Clinical Trial Quality

Today we have a special guest blog from Steve Ehrhard, our Quality Assurance Director.
We all know about quality control. We experience the results of it in most everything we encounter. Did I get a good haircut? Are the apples fresh? Did the car get fixed correctly? Will the software actually do what I think it will do? Is the car going to get good gas mileage? There is a lot of activity going on behind the scenes to answer these questions.

When we think of quality, we think of it most often in two ways. First, is the service delivered to us error free or do the goods that we buy come to us without defects or problems? Second, does the product (goods or services) have the necessary design features to meet our needs? These two ideas, quality in the sense of design and quality in the sense of deficiencies, generalized by Dr. Joseph Juran and others, provides a means to both understand how to think about quality, and how to achieve it. That is, a business of providing goods or services must design the offering to meet needs and deliver it defect free.

Clinical trials have quality considerations. The drug or medical device that is being tested must be provided without defects or, in regulatory terms, adulterated or misbranded. It would be ethically wrong to subject a person to a drug or device that we knew was adulterated or misbranded. In a clinical trial, the drug or device has been designed to achieve a particular diagnostic, therapeutic or disease treating objective. That's, of course, what the trial is designed to confirm. International regulatory bodies have created rules to make sure drug and device manufacturers ensure a quality of design and flaws in the study are prevented.

Clinical trials also have "people" considerations. Are patients subjected to the safest protocols we can design? Is privacy protected (HIPPA)? Did the patient consent to participate? Regulations also require a number of actions and rules that a drug or device clinical trial sponsor must follow to ensure there are no exposures in the design of the trial and no problems with how it is conducted.

Certus International, as a Contract Research Organization, is in the business of managing clinical trials. Our product is information, and we have an extensive set of procedures and activities to ensure that our clinical trials are properly designed and executed. Clinical study protocols and plans undergo extensive analysis ensuring that objectives are clear, achievable and logical for drug or device testing. The design of data collection and analysis is carefully considered to make sure that the diagnostic or therapeutic effect of the drug or device can be discerned. Procedures at the clinical sites are designed to address how study subjects are treated and protected. During the trial, we review data extensively, as it is collected (called source data) verifying that it is accurate and precise (defect free) so that it is analyzed correctly.

Our quality objective provides a clinical trial sponsor with information about the drug or device that is trustworthy and reliable and can be the basis for ultimately approving for use in diagnosing or treating disease. The data we collect, and make sure is sound, through quality assurance, is eventually used to establish a drug or device's safety. In other words, quality assurance means helping people by making sure their drugs and devices are as safe as possible.