samedan logo

 
 
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.

 You must be a member of the site to make a comment.
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

IATA CEIV Pharma certificate of Turkish Cargo renewed

Turkish Cargo, the air cargo brand flying to the most countries around the world, extended the validity period of its IATA CEIV (Center of Excellence for Independent Validators) Pharma certificate to 2022, proving its success in all processes throughout the air transportation of medicinal products.
More info >>

White Papers

The BioPharmaSpec Approach”: Mass Spectrometry Based Host Cell Protein Identification and Quantitation

BioPharmaSpec

1. Introduction As part of the development of any biopharmaceutical product, the impurities present must be examined, minimized and where possible characterized (1). These impurities fall into two broad categories: product-related impurities (derived specifically from the drug product itself) and process-related impurities (derived from material associated with the production, processing or purification of the sample). Host cell proteins (HCPs) are process-related impurities that require specific analysis due to the multitude of naturally occurring proteins expressed in the production cell line.
More info >>

 
Industry Events

2020 Avoca Quality and Innovation Summit

3-4 June 2020, Amsterdam, The Netherlands

The 2020 Avoca Quality and Innovation Summit will take place 3-4 June 2020, in Amsterdam, The Netherlands.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement