How to Best Insure Clinical Trial Organizations and Principal and Sub Investigators?

It is important to share to those who may have found their  way to this blog or website;  that we are medical malpractice insurance agents and brokers first and foremost.   We have been representing individual physicians small and large group medical organizations to the doctors company for over 25 years.  

We represent medical doctors , doctors  of osteopathy, podiatrists and some dentists. Policies that we write for malpractice (chiefly with The Doctors Company ,  the nation's largest medical malpractice insurance carrier, will include clinical trial coverage when our physician insureds are asked to participate. This can help the clinical trial organizations that are using them to act as investigators to help investigate and execute the trial. By showing proof of coverage and we will do that we will provide and endorsement to the CRO for the clinical management organization you help them contain the cost of the trial.

Growth area:  Clinical Trials And, this is a growing area. currently lists 199,165 studies with locations in all 50 States and in 190 countries.

As of May 2015, receives an average of more than 179 million page views per month and 61,000 unique visitors daily; Physicians and paramedical have discovered that this is an area of need and can nicely supplement a medical practice suffering from reduced reimbursements.

Clinical Trial Organization Example

One example of a clinical trial policy that we are fighting is a small organization is actually run by a paramedical who then contracts with the sponsor and goes out find research managers as well as medical doctors to monitor and implement protocol. Each clinical trial of course has established and detailed protocol and procedures outlining who is provide the service what healthcare provider,  how many participants , age and gender,  whether this participant is suffering from a disease that is be targeted or not, the practice setting,  County , state there are many details outlined in the contracts and protocol.

Underwriting and Rate determination

This is information not included here for the details of the different phases of approval required by the federal drug administration however it is to outline what is necessary in order to apply for and obtain one of these policies. Just as a medical malpractice policy is underwritten and price by looking at the variables of the specialty County hours procedures and services provided as well as the revenue projections ,  clinical trials are rated and coverage outlined by these variables outlined above

An Insurance task that is easy is when a another clinical trial organization contracts one of our medical malpractice lives and  asks if they will participate as an Investigator or  sub investigator; they simply have to inform their medical malpractice underwriter of  the dates, described the types of services they will be providing , include information about clinical trial sponsor the clinical research organization that is contracted them perhaps provide a copy of the contract;  and then keep the underwriter apprised of significant and material changes in service .  

Adding Clinical Trial Malpractice can change the underlying physician’s rating: It should be noted for example they are presently rated as part time by their medical malpractice carrier then the added work outlined by a clinical trial contract may bump them to full-time and resulted in increase in premium however, the work would still be covered by the endorsed policy.

Growth and revenue  supplement although physicians certainly call into participation trials across all specialties we are seen an extraordinary number of opportunities for ophthalmologists anesthesiologists internal medicine and dermatology. There are clinical research management companies with which you can contract to run a clinical trial for you or to simply contract for your services in a time such as this so much change and uncertainty this seems to be an area providing some financial relief

Two Separate Insurance policies for clinical research organizations
It seems that once a medical doctor or podiatrist learns how to manage clinical trial they can confidently go out and bid for this type of work. Structuring two separate malpractice policies is really the best solution when you become fully engaged in running  the clinical trial organization business
we like two structure the medical malpractice clinic  policy to be completely separate from rom the clinical trial organization liability policy.   Clinical Research Org  policies can be written to include all medical doctors and paramedical investigators and sub investigators they can also include clinical research managers medical assistance and technologists needed to run monitor implement the trial.

Minimum premium for clinical trial professional and general liability insurance.

Would anticipate that most startup clinical trials will pay approximately 5000 and annual premium for 1 million 3 million. Depending on the services there might be a separate sub limit cutting the insurance down to 100,000 the only in instances that are extreme and involve great risk most of the clinical trials are very careful with limited number of participants in order to control and really study and benefit from the outcome.


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