring, and a clear adverse event reporting process.

Non‑CTIMP trials (e.g., observational studies, some early‑phase device work) can have different risk profiles. Device trials often involve mechanical failure, software faults or human factors. Insurers will probe device design controls, validation, and post‑market history.

Key underwriting differences:

Regulatory evidence: CTIMP underwriting demands proof of approvals, ethics committee sign‑off and safety monitoring plans.
Safety governance: Data Safety Monitoring Boards, stopping rules and SAE reporting timelines are scrutinised.
Product history: For devices, prior field performance and complaint rates matter.
Exposure modelling: Phase II/III trials with many participants attract higher limits and different aggregation concerns than small early‑phase studies.

If you run both types, expect insurers to treat them separately in underwriting and in claims handling.

What do underwriters actually ask for at renewal or placement of clinical trails insurance?

Underwriters are pragmatic: they want to price and manage risk. Their questions reveal what matters.

Typical requests:

Protocols and amendments.
Investigator brochures and informed consent forms.
Safety monitoring plans and DSMB charters.
SAE logs and line‑by‑line summaries of prior incidents.
Delegation of duties matrix (who does what).
Contracts with CROs, sites, manufacturers and logistics providers.
Evidence of vendor insurance (limits, expiry, scope).
Regulatory correspondence and inspection history.
Data integrity controls and backup procedures.

Give them concise, indexed packs. A single PDF with a contents page and clear tabs reduces friction. You remain in control of the narrative; you’re supplying evidence, not surrendering decision‑making.

How should contracts allocate risk and insurance obligations?

Contracts are where risk transfer becomes real. Good drafting preserves insurability and negotiability.

Principles that work:

Allocate risk to the party that controls it. Don’t force a small site to insure systemic design defects.
Be specific about insurance types and minimum evidence. State required covers, limits and that certificates must name the sponsor as an interested party where appropriate.
Avoid open‑ended indemnities. Unlimited indemnities are a red flag for underwriters and buyers.
Use proportional indemnities for negligence. Indemnities tied to proven negligence are more likely to be accepted by insurers than absolute promises.
Address subrogation and recovery. Be explicit about whether insurers can pursue third parties; some policies limit subrogation and that affects recovery strategy.
Include cooperation clauses for claims. Define timelines for notification, evidence preservation and cooperation with insurers.

What underwriters dislike: vague obligations, blanket indemnities, and clauses that require a party to “indemnify for any loss” without fault. Those clauses either increase premiums or lead to carve‑outs.

What happens when an incident occurs: a practical incident playbook for clinical trials insurance

You have access to forensic labs, clinical safety experts, and legal counsel—people who can advise every decision. You stay in control; you make the calls with experienced support.

Immediate steps that preserve cover and options:

Preserve evidence. Stop the chain of custody from being broken. Retain samples, logs, and device firmware snapshots.
Notify insurers promptly. Late notification can prejudice cover. Notify with facts, not speculation.
Notify regulators as required. Regulatory reporting obligations are separate from insurance notification. Follow statutory timelines.
Assemble the response team. Clinical safety lead, legal counsel, CRO operations lead, and a named insurer contact.
Document decisions. Record who decided what and why. Insurers and regulators will want to see the decision trail.
Communicate carefully. Public statements should be factual and coordinated with legal and regulatory advice.

Insurers will want to investigate. They will ask for root‑cause analysis, corrective actions, and evidence of steps to prevent recurrence. That’s normal. It does not mean you lose control; it means you have expert support to make defensible choices.

Scenario: contamination at a phase II site — what actually happens

A phase II biologics trial discovers a cluster of unexpected local reactions at one site. Samples show microbial contamination in the investigational product vials.

What you do, and why it matters:

Immediate containment. The site stops dosing and quarantines remaining vials. That preserves evidence and limits further exposure.
Rapid notification. Sponsor notifies the regulator, the DSMB and insurers within statutory and policy timelines.
Traceability check. You run batch records, cold‑chain telemetry and chain‑of‑custody logs. Telemetry shows a 6‑hour temperature excursion at the distribution hub.
Root‑cause and corrective action. A root‑cause report identifies a failed seal at the fill line. The manufacturer halts the batch and initiates a recall.
Claims and liability. Participants with injuries file claims. The sponsor’s CTIMP policy and the manufacturer’s product liability policy are both engaged. The CRO’s operational liability is examined for monitoring lapses.
Regulatory engagement. The regulator opens an inspection. Your documented corrective actions and rapid reporting reduce the risk of enforcement action.
Commercial consequence. Investors ask for the incident pack during due diligence. You provide a concise, indexed bundle: SAE summaries, telemetry, root‑cause report, corrective actions and insurer correspondence.

Why this approach preserves options: you control the narrative with evidence. You show regulators and insurers that you acted promptly and proportionately. That reduces the chance of punitive enforcement and supports a defensible claims position.

How does clinical trials insurance interact with fundraising and M&A due diligence?

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

What investors expect to see:

Current insurance certificates and policy wordings.
Claims history with outcomes and reserves.
Protocols, safety monitoring plans and DSMB minutes.
Contracts with CROs, manufacturers and logistics providers.
Evidence of vendor insurance and indemnities.
Regulatory correspondence and inspection history.

Practical advice:

Prepare a concise due diligence pack in advance. Index it. Anticipate the questions underwriters will ask.
Be transparent about past incidents. Concealment is far worse than a disclosed, well‑managed event.
If you rely on third parties (CMOs, CROs), ensure their insurance aligns with your deal narrative. Investors will want to see that risk is not silently outsourced.

Underwriters and buyers will probe aggregation risk. A single manufacturing failure that affects multiple trials or sites can create a single event with multiple claims. Be ready to explain how you model and insure aggregation.

What do insurers actually dislike—and what reduces friction?

Underwriters are practical. They dislike uncertainty and poor documentation.

Common friction points:

Vague delegation matrices.
Missing SAE logs or inconsistent reporting.
Contracts with unlimited indemnities.
Lack of vendor insurance evidence.
Poor telemetry or missing chain‑of‑custody records.

Controls that reduce friction:

Clear delegation of duties with evidence of competence.
Robust SAE reporting and a single source of truth for safety data.
Vendor insurance certificates with appropriate limits and wording.
Telemetry and audit trails for investigational product handling.
Regular internal audits and mock inspections.

These controls don’t remove risk. They make risk visible and manageable—and that’s what underwriters pay for.

Practical checklist: what to prepare now for clinical trials insurance

Protocols, investigator brochures and consent forms (indexed).
DSMB charters and safety monitoring plans.
Delegation of duties matrix and CRO oversight records.
Vendor insurance certificates and contract indemnities.
SAE logs and a summary of prior incidents.
Telemetry and chain‑of‑custody records for IMP handling.
Regulatory correspondence and inspection history.
A concise incident response plan with named roles.

Prepare this once and keep it current. It’s the single best way to reduce friction at renewal, during fundraising and in a crisis.

Bottom line in Clinical Trials Insurance

Clinical trials insurance is not a single policy or a compliance tick. It’s a programme that reflects who controls risk, how you document decisions, and how you respond when things go wrong.

You remain in control. Insurance gives you access to expertise—clinical safety, forensics, legal and crisis communications—so you can make informed decisions under pressure. The practical steps above reduce underwriting friction, keep contracts negotiable and protect value at deal‑critical moments.

External Resources

Health Research Authority (HRA) – Insurance and Indemnity Guidance. UK regulatory authority guidance on insurance requirements for clinical trials.
Link 2: MHRA Clinical Trials Regulations. Primary regulatory source for UK clinical trial requirements including insurance obligations.