Friday, May 25, 2012

Fault-Finding to Success

Consumers are always seeking a quality product – no matter what industry the product is intended for. However, the complexities of most products today bring about an inherent problem: one industry does not necessarily control production up and down the chain. Thus, it is generally difficult to ensure quality control beyond one’s own company. This lack of control could be unnerving, if not for an unexpected, guiding principle: fault.

This principle of accountability holds true within the realm of Clinical Research Organizations (CROs). Liability drives companies to create better products, and fault is an ever-present motivator. In the case of CROs, these organizations find themselves in a delicate position of having to be cautious about whom they are dealing with in both upward and downward directions: medical sites, clinical research assistants, sponsors and subcontractors.

Every step of the way, your contracts must stipulate that the quality of work is guaranteed, and allocating fault and responsibility is a key element to that.  No matter who is involved in the process, though, there must be assurance that quality is assured, starting at the top and running straight to the bottom. 

My yard, like many yards, is inhabited by a number of squirrels who assume they belong on my property. My dog will bark, informing them that this is, in fact, not their yard. While an audible yap is not necessarily a powerful deterrent to the squirrels and their trespasses, the constant threat and physical presence of the dog keeps them on their toes. People in contracting relationships can think of the dog’s bark as “fault.” While the persistent threat looms, there is always the possibility of greater danger – such as a loose dog that can chase you.

The liability associated with a bad drug reaction – or even worse, introducing a dangerous or deadly drug to market – is huge. To prevent this from happening, CROs must have clearly defined guidelines and expectations for all the organizations and individuals involved. This runs deeper than being a blueprint for the “blame game.” This means establishing a method to ensure data integrity, which, in the realm of CROs, ultimately translates to public safety and health. CROs are not just trying to indemnify themselves, but they are making sure that every step along the way preserves the highest quality work.

The world of life science is a challenging and competitive ecosystem of tests and trials. Fortunately, there are some governing principles that help ensure the safety of those within it. For CROs, they can feel assured that the threat of fault will ensure that the best product possible can come from the system, and the greatest good can be done so that the consumer can have the maximum benefit.