Clinical trials are crucial for curing illnesses and saving lives. These studies validate the effectiveness of medical interventions, discover ways to prevent diseases and conditions and identify risk factors and symptoms for potential diseases.
Conducting medical research or developing 510(k) products is worthwhile. It is also risky. Safeguards to legally protect trial administrators, such as federal laws and informed consent forms, do not fully cover the risk of financial and reputational liability.
Consider just some potential reasons for legal claims: contract performance failure, insufficient monitoring, misreporting information or inadequately providing information to participants and partners.
Since each country has its own rules and regulations for clinical trials, manufacturing or service, there can be great exposure for international liability. There are also costly taxes if a program is not structured properly. Clinical trial coverage can provide an extra measure of security for that as well.
Because organizations involved with clinical studies could face hundreds of thousands of dollars in legal costs, clinical trial insurance is necessary. Even organizations just tangentially connected are likely to need clinical trial coverage.
Organizations that should consider coverage are:
- research companies and organizations, including colleges and universities
- clinical trial service companies, such as facilitators and hospitals
- medical researchers and developers in pharmaceutical, biotechnological, nano technological, genetic and other related fields.
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