Purpose-built LIMS for secure data

Compatible data management systems allow CROs to deliver superior outsourcing for life sciences companies. Using informatics, Thermo Fisher Scientific offers its clients and partners a purpose-built system that reduces costs and improves time to market.

With an investment of nearly 15 years and costs of bringing a new drug to market approaching $2 billion by 2010, pharmaceutical companies are increasingly in search of processes that can help them deliver a return on investment (RoI) during the patent life of the drug.

Big pharma has been steadily moving towards a crossroads and now faces the prospect of no longer having blockbuster drugs as the mainstay product. One way to improve the odds of discovering the next new drug or even the elusive blockbuster is to increase the number of promising drug candidates under investigation. Outsourcing to a contract research organisation (CRO) with specialised expertise can provide the necessary RoI, not only in financial terms, but also in time savings.

Secure data flow
While North America accounts for 60% of the global CRO market, there is also a strong and growing CRO presence in the emerging markets of the Asia- Pacific region, especially in China and India. Any company seeking CRO services will want to ensure that the data obtained and used for determining critical toxicokinetic and pharmacokinetic parameters is compatible to their own, and that data integrity is secure so that final reporting to regulatory authorities is not at risk. While considering the services of CROs, it is important that full compliance with industry regulations such as GLP and FDA 21 CFR Part 11 is maintained.

For companies using CRO services, the need for secure and reliable bidirectional data review is a strategic part of their global growth plans as this determines how effectively the two entities will work together, and how successful the relationship will be.

Sponsors and CROs need a data management solution that delivers purpose-built functionality for bioanalytical laboratories, making workflow as efficient as possible. They also need a solution that facilitates reliable and secure communication of data so that study results are not in question when final reports are submitted to regulatory agencies.

The result of this solution is improved and secure data transmission between the CRO and sponsor company, reduced costs from stored inventory, and improved time to market. This secure exchange of digitised data on a global level improves business decision-making.

PRA International, a leading CRO, has standardised its laboratory information management systems (LIMS) with Thermo Scientific Watson LIMS™ to achieve operational excellence in the management of 150,000 samples each year. Watson LIMS centralises and manages the clinical trail data the laboratory processes, from sample receipt through to sample report.

‘The adoption of Thermo Scientific Watson LIMS is part of the site’s continuous investment into efficiency and innovation,’ explains Peter Ketelaar, vice president of PRA International Bioanalytical Laboratory. ‘Investment in a state-of-the-art LIMS reflects our ongoing adoption of bestin- breed solutions and Watson LIMS fits in that category. 75% of the LIMS in use at our pharmaceutical sponsors’ laboratories are Thermo Scientific Watson. The data transfer between sponsor and PRA International is seamless, since both sides can view the study and data in the same format.’

Partners for success
Improved and secure data transmission between a CRO and its sponsor companies results in reduced costs and accelerated time-to-market. This can only be achieved using an efficient, purposebuilt laboratory information management system such as Watson LIMS.

With a long-standing history of successful implementations and use by 18 of the top 20 pharmaceutical companies, Watson LIMS provides secure data transmission and facilitates compliance that is essential for regulatory approvals. Without this secure automated data capture and transmission process in place, a new drug submission can be delayed or denied by the FDA, wasting millions of dollars of inventory and research.