Obtaining coverage can be a daunting process but it does not have to be this way. That is why it is crucial to work with underwriters who have proven experience in addressing protocols, objectives, ethical certifications and potential language barriers.
Global clinical trials are especially complex due to the regulations, business practices, legal requirements and litigation environments for each country.
How can you tell if an agency uses experienced underwriters? To help your organization acquire optimal coverage, terms and conditions at competitive prices, quality underwriters will strive to develop a comprehensive understanding of your clinical trial(s). To accomplish this, the best underwriters ask a lot of questions to recommend the best balance between coverage, deductions and self-insurance retentions.
Here’s a sample of questions:
- Where will the trials take place?
- What is the trial’s protocol?
- What measures will be put in place for clean room contamination?
- How will bio contamination and spoilage be handled?
- What are the addresses of all investigator sites?
- How will medical and biotechnology research records be backed up?
- What is the cost of recovery if records are lost?
- What is the back up plan if there is a loss in financial contributions, including grants and endowments?
- What was the contract research organization and clinical investigator selection criteria?
- How many patients will be involved?
- What are the patients’ age range, health requirements, _______ etc.?
- How is follow-up being handled?
- Are informed consent forms in the native language of each participant?
- How are participants compensated?
The best underwriters for clinical trial insurance will also:
- keep track of recent developments
- know how to best manage risks with insurance and other measures
- provide benchmarking to compare your organization’s internal risk management practices with peer-group companies
- recommend emerging best practices and
- conduct independent assessment of the trial design
- review informed consent and other documents to ensure completeness, comprehension and readability.
- manage potential conflicts of interest
- include pharmaceutical experts to work closely with clients to establish the exact coverage requirements in each case.
- be singularly focused on tailoring clinical trial coverage for today’s medical technology and life sciences companies to offer a wide array of proprietary product classifications to set rates and prices to meet their unique needs.
- centralized in one location so clients can benefit from consistent underwriting practices, collaborative decision-making and proactive account management.
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