Our affiliate, Bio-Medical Consultants, specializes in basic science and pre-clinical research. Bio-Medical Consultants has affiliates at many of the top medical centers and universities in the USA, bio-statistical capabilities, and complete histological facilities.

FDA requires demonstration of medical device SAFETY before granting an Investigational Device Exemption (IDE) that will allow you to conduct clinical trials. On some occasions, the necessary safety information can be gleaned from the published literature. Usually, one must conduct animal studies to demonstrate safety in vivo.

Bio-Medical Consultants will provide the following services:

• Selection of the appropriate animal model
• Protocol designed to specifically address FDA-required SAFETY
• Assured Good Laboratory Practices
• Performance Site Selection
• Assist with Animal Committee documentation
• Data Collection forms and other documentation
• Monitor study progress
• Data analysis and interpretation of results
• Presentation of results to FDA
• Evaluation of scientific validity