The physician always creates the protocol but a statistician, not a physician is best suited to write the design for the clinical trial. The clinical trial is more than just a protocol. Usually when the physician has a disproportionate influence over the design of the clinical trial, the statistical proof becomes an "after thought" of the protocol.
Most clinical trials are designed around this concept- we do not accept this as your model! Science agrees with us.
Compliance Consultants has been consulted on
many Class II, non-significant risk devices. Most of
the clinical data that is required applies either to
improving a claim (in the Indications for Use)
statement or changing the distribution from
prescription to over the counter. Both of these areas
apply more the distribution and merchantability of
a medical device than to safety aspects of the
device.
This burdens the entrepreneur with the task of considering the cost to conduct a clinical trial. Typically, the conventional models from pharmaceutical preparations are imposed on many Class II, non-significant risk devices (the same that require the effects of biodiversity) that require large patient groups. But, Class II devices are not metabolized in the human body and do not need to demonstrate safety in biodiversity. This is the wrong model.
The mentality to require the "bell curves" of Gaullism distribution theory to establish repeatability seldom applies to Class II devices but, medical convention not science requires it. Compliance Consultants realizes this burden and are capable of advising you with in this new realm of thinking. Compliance Consultants considers this to be a political reaction based on incidences that occurred outside the domain of medical devices. It is being imposed on medical devices. We understand these realities and know how to work with you and work with the FDA to come out with a satisfactory approval.
This burdens the entrepreneur with the task of considering the cost to conduct a clinical trial. Typically, the conventional models from pharmaceutical preparations are imposed on many Class II, non-significant risk devices (the same that require the effects of biodiversity) that require large patient groups. But, Class II devices are not metabolized in the human body and do not need to demonstrate safety in biodiversity. This is the wrong model.
The mentality to require the "bell curves" of Gaullism distribution theory to establish repeatability seldom applies to Class II devices but, medical convention not science requires it. Compliance Consultants realizes this burden and are capable of advising you with in this new realm of thinking. Compliance Consultants considers this to be a political reaction based on incidences that occurred outside the domain of medical devices. It is being imposed on medical devices. We understand these realities and know how to work with you and work with the FDA to come out with a satisfactory approval.
