Stay Current With International Clinical Trials Coverage
According to BNet, there were an average of 4.2 million people who were enrolled in clinical trials in the past year and this number is continuing to grow. As the number of trials are increasing so is the complexity of new studies and organizations supporting them. This has increased the need of clinical trial sponsors and research organizations to build customized clinical trial coverage that will protect them. Here we present a handy guide regarding clinical trial and life science insurance.
Manage The Risk of Life Sciences Research
As a company that conducts medical research, you are required to comply with a variety of federally mandated standards. As you do this, part of your plan of action should be to include an airtight insurance policy.
Companies that conduct clinical trials, research new medical devices, or test new drugs are all vulnerable to a variety of different risks. The majority of insurance agencies are not properly equipped to handle the complexity of life science insurance. This is why people involved in clinical trials need to hire an insurance agency that has extensive knowledge of the clinical trial coverage landscape.
If You Do Any of the Following…Then You Need Life Science Insurance
Here's a brief list of the types of companies that need to acquire customized life sciences insurance:
- Companies that research, test, produce, or distribute drugs and pharmaceuticals.
- Companies that assemble, organize, and administer clinical trials.
- Companies that perform contracted research.
- Companies that are seriously involved in the biotechnology sector.
- Companies that manufacture, market, advertise, or test medical devices or inventions.
Rising International Life Science Studies
Many U.S based life sciences companies are administering clinical trials all over the world. This creates a variety of risk management issues that must be addressed. In fact, each country establishes strict rules and regulations for clinical trials and insurance in general. It is the responsibility of any life sciences company doing business in a foreign country to fully educate themselves regarding clinical trial and insurance law.
This also highlights the need for an insurance agency that can build a policy to protect life sciences companies that are working internationally. Most jurisdictions require that clinical trial providers obtain locally admitted insurance. This local insurance must be purchased separately from the company's general insurance policy and may have to be placed by an agency in that country. This leads to the need for a life science company to work with an agency with a global network.
Be Active in Protecting Your Company
It's extremely important for life sciences companies to manage risk proactively. Often, this means finding an agent and carrier who can devise complicated insurance policies for large life sciences companies.
Clinical trial sponsors and research organizations should also ensure that they work with insurance carriers who have expertise in insuring life sciences organizations. In addition they should choose carriers that have international expertise to deal with insurance law and clinical trial administration and have sound financial ratings.
Life sciences companies should evaluate the following factors when deciding on an insurance carrier:
- The carriers ability to uphold multi-national mandated regulations.
- Experience in clinical trial and life science insurance.
- Access to and ownership of a database that contains extensive information regarding legal and insurance mandates.
- Strong financial ratings
- Ability to offer customized products
If you are a clinical trials provider, it's imperative that you select an insurance agency and carrier that will provide you with thorough coverage.
Questions and Answers
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.
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.
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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