The approval process for new drugs and medical devices is expensive and complicated. It is estimated that it takes an average of 10 years and over $1 billion to successfully bring a new drug to market.
We understand that any delays during the clinical trials process can have a material eﬀect on a company’s ability to deliver a new drug.
Our global network of professionals with life science experience, make sure our clients successfully navigate this challenge and ease the administrative burden they may face in managing the insurance process for clinical trials.
Understanding and complying with insurance requirements to conduct clinical trials across the globe can be burdensome, complicated and time consuming.
Most countries have developed their own rules and regulations regarding insurance and reporting requirements for human clinical trials.
These regulations vary widely, and it is critical to anticipate insurance requirements as part of the submission to any country’s ethics committee.
How we can help
- WTW’s Global Network gives our clients easy access to industry specialists in more than 120 countries.
- We provide access to a database of insurance requirements for more than 150 countries enabling us to provide instant feedback on the requirements for countries you may be considering as clinical trials sites.
- Speed matters. We have a streamlined service model and proprietary market relationships that ensure timely access to country data, policy quotes and certiﬁcates evidencing coverage.
Global WTW stats as at 15 November 2023
What to consider when buying clinical trials insurance
- Compliance with regulatory requirements is vital to successful implementation of international human clinical trials.
- A separate no-fault policy is frequently needed (rather than a general liability extension), often written in local language.
- Many of these countries mandate that insurance coverage be placed with an insurer that is locally licensed to underwrite insurance “in country.”
- The limits of insurance that the sponsor is required to purchase may vary from country to country.
- Many countries obligate the sponsor to evidence proper insurance coverage before an ethics committee can approve a clinical trial.
- Requirements of what certiﬁcates evidencing coverage must show vary from country to country.
- Some territories require an insurance policy period span the full duration of the clinical trial including aftercare rather than the more common 12-month policy period.
Our clinical trials expertise
Our investment in technical expertise benefits our clients every day.
Our teams comprise a cross-section of professional backgrounds and credentials, including professionals with backgrounds as scientists, attorneys, risk managers, brokers, underwriters, risk engineers and claims specialists.
We pride ourselves on:
- Providing an eﬃcient, reliable and time-sensitive service.
- Working in partnership with our insurers to ensure we get our clients broad and compliant coverage.
- Having access to global regulatory and compliance information to ensure we give our clients the right advice. This information is provided by country and includes:
- Non-admitted status
- In-country regulations
- Insurance limits
- Professional liability requirements
- Certiﬁcate protocols
- Speciﬁc information requirements for each country
We understand the challenges faced by the life sciences industry and have the experience and expertise to enable you to make the best decisions and implement the right solutions.
It is a regulatory requirement for us to consider our local licensing requirements prior to establishing any contractual agreement with our clients.