Sunday, March 14, 2010

researching your insurance

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.
Outcompete the FDA.Always comply with regulatory boards and administrations, but
remember that this won't indemnify you from lawsuits. There are many life science insurance
firms that are famous for their FDA compliance, but these firms still
get hit with costly lawsuits. FDA regulations do set some basic
standards for compliance.
All clinical trial companies should look at these regulations as the
minimum, and all should strive to outperform these regulations. In
other words, life sciences companies need to ‘raise the bar' when it
comes to FDA standards.
Avoid Conflicts of Interest
Stay away from any financial conflicts of interest associated with
clinical trials. There are companies that have structured policies
wherein they pay clinical investigators higher salaries if they
investigators can enroll more subjects. Sometimes, this can result in
improper recruitment of subjects.Ensure that there are no financial conflicts between the subject and the investigator.
Recently, the flagship Cleveland Clinic was subject to censure and litigation after discoveries that doctors in the facility had financial ties to medical device firms whose products they were testing at the clinic.
Obviously, blatant forms of bias like this can jeopardize the
integrity of clinical trial data. This will basically invalidate the
evidence gleaned from the clinical trial. Always disclose any compensation agreements between clinical investigators and members of
the IRB. Patients should also sign all disclosures.
Choose Your Employees Wisely
Remember to only recruit experienced investigators who have
extensively worked in clinical research. Don't hire someone who has only conducted research in private practices or medical schools.Only
investigators with formal training in clinical research will suffice.
This training will facilitate communication between the clinical
researchers and the IRB members.This is why it's worth it to invest
the time and analyze the investigators' credentials and experience. 
You'll also pre-empt any arguments by plaintiff attorneys who might claim that you skirted responsibility when hiring clinical researchers.
Ensure Your Researchers are Covered.Only hire clinical researchers who carry third-party liability
insurance.This cannot be overstated.Most product liability policies will exclude coverage for the negligence of a medical professional. 
Third party liability insurance will protect you from excess liability.This way, you can avoid contentious conflicts between sponsors and investigators.
Finally,don't just view informed consent as a perfunctory form.View it as an ongoing process.Informed consent is a delicate procedure that must be followed to strict protocol.The patient needs to be fully aware of all risks and benefits.
Take the time to fully explain all procedures,and answer questions
thoroughly.This will help prevent litigation from even occurring.
While all of these methods will help minimize the risk of litigation,all providers of clinical trials must arm themselves with a strong clinical trial policy. Only powerful insurance will allow life
science researchers to conduct their business securely.
Read more about clinical trials insurance and how to acquire a policy that will keep your life science organization safe.

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