Breakthroughs In Clinical Trials Coverage
ACE Progress Reports has recently published a breakthrough study regarding clinical trial coverage. The study, titled "Managing the Foreign Challenges of a Global Insurance Program: Foreign Clinical Trials Case Study", has received widespread attention in the insurance community and beyond. The study highlights the growth of international clinical trials, and their effect on risk management and insurance policies.
The Prevalence of International Clinical Trials
Increasingly, American life sciences companies are conducting business on an international level. Access to a variety of patient demographics, lower clinical trial costs, and better accessibility to fulfilling study factors are all criteria that have contributed to this trend.
Overseas clinical trials are starting to make up more of the bulk of trials that companies are involved in. This has presented clinical trials companies with new challenges pertaining to their insurance. For example, most countries require that a life science company purchase locally admitted insurance before beginning any clinical trial. This local insurance policy must comply with any insurance laws set forth by the host country.
A Bevy of Regulations
Life science institutes are also required to turn in their certificate of insurance which is written in the local language. Many countries require the approval of a clinical trial by an ethics committee before the trial can move forward.
No life sciences company should enter into such territory without full knowledge of the laws and regulations of the country they are operating in. Many insurance companies simply don't know the specifics of international risk management, which leaves life sciences companies unprotected both in their clinical trials and business operations.
Some countries, such as Brazil, require that a local insurance broker be hired to process insurance premiums and other fees. Still other countries require that the clinical trial sponsor hold a physical presence in the country and carry specific insurance limits for their clinical trial coverage.
Choose A Seasoned Insurer
The study also recommends the importance of hiring an insurer that understands new and emerging threats to life science companies. All clinical trial providers need to proactively protect themselves from litigation. This is done by purchasing a policy from an insurance agency and carrier that can handle multinational business.
Only insurance carriers that possess specific life science underwriting experience should be considered. Life sciences companies should look to choose an insurance agent that has expertise and carrier access to cover any international life science exposures.
Customize Your Policy to Meet International Needs
The insurer must be able to provide comprehensive coverage for their client, which may mean tailoring a policy that will cover the client in a variety of jurisdictions and aligning with a master policy.
Life science companies that wish to do business globally need to analyze a variety of factors when choosing an insurance carrier, including: the ability of the insurance company to compete in a global market, the company's access to jurisdictional resources, the company's possession of a regulatory database, experience with international clinical trials, and a proven history of providing strong coverage to life science institutes.
In this way, life science organizations can take proactive steps to protect themselves, and can also expand their horizons to do business in other countries.
Questions and Answers
Nowadays, it is becoming increasingly common for insurance companies to offer clinical trial coverage for patients. But very few clinical trial providers and investigators understand the importance of building customized clinical trial coverage that will protect them. Here we present a handy guide regarding clinical trial insurance.
The majority of legal jurisdictions require medical research companies to hold clinical trial insurance. Clinical trial insurance is just a part of the risky game of clinical trials. You should find an insurance provider with experience in clinical trials insurance before you buy. That being said, there are ways to minimize your liability risk when it comes to clinical trials. Here are a few ways you can reduce that risk.
While clinical trial insurance is a necessity for any company that conducts clinical trials, many companies do not adequately fulfill their responsibilities when it comes to informed consent. Informed consent requires a deliberate process. This is not just a form that research coordinators push onto subjects.
Sponsors of clinical trials are greatly exposed to litigation, and so must acquire clinical trials insurance that will protect them. Many enterprising attorneys will capitalize on vague language in informed consent documents to provide their case. Here are a few tips to build ironclad informed consent documents.
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Nowadays, it is becoming increasingly common for insurance companies to offer clinical trial coverage for patients. But very few clinical trial providers and investigators understand the importance of building customized clinical trial coverage that will protect them. Here we present a handy guide regarding clinical trial insurance.
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