One of the little known and less discussed aspects of clinical trials is insurance.
What type of insurance, if any, is needed to conduct a clinical trial?
What does purchasing a clinical trial insurance policy entail?
How does starting a new clinical trial impact your medical product insurance policy?
To answer these questions and more, I invited Dan Fuld to the podcast.
Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience.
Dan understands the needs of his clients and leverages his industry knowledge, relationships, and experience to ensure his clients obtain best in class asset protection programs. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space.
Dan graduated from the Katie School of Insurance at Illinois State University where he studied Risk Management and Finance.
Dan received his Chartered Property Casualty Underwriter (CPCU), Associate in Surplus Lines Insurance (ASLI) and Associate in Risk Management (ARM) designation in 2013 and received his property & casualty producers license in 2018.
Please enjoy my conversation with Dan Fuld!
Sponsor(s):
This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
Selected Links for Episode:
Katie School of Insurance and Risk Management
California Casualty Broker Licensing Info
Show Notes:
[3:03] Dan provides background on his education and how he came to the space of clinical trial insurance.
[5:32] An Overview of the scope of clinical trial insurance.
- Product Liability
- Site Insurance
- CROs Insurance
- Medical and professional liability
[10:18] Review of insurance policies organizations may purchase
[16:12] How does one go about determining the type of coverage and amount of much coverage they need?
- US has no actual statutory requirement
- Driven by risk tolerance and liability
- Outside of US countries have stricter rules with regards to trial insurance requirements
- Broker will review informed consent, protocol documents, product details
[20:44] What are the communication expectations as coverage needs change?
- Most US brokers provide blanket trial insurance coverage
- Policy requires seeing finalized informed consent and protocol documents
- Pricing can be really high because trials may not necessarily be a frequent occurrence
[24:03] Sponsor Break: Veeva Vault & Calyx
[27:27] How do informed consent documents tie to clinical trial insurance coverage?
- ICF documents cover a lot of liability due to their broad language and statements about unknown risks
[29:11] Advice for sponsors trying to determine the right insurance partner
- Vet your partners
- Seek out specialized brokers if working outside of the United States
- Consider your brokers ability against the scale of your research operations
[32:22] Review of what clinical trial insurance actually covers
- Highly customized coverage as broker tailors it to the trial and product’s application
- Covers clinical trial, medical monitoring expenses, medical payments, no fault for participants, professional liability for investigators, sites, and contract research organizations
[34:58] Explaining the differences between fault and no fault coverage
[36:21] what do insurance ratings mean for clinical trial insurance companies?
- Insurance companies have professional rating systems
- A- is typically the lowest grade you will want to go with
[37:43] Do investigator initiated studies have different kinds of insurance?
- Yes, but like sponsor trials is dependent on the scope of the investigator initiated study
[39:06] Challenges in finding the right insurance broker
- Limited number of specialized brokers
- Landscape of vendors is international
[41:17] Doing clinical trials outside of the United States
- Most countries want insurance providers to be local
- Trials may need policies in multiple countries if international
[44:29] David’s recommendation for different resources that have helped him professionally
[46:09] Sponsor Break: Calyx
