Contract research organizations (CROs) around the world are developing at a rapid pace, but there are growing challenges that must be faced. It is vital to meet increasingly stringent regulatory guidelines in order to guarantee the safety of final products and reduce the number of recalls with a greater amount of detail required regarding the safety profile of drug candidates. It is essential to generate carefully designed studies using expert scientific teams in specific therapeutic areas. This can potentially result in great expense for CROs due to the requirement for extra personnel and an increased investment in technology. PRA is a global CRO that provides services through all stages of clinical development. The company has a GLP-compliant bioanalytical laboratory in Assen, The Netherlands and a second laboratory opened in 2010 in Kansas.

As part of its plans to increase its global footprint to meet client needs, PRA needed to ensure the business worked across geographies as efficiently as possible in a high-quality environment. All procedures and systems needed to be completely harmonized.

The challenge of harmonizing two separate sites while enabling compliance with regulations was countered by utilizing a market specific, laboratory information management system (LIMS). Using a LIMS also helps CROs to increase the pace of the drug development process and connect easily with sponsors by facilitating data integration across the laboratory and throughout the enterprise.

In order to achieve consistency, PRA used its Assen laboratory as the template for the new facility in Kansas. All procedures and systems in Kansas needed to mirror those in Assen. PRA opted to use the Thermo Scientific Watson LIMS system with a single database at both sites to support all laboratory systems and to accelerate report delivery.

The Watson LIMS is capable of managing the total production process, resulting in increased productivity as a result of increased efficiency in sample analysis and the use of laboratory equipment. It has also resulted in lower operating costs, enhanced customer service, and improved compliance with complex regulations.

In order to comply with all regulation requirements and accelerate the lab-to-market timeframe, data reports that are produced by CROs on new drug entries need to be transported to their sponsor companies quickly and without any errors. These reports are subsequently used to submit a new drug application for authorization to the U.S. Food and Drug Administration (FDA). A LIMS enables the required standardization in the transferral of data from PRA to the FDA. This means new drugs can be approved faster, allowing PRA to shorten the drug development process and increase overall productivity.

Use of a LIMS in both locations allowed PRA to work more efficiently and spend less time overseeing administration. PRA anticipates looking further into the accrued benefits of a LIMS in its bioanalytical laboratories by using Watson LIMS to explore a move to a paperless laboratory.