Clinical Trial Development and Regulatory Approvals
Clinical trials can pose some of the biggest and most expensive challenges an organization will ever face. In fact, costs can run from the tens of thousands to tens of millions of dollars, and may often rival those for the development of the product itself.
Therefore it is critical that when designing a trial, that the right questions are asked and perhaps more important, that there is a clear understanding of the body’s physiologic interactions that affect the response to the device. Interactions that are frequently forgotten about or not fully understood.
Not only must the protocol be designed to answer the question, but the question must be developed to address the corporate need.
- Is it for FDA/Regulatory approval?
- Is it for market acceptance?
- Is it for CMS reimbursement?
All three are different needs but perhaps can be addressed with the right questions written into a solid protocol design.
12th Man Technologies has decades of experience developing clinical trials for both devices and device/drug combination products, many of which have been pivotal trials for FDA approval.