chapter  10
24 Pages

Quality Assurance and Regulatory Compliance

Today, there is a continual challenge in clinical drug development to understand

and implement a complete quality system that will ensure data integrity and

regulatory compliance. This is especially true regarding the application of

biomarkers. With the use of novel biomarkers increasing at an exponential rate,

global regulations have been unable to encompass all the technologies utilized. In

fact, most biomarker technologies have little or no specific regulations directing

them. The goal of this chapter is to identify:

The challenges for attaining and maintaining compliance

The components of existing regulations that should guide the development

of a quality system for diagnostic service providers (DSP).