spacer
home > ict > winter 2009 > strength in unity
PUBLICATIONS
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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.

 

spacer
Ed Krasovec
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Nemera and Noble announce collaboration to support patients who self-administer medication

Nemera is excited to leverage the new collaboration to expand end-to- end offering of the parenteral franchise and increase patient onboarding through safer multi-use training devices
More info >>

White Papers

galenIQ - The smart excipient

BENEO GmbH

galenIQ combines a multitude of outstanding characteristics and is suitable for a wide range of pharmaceutical applications. galenIQ can be used as more than just a bulk excipient. It also serves as an anti-caking agent, anti-humectant agent, stabilizer or oral care and taste agent to mention just a few additional functions.
More info >>

 
Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement