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International Clinical Trials

Regulatory Risk

 

The magnitude and scrutiny of international risk continues to increase for many industries. The highly competitive life sciences industry is also becoming more global as companies search the world for patients to test their technologies and therapies. This changing landscape means that life sciences companies more frequently require counsel on suitable risk management and mitigation strategies. As international clinical trials increase, so too does the demand for clinical trial insurance. Knowledge of the ever-changing regulatory environment for clinical trials insurance, and the speed with which appropriate insurance documentation can be obtained, is vital to the successful launch of a trial.

CLINICAL TRIALS MOVE ACROSS GEOGRAPHIES

A robust R&D pipeline is essential in order to bring new drugs or medical products to market and find solutions to large scale diseases and degenerative conditions. To that end, conducting clinical trials globally – outside one’s own borders – has become an increasingly utilised practice for life sciences firms. The decision to conduct clinical trials overseas may bring about new risks, making the procurement of clinical trial insurance an essential step in the process of certificate issuance and regulatory approval. Life sciences companies may, like other corporations, focus on risks such as business interruption or financial market risk, but clinical trials are the lifeblood of life sciences companies, and it is imperative that risk mitigation associated with clinical trials be taken into special consideration.

Clinical trials insurance supports the drug or product development pipeline by protecting the life sciences company from liability arising from the trial and providing the documentation necessary to support the regulatory filing, so that the authorities will grant approval to conduct the trial. The design of clinical trial insurance can vary considerably from policy to policy, and misjudging the complexity of international requirements can delay clinical trials or increase gaps in coverage. Life sciences companies that utilise specialised knowledge and tools to obtain the right clinical trials liability insurance will reduce their exposure to avoidable risks, saving time, money and valuable resources.


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James E Walters is the leader of Aon’s US Life Sciences and Chemical Industry Sector. He serves as the coordinator on the accounts handled by the group, and is responsible for ensuring the satisfaction of those clients in the design, development and implementation of risk financing programmes and strategies. Prior to joining Aon (then Alexander & Alexander) in 1991, Jim spent five years with a major insurance broker in New York, managing a variety of significant national accounts. He is a graduate of Colorado College, where he earned a Bachelors Degree in Business Administration with a minor in Mathematics.

 

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