900 Seconds At XenoTech - Paula Pou

Leading contract research organisation gains hundreds of hours in research time thanks to new QA method

Contract research organisations (CROs) have been growing at an impressive clip since the 1990s when the R&D efforts and needs of pharmaceutical companies started becoming increasingly more complex. Despite their ongoing focus on innovation, most pharmaceutical companies, regardless of size, have also had to bear the weight of increasing external cost pressures, contributing to the downsizing trend over the past five years. CROs have had to step in to not only allow companies to expand their R&D efforts beyond their in-house capabilities, but also to patch up gaps in competencies.

Indeed, CROs provide substantial global capacity to drug developers and have become a critical contributor to clinical trials activity. According to a 2009 study conducted by Business Insights, an independent market research firm, clinical trials conducted by CROs are completed up to 30% more quickly than those conducted in-house by pharmaceutical companies. The study notes that, two years ago, the total CRO market size was estimated at $20 billion and is expected to grow at an annual rate of 8.5% to reach $35 billion through 2015. These kinds of predictions reflect the ongoing growth opportunities for CROs, especially in the current economic climate. However, with more players entering the field, regulatory standards are bound to become more stringent worldwide. Successful CROs will be measured not by the amount of business they conduct, but by the quality assurance of their results.

XenoTech LLC - a Kansas-based CRO founded in 1994 and offering drug inhibition, enzyme induction, and drug metabolism studies for pharmaceutical, chemical, food, academic, and regulatory organisations in the United States, Japan, and Europe - realised the importance of quality assurance in its lab early on. Most of the studies performed by the company are governed by Good Laboratory Practices (GLP) standards to ensure data quality. For XenoTech, a high standard of data quality translated into, among other things, the regular verification of its automated liquid handling equipment. According to Steve Otradovec, XenoTech’s Lab Automation Senior Scientist, the lab’s automated liquid handlers are used primarily for sample preparation and incubation - the bulk of XenoTech’s work.