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International Clinical Trials

Unify and Consolidate

 

Pharmaceutical companies face growing competition and tremendous pressure to improve margins while also responding to increasing challenges driven by the evolution toward personalised medicine, with growing demand for treatments targeted at smaller populations with very specific disease states. Consequently, a paradigm shift is underway in the way in which clinical trials are conducted. Pharmaceutical companies are pursuing new ways to reduce clinical development costs, including conducting clinical trials in lower cost areas, such as emerging countries. While the globalisation of clinical trials across a diverse range of patient populations provides research scientists with greater access to subjects and lower recruitment and operational costs, these trials involve much greater complexity, often straining the capabilities of the laboratory informatics systems employed.

Traditionally, diagnostic clinical patient testing is managed using a laboratory information system (LIS). To address the complex demands of clinical trial specimen management and laboratory testing, some organisations find that they need a number of informatics systems alongside a LIS, including laboratory information management systems (LIMS), biorepositories, electronic laboratory notebooks (ELN) and scientific data management systems (SDMS). Of course, relying on a number of discrete systems can cause inefficiencies in the process of data archiving, data searches and information sharing.

A unified laboratory informatics platform seeks to overcome these inefficiencies by integrating LIS and LIMS, including clinical trial management and biorepository management capabilities, along with SDMS and ELN capabilities.


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Joe Tehan is Senior Account Manager, Clinical Operations, for the STARLIMS Corporation. With over nine years’ experience with Mediware Information Systems, and over nine years’ experience in the laboratory group of McKesson Provider Technologies, Joe’s knowledge of and experience in the hospital and clinical reference laboratory marketplace is extensive. Joe holds a BSc in Computer Science from the Washington University School of Engineering in St Louis, US.
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