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European Pharmaceutical Contractor

There’s no LIMit

There is clear room for improvement in the administration of clinical trials. Jørn Christensen at LabWare assesses the assets of a new-generation LIMS for international medical research

Laboratory information management systems (LIMS) are now well established as a mission-critical software application for modern laboratories, as organisations strive for improved productivity and enhanced regulatory compliance. Generic, configurable LIMS products have been very successful in pharmaceutical research and manufacturing, but have often been viewed as difficult to adapt to laboratories supporting clinical trial operations. This article describes how additional functionality can be incorporated into a configurable, generic LIMS, and how the software can then be successfully implemented in laboratories analysing samples and managing logistics associated with clinical studies.

NEW-GENERATION LIMS

Commercial LIMS technology has been available for more than 20 years, and many clinical trial laboratories are already equipped with a LIMS of some description. Often these systems are home-built or legacy commercial systems based on old, proprietary technologies. Inflexibility and lack of functionality often leads to frustration with these legacy LIMS and usually provides management with a series of clear objectives for the next-generation LIMS. In particular, it is usually a key requirement that the new LIMS should be configurable, easily adaptable as an organisation’s business evolves and is able to manage a wide variety of studies, sample types and analytical methods.


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Jørn Christensen manages key customer accounts for LabWare Nordic. He graduated as an Electronic Engineer in 1982, and began his career as an Service Electronic Engineer for one of the biggest laboratory equipment companies in Denmark. In 1995, Jørn chose to begin his LIMS career rising to a senior position in a Nordic LIMS company, before deciding to join LabWare in 2005. In this time Jørn has developed good knowledge of many regulated quality systems, the GxP regulations and 21 CFR Part 11, and has been involved in more than 40 different LIMS projects during his career.
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Jørn Christensen
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

MipTec, October 14 – 16, 2008, Switzerland

MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com    
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