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International Clinical Trials

Strength in Unity

 

THE GROWING CHALLENGE

It is no secret that the effort and costs involved with conducting a clinical study have dramatically increased. The Tufts Center for the Study of Drug Development reported earlier this year that trials have become more complex, with a 6.5 per cent growth rate in the number of unique procedures per protocol between 1999 and 2005, and are taking more time with the number of days from protocol design to database lock, rising by nearly 70 per cent between 1999-2002 and 2003-2006. With healthcare evolving toward personalised medicine, and a growing push toward adaptive clinical trial design, the need for flexibility in managing greater numbers of clinical studies will be critical. With laboratory data playing a key role in most clinical trials, the laboratory informatics systems employed must be flexible and agile, as well as capable of coping with the challenges and complexities of current and future clinical studies.

SHORTCOMINGS OF THE TRADITIONAL APPROACH

In order to manage laboratory operations in regulatory compliant fashion, multiple software systems are often deployed. These can include clinical trial management systems (CTMS), laboratory information management systems (LIMS and/or LIS), and  biobanking software, electronic laboratory notebooks (ELN) and method or laboratory execution systems (MES/LES). Furthermore, a variety of legacy software systems may be present within a multi-site enterprise due to corporate evolution and mergers/acquisitions. ‘Flexible’ and ‘agile’ are not typically adjectives that an IT manager would use to describe such a patchwork of multiple laboratory informatics systems used to support clinical trial laboratory operations.


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Ed Krasovec is the Director of Clinical Operations for STARLIMS Corporation. He oversees business development, product management and project implementation for clinical laboratory applications, including healthcare, biospecimen management and clinical trials. During the past 10 years, Ed has founded and sold a clinical informatics company and has championed efforts to expand LIMS presence in clinical laboratory applications. He has 15 years of management and technical experience with DuPont in laboratory management, business planning, research and operations. Ed holds a BSc in Chemical Engineering from Penn State University and an MBA from Drexel University.

 

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