From the category archives: Insurance Protection Blog

Cliinical Trial

Is there an Affordable Clinical Research Liability Insurance Policy?

How do you provide proper insurance:  the right type of clinical research liability insurance for your clinical research organization? Doesn’t the Pharmaceutical or Manufacturer provide indemnification clauses that cover the research organizations?

What if you are a clinical research organization that employs three investigators: (each an M.D. or D.O.) and many independently contracted sub investigators; Some of these (a combination of mid levels  (NP’s, CNM’s and PA’s).

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Is There an Affordable Clinical Research Liability Insurance Policy?

 

How do you provide proper insurance:  the right type of clinical research liability insurance for your clinical research organization? Doesn’t the Pharmaceutical or Manufacturer provide indemnification clauses that cover the research organizations? What if you are a clinical research organization that employs three investigators: (each an M.D. or D.O.) and many independently contracted sub investigators; Some of these (a combination of mid levels  (NP’s, CNM’s and PA’s).

Yes, you  can purchase a policy for  the organization that includes everyone you need to implement your  sophisticated work of the FDA approved trial. 

 

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Clinical Research Liability Insurance


The Doctors Insurance Agency has been providing Clinical Trial Medical Malpractice Insurance for clinical principal investigators and sub investigators for over 15 years.

As investments have flowed into clinical research, the FDA continues to work hard to fast track some drugs to market. The need for clinical research organization liability insurance, site management organization liability insurance, sponsor liability insurance and principal investigator liability insurance has grown concurrently.

Many of our medical malpractice insurance policies already include an endorsement to protect our doctors who work with clinical research sponsors and organizations. Specialists ranging from psychiatry to internal medicine are involved in behavioral health research and are very likely to have coverage via your medical malpractice policy. It is important to work with an agent or underwriter that understands your policy and that can explain this to the organizations doing the research.
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Clinical Trial. Drug Discovery

Clinical trial. Drug discovery. Contract research organization. Sponsors. Preclinical research. Drug approval. Many people have only a vague idea what these words mean. This important work is how  life-changing drugs get to patients — and the important role played by the contract research organization (CRO).

The Doctors Insurance Agency is proud of our developing experience working with Medical Malpractice Insurance companies to endorse the work of our policyholders by including clinical trial  work on our medical malpractice insurance policies.
 
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How to Best Insure Clinical Trial Organizations and Principal and Sub Investigators?

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.
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Clinical Research Organizations Help to Advance Medicine and Improve/Extend the Quality of Lives.

There are many opinions about  the ‘means to the ends’; and, the hallmark of the American Healthcare System is its innovative discover and technology, leading to higher quality of lives for our  society in general as well as those living with chronic disease.

The Doctors’ Insurance Agency is proud  of our work in this niche of clinical research.  There are physicians who supplement their income and use their credentials and education to work as investigators for large Research Organizations.
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Clinical Trials pay for Health Care Providers.

Health Care providers  have to find new ways to find revenue, paying close attention to reimbursement rates and contracts, managing patient safety and patient satisfaction. One of the new areas of finding new revenue is to participate in some way in clinical trials. This is from a large insurance company with whom we work: “Allianz”, sharing ideas and information about the ‘industry’ and risk management, insurance. Clinical Trial Research is a growth industry for physicians and medical practices:  this is, as is the case in many growth industries: because of increased demand.  Some are concerned in our country that we are close to another pandemic/epidemic of illness and disease outbreak. The pharmaceutical industry is well aware of this threat and puts a lot of effort into the development of new drugs to help prevent such threats or cure existing or new diseases.  Drug research follows where the money flows, big pharmaceuticals are protected to make a pro ...
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Insuring unusual Medical Practices

How to insure the unique Physician practice profile When the practice profile is unique, or just doesn’t fit the usual, customary and conventional, Like a medical spa or a family physician who runs an urgent care center, acts as a medical director for a local fire department and sees patients in nursing homes, the insurance niche that handles this is called surplus lines. What is Excess and Surplus Lines and how does it impact Allied Health Providers and Mid Levels Physicians, Midwives and other health care providers are often forced to find insurance at higher rates, or just do not find the right fit. With the continued presence and development of the surplus lines markets, these healthcare providers are newly finding that they can access a Medical Malpractice Insurance market that previously had been available only to very large groups and to practitioners who could not find coverage. The spa procedures, utilization review, administrative duties or other procedures that are considered new a ...
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There can be a lingering risk of a claim in clinical trials?

One of the growing areas in the healthcare field is the area of Clinical Trials.  Clinical trial liability insurance is taken by companies to protect themselves from the risks arising from bodily/physical injury caused to the individual during the process of clinical trials.  The policy protects the research, contract organization from legal liability in some cases.   There can be a lingering risk of a claim in clinical trials: Post-trial risks of up to two months are also covered.    *…there are some exclusions to the coverage:  such as failure of drugs and nuclear chemical risks are usually excluded from coverage. According to the Business Standard: The clinical trial segment could see a period of stable and sustained growth, as the market is expected to become more professional for trials.  As the investment by Pharmaceuticals continues to grow, so will the need for Clinical Trial Liability Insurance.  Specialty and General insurers are deve ...
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Stand Alone Clinical Trial Liability Insurance Policies

Growth in Clinical Trials = New Liability policies Additional  awareness of clinical trial exposures will result in insurance carriers creating new policies, similar to clinic, or urgent care medical malpractice insurance policies or other healthcare facility insurance policies.  There is a trend in the Pharmaceutical  industry to outsource some research to teaching hospitals, which forces the issue of when to purchase a clinical liability insurance policy. Some hospitals are willing to absorb the risk and take it on their policies.  Other hospitals are asking Insurance Carriers  to only cover the professional liability portion of the clinical trial…leaving the financial management/contractual risk uncovered. Some research clients have begun to ask for tailored, specific clinical trial coverage in order to protect themselves prior to signing the contract. Companies engaging in clinical trial work  must be sure to bind a clinical trial liability policy that c ...
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