Using LIMS for Operational Excellence in Contract Research Organizations

A recent research study published by Business Insights Ltd. titled “The CRO Market Outlook: Emerging Markets, Leading Players and Future Trends” projects an annual growth rate of 14-16% for the CRO market to reach a value of $24bn by 2010. CROs have been established as full service providers offering focused and expertise-rich solutions for a range of activities, from research and development (R&D) to clinical trials and manufacturing through to marketing. This substantial growth is driven by the capability of CROs to achieve optimum cost efficiency, manage peak workload, compensate limited global reach and reduce time-to-market. In addition, outsourcing takes the burden of non-core activities and transactional tasks off companies and allows them to focus on their core competencies. However, despite strong growth, the global CRO market faces a number of challenges.

Challenges Facing Contract Research Organizations

The most important challenges facing the CRO industry are strict regulatory requirements and pharmaceutical consolidation. Worldwide regulatory bodies increasingly require more detailed safety control of drug candidates to ensure safety of final products and avoid potential product recalls. In order to comply with these regulations, CROs must generate more carefully designed studies, which can only be achieved using scientific teams of great expertise in specific therapeutic areas.

One of the ways to address these challenges and succeed in the competitive CRO market is to implement market-specific, high-performance Laboratory Information Management Systems (LIMS) with expandable capacity and quicker delivery speed. CROs must continuously upgrade their technological capabilities and utilize the latest LIMS solutions to help them integrate data to speed the drug development process and to connect seamlessly with sponsors.

Contract Research Organizations Requirements

CROs have special considerations when it comes to LIMS implementations. They need to deploy LIMS that contain built-in capabilities and targeted analytical tools to help them serve the varying needs of their pharmaceutical sponsors. The LIMS of choice must be capable of gathering, analyzing and storing large volumes of data for both standard and complex studies. Data must be reviewed, summarized and presented in compatible report formats to facilitate seamless communication and data transfer between CROs and their customers as well as rapid review and approval. Secure transmission of information is also of paramount importance.

Investing in a LIMS to manage the entire production process from sample receipt through to analytical report provides a number of benefits including improvements in sample throughput, more efficient use of laboratory equipment and limited downtime for instruments. The primary process of sample analysis is run more efficiently while also achieving faster and more reliable quality control. In addition, powerful LIMS solutions are specifically designed to comply withGLP and 21 CFR Part 11 regulations.

LIMS solutions will automatically integrate data from many different laboratory instruments, enabling collaborative research. The LIMS will facilitate better decisions sooner, increase productivity, lower operating costs and improve quality and customer service, all while achieving compliance with strict regulatory requirements. The delivery of data reports from the CRO to its sponsor company need to be completed as quickly and seamlessly as possible to maintain compliance requirements and to help accelerate time-to-market. Datareports produced by the CRO on new drug entities are subsequently used by the sponsor company to submit a new drug application for approval to the ultimate decision maker, the US Food and Drug Administration (FDA).

Application Example

As part of its ambitious plan to implement tech­nological innovations that promote operational excellence and regulatory compliance, PRA International has standardized on a LIMS from Thermo Fisher Scientific in its bioanalytical laboratory. PRA International is a global leader in contract clinical development services and operates a state-of-the-art, GLP-compliant bioanalytical laboratory, which provides pharmacokinetic/pharmacodynamic analyses, including endogenous compounds and biomarkers. They required a powerful LIMS to integrate with and manage data generated from different LC-MS, UPLC and HPLC systems.

PRA International chose Thermo Scientific Watson LIMS to take advantage of the system’s flexible reporting tools as well as its universality since the system is the industry-standard LIMS, used by 18 out of the 20 largest global pharmaceutical companies and 19 out of the 20 leading biotechnology and contract research organizations worldwide. Since its implementation, the LIMS has allowed totally seamless communication and data transfer between the company and its pharmaceutical sponsors, fast sample turnaround, reduced costs and improved operational efficiency.

Watson LIMS has been capable ofmeeting the bioanalytical laboratory’s need for GLP and 21 CFR Part 11 compliance. Built-in security and audit trail capabilities provide maximum flexibility and configurability while preserving data integrity. The system uses a central Oracle database and offers a simple, point-and-click graphical interface that has been quick to learn and easy to use. Study results are organized in a unique document management system and shipments and samples are tracked through user-designed barcode labels.

The LIMS supports a wide range of PK/TK analyses. In the case of ClinicalFirst-in-Humans studies, for example, Watson LIMS meets the challenging requirement of analyzing and reporting on approximately 200 samples within 48 hours. At the PRA International bioanalytical laboratory, LC-MS information is imported into Watson LIMS, where the concentration data are calculated using standards for each run and evaluated with QC samples. Reports follow a consistent format across all types of techniques, enabling true data consolidation across different studies and projects.

Peter Ketelaar, Vice President of PRA International Bioanalytical Laboratory, explains: “75% of LIMS in use in our pharmaceutical sponsors’ own working laboratories are Thermo Scientific Watson. The data transfer between sponsor and PRA International is seamless within Watson LIMS, since both sides can view the study and data in the same format. As a result, now that we have standardized on Watson LIMS our sponsors view the LIMS as an additional reason to work with PRA International.”

Conclusion

Implementing a market-specific LIMS solution has proven to provide many immediate benefits to CROs. LIMS help CROs to address the challenges of stringent regulatory scrutiny and pharmaceutical consolidation while improving laboratory productivity and minimizing costs through flawless transmission of data between themselves and their many pharmaceutical sponsors. LIMS enable the CRO market to meet its aggressive business and technology requirements by equipping laboratories with a scalable, easy-to-configure automation solution, providing CRO laboratories a competitive advantage and superior customer service.

For more information about Thermo Scientific informatics solutions, please call on +1 866-463-6522, e-mail marketing.informatics@thermofisher.com or visit www.thermo.com/informatics

About the Authors:

Peter Ketelaar is Vice President, Bioanalytical Laboratory PRA International in Assen (NL). Peter joined PRA in 2005, having formerly been in senior management roles at DSM and Codexis with responsibilities in Europe and Asia Pacific. Peter has extensive pharmaceutical industry experience and is currently responsible for extension of PRA’s laboratory activities internationally as well as co-management of the PRA Business Unit Early Development Services. 

Trish Meek is Director of Product Strategy, Life Sciences at Thermo Fisher Scientific. Trish Meek joined Informatics when Thermo Fisher acquired Thru-Put Systems, Inc. in June 1999. She is the Director of Products Strategy, Life Sciences, and is responsible for determining the strategy of Thermo Fisher’s current portfolio while identifying new market opportunities within the Life Sciences.  Trish Meek has worked for Thermo Fisher for the past nine years in the development, sale, support, and marketing of laboratory software.  A graduate of Loyola University with a BS in Chemistry, Trish began her career doing environmental analysis and chemical vapor deposition research.

About PRA International

PRA International is a leading global clinical development organization that provides comprehensive Phase I-IV clinical development services and operates in more than 30 countries across six continents, with over 3,600 employees. PRA is committed to reliable service delivery, program-level therapeutic expertise, global access to knowledge, with an involved senior management.

About Thermo Fisher Scientific Informatics

Thermo Fisher Scientific is the worldwide leader in laboratory software and related services, providing enterprise-wide multi-laboratory solutions that have become the corporate standard at leading organizations. The company’s Thermo Scientific LIMS and CDS are facilitating laboratory data in the world’s leading pharmaceutical companies, petrochemical and chemical plants, food and beverage manufacturers, and other major industries. To support its global installations, the company provides implementation, validations, training, maintenance and support from the industry’s largest worldwide informatics services network.