Navigating the landscape of clinical trials requires scientific expertise and a robust understanding of the diverse risks involved. Clinical trials insurance emerges as an essential safeguard at the intersection of research, innovation, and risk management. This specialized insurance protects organizations conducting clinical trials from a myriad of potential liabilities, such as patient injury, property damage, and professional negligence. The highly regulated and inherently unpredictable nature of clinical research underscores the necessity of this unique policy.
Clinical trials insurance, sometimes called clinical research liability insurance, is a specialized type designed to cover the unique risks of conducting a clinical trial. This coverage safeguards organizations from potential legal liabilities during a trial.
For example, if a participant in a trial suffers an adverse reaction or an injury, the organization conducting the trial may face significant financial and legal consequences. This policy offers protection against such outcomes, providing a financial safety net in case of claims or lawsuits. Additionally, it plays a crucial role in meeting regulatory compliance and maintaining trust with clinical trial participants.
Why is Insurance for Clinical Trials Important?
Protects Against Legal Liabilities
Clinical trials can involve significant risks, and adverse events may lead to lawsuits. Clinical trials insurance provides crucial coverage to protect the company from potential financial losses and reputational damage.
Ensures Regulatory Compliance
Many regulatory bodies mandate clinical trials insurance as a condition for conducting research. By securing adequate coverage, companies can demonstrate their commitment to ethical and safety standards.
Mitigates Financial Risk
Clinical trials can be costly, and unforeseen events can further strain resources. Insurance can help cover expenses related to legal fees, settlements, and other costs associated with adverse events.
Maintains Investor Confidence
Investors are more likely to support companies that have robust risk management strategies in place. Clinical trials insurance can reassure investors that the company is taking steps to protect its assets and future growth.
General Liability coverage protects companies from third-party claims of bodily injury, property damage, and personal injury, which are essential during clinical trials, where unforeseen incidents can occur. It provides financial security by covering legal fees, medical expenses, and settlements, helping companies focus on trial execution without worrying about unexpected liabilities.
Workers’ Compensation insurance is crucial for protecting employees involved in clinical trials, covering medical expenses and lost wages if they are injured on the job. Given the potential exposure to unique risks in trial environments, this coverage ensures companies meet their obligations to provide safe, secure working conditions while protecting their workforce.
Errors & Omissions insurance, also known as Professional Liability, covers claims of negligence or errors in trial protocols or processes that may harm participants or affect trial outcomes. This coverage is essential in clinical trials, where mistakes or omissions could result in costly legal actions or reputational damage.
Cyber Liability insurance protects companies from the financial consequences of data breaches and cyberattacks, which are especially critical in clinical trials that handle sensitive patient and trial data. This coverage provides resources for breach response, legal fees, and regulatory fines, safeguarding the company’s reputation and ensuring compliance with data privacy laws.
Directors & Officers insurance shields executives and board members from personal liability if they face lawsuits related to their decisions during clinical trials. With high stakes in trial outcomes and regulatory scrutiny, this coverage is vital to protect leadership from financial losses that could arise from trial-related allegations or lawsuits.
Product Liability insurance is necessary for trials involving experimental drugs or medical devices, covering claims if a product causes injury or harm to participants. This coverage mitigates the financial risks associated with adverse outcomes, protecting the company’s assets while providing assurance to stakeholders about the safety of trial products.
Professional Liability insurance protects the medical and scientific professionals involved in clinical trials against claims of malpractice or negligence. Since clinical trials rely on professional expertise, this coverage ensures that any allegations against individual practitioners do not derail the trial or place financial burdens on the company.
The costs of insurance for clinical trials can vary significantly based on factors such as trial size, duration, scope, and the inherent risks of the product being tested. High-risk trials, such as those involving new drugs or medical devices, typically require more comprehensive coverage, resulting in higher premiums.
Key policies like General Liability, Product Liability, and Errors & Omissions (E&O) are crucial for safeguarding against claims of bodily injury, property damage, and professional errors, each adding to the overall cost. Additionally, factors like the number of participants, geographical locations, and regulatory requirements play a role in pricing.
While costs can add up, clinical trials insurance is an essential investment that provides companies with the financial protection needed to navigate potential liabilities, protect trial integrity, and maintain investor confidence. This coverage enables companies to conduct trials with peace of mind, knowing they are prepared for unforeseen challenges without jeopardizing their financial stability.
Clinical Trials Insurance FAQs
Yes, this insurance is typically required to protect organizations from potential liabilities and risks arising during research. Regulatory bodies often mandate this coverage to ensure participant safety and organizational accountability.
Absolutely, insurance for a clinical trial protects research entities from unforeseen events and liabilities, ensuring the safety and rights of participants are upheld and any financial ramifications are addressed.
To secure clinical trials insurance, consult with an insurance broker or agency that specializes in this niche. They’ll guide you through the process, ensuring you have comprehensive coverage tailored to your research needs.
Business liability insurance, often referred to as general liability insurance, provides coverage for businesses against claims of bodily injury, property damage, and other common risks faced during operations.
Insurance in clinical trials offers specialized coverage for organizations conducting medical research, safeguarding against risks like participant injuries, research errors, and regulatory non-compliance. It’s an essential tool for ensuring both participant safety and organizational protection.
Clinical Trials Insurance Insights
ARTICLES
Navigating Evolving Risks in the Biotech Industry
The biotech industry thrives on forward thinking and innovative technology—but faces plenty of risks nonetheless. Here’s an industry-wide look.
Biotech Companies: How Your Pipeline Influences Investors
Biotech companies establish pipelines to land the FDA's approval for novel drugs eventually — but the process helps to secure funding, too. Here's how.
Update: We’ve released a new whitepaper examining the Biotech industry. We dive into the insurance landscape, funding, legal climate, and how to approach risk management...
Finding Clinical Trials insurance coverage doesn’t have to be painful. We aim to make the purchasing experience as streamlined and intuitive as possible.
1
Get a quote
Use our custom-built digital platform to get quotes fast. We automate clerical tasks that plague traditional insurance brokerages, giving us more time to be responsive and alert to your company’s needs.
2
Pair with a specialist
No two organizations are the same. Our team of coverage experts partners with your team to engineer your risk management strategy, together. We take the time to understand the intricacies of your company to get you the best possible coverage.
3
Stay one step ahead
To do better, you need to know better. With changing political, technological, legal, and economic landscapes, staying ahead of the curve is critical.
Our in-house team is tapped into the latest developments in your industry, proactively ensuring you’re covered.
Justin Kozak, Executive VP and Life Sciences Industry Lead
Meet Your Clinical Trials Insurance Specialist
Justin Kozak is the Executive VP at Founder Shield, a tech-enabled commercial insurance brokerage. He leads the Life Sciences practice, having 10+ years of experience in risk management with Hub International, PBC, and now Founder Shield. He launched his career with a BS in History from the University of Delaware, where his keen understanding of the past informs his intuition in the insurance world. It’s no surprise that Justin’s specialty is customizing insurance programs for emerging markets with little historical data. He enjoys spending time with his young family and can’t get enough of the Phillies.
Founder Shield is a leading insurance provider that specializes in offering comprehensive coverage for companies conducting clinical trials, offering numerous benefits and advantages over traditional insurance providers. Here’s a breakdown of some of the key features and benefits that you’ll enjoy with us:
Benefits of Choosing Founder Shield:
Industry Expertise
Founder Shield is focused on protecting rapidly evolving startups. We ensure that our products are tailored to meet the unique needs of Life Sciences businesses.
Customized Solutions
Founder Shield offers bespoke insurance policies that are designed specifically for each client’s needs, ensuring comprehensive coverage that addresses the unique risks associated with digital asset operations.
Fast Quotes
With Founder Shield’s streamlined quoting process, you can receive a personalized quote for your insurance quickly, allowing you to make informed decisions fast.
Ease of Use
Founder Shield’s user-friendly digital platform makes it easy to manage your insurance policies, submit claims, and access important documents whenever you need them.
Dedicated Support
Founder Shield provides exceptional customer service, with dedicated account managers who are always available to assist you with any questions or concerns you may have about your insurance coverage.
Scalable Coverage
As your business grows, Founder Shield’s insurance policies can grow with you, ensuring you always have the right level of coverage for your changing needs.
Founder Shield is a preferred choice for Life Sciences businesses because of our specialization in the industry. We offer flexible and customized insurance policies, a speedy quoting process, and exceptional customer service with dedicated account managers.
Great service – proactive, responsive, go beyond what I have expected from previous providers. The team do a wonderful job
Blockchain
Cannabis
Cryptocurrency
Influencers
Micromobility
On-Demand & Shared Economy
On-Demand Delivery
Robotics
SPACs
Web3
AI
E-Commerce
Education Technology
Esports
Fintech
MSPs
SaaS
Startups
Technology
Life Science Risk Management
Biotech
Dietary Supplement & Nutraceutical
FamTech & BabyTech
HealthTech
Pharmaceutical
Virtual Care, TeleHealth, & Telemedicine
Financial Services
Professional Services
Media & Advertising
info@foundershield.com 
114 E 25th St, New York, NY 10010 
646.854.1058 
Amit Patel
