spacer
home > ebr > winter 2003 > edc - the key to success
PUBLICATIONS
European Biopharmaceutical Review

EDC - The Key to Success

lectronic data capture (EDC) for clinical trials has been around in one form or another for a number of years with the technology continuously evolving over this time. Although low volume or pilot usage of EDC does not yield the full benefit of this technology, increasing confidence in the technology together with the operational benefits highlighted by some companies (1) is leading most companies to set EDC adoption targets with 60 to 90 per cent of new study starts by 2006 not being atypical (2).

Because full ROI on EDC usage is not realised until EDC is the default means of running a clinical trial, breaking out of low volume or pilot usage of EDC frequently requires a leap of faith. As more companies take the strategic decision to scale their use of EDC, the EDC life cycle will move from its current position where it is really only the early adopters that are taking full advantage of the benefits of the technology. In addition to the leap of faith, a strategy and plan are required in order to effectively overcome the inertia caused by the existing organisation and application set. Processes, organisation and technology should be included in the strategy for scale up. EDC software selection directly affects (or is affected by) the technology strategy. The software selected, in turn, will have an impact on processes, organisation, logistic and training strategies.


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
By Colin Spink, Industry Specialist at IBM Business Consulting Services and Brent Cliveden, Vice President of Operations North America at InferMed Ltd.

Colin Spink, BSc, MPhil, MIEE, CEng has worked with IBM for 15 years, focusing on the pharmaceutical industry for the past 12. He has been specialising in clinical development for six years, working on numerous client engagements over this time. Colin's particular area of interest is electronic data capture in clinical trials and he is also the author of White Paper Realising the Full Rewards of Electronic Data Capture.


Brent Cliveden is Vice President of Operations (North America), at InferMed Ltd, and is responsible for extending InferMed's sales activities from Europe into the US and Canada and for supporting consultancy and project management services in that region. During the 10 years before joining InferMed, he worked for several other EDC vendors, as well as being a Principal at IBM Healthcare Consulting & Services, and Practice Leader for IBM's Clinical Trials Solutions Group.

spacer
Colin Spink
spacer
spacer
spacer
Brent Cliveden
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Nova Biomedical Launches BioProfile® FLEX2 On-Line Autosampler for Fully Automated Sampling, Analysis, and Feedback Control of up to 10 Bioreactors

Waltham, MA – Nova Biomedical is pleased to announce the launch of the BioProfile FLEX2 On-Line Autosampler (OLS), a modular system that connects as many as 10 bioreactors to one FLEX2 analyzer for up to 3 weeks of walkaway, automated sampling, analysis, and feedback control of key cell culture analytes. The FLEX2 measures up to 16 tests including pH, gases, metabolites, osmolality, cell density, and cell viability.
More info >>

White Papers

How To Increase Efficiency, Customer Satisfaction and Reduce Cost

AC Labels

A customer of Riverside Medical had required a complex four-part 'piggy back' label. The labels needed to be specially constructed to facilitate removal in parts at various stages of its use for quality control traceability. This label needed to carry variable data elements of LOT numbers, batch numbers and product descriptions, and also a secondary gamma indicator label placed on each of its 4 sections to prove its sterility following sterilisation.
More info >>

 
Industry Events

Clinical Trial Supply Europe

11-12 March 2020, Madrid, Spain

The 21st annual edition promises to grow on the success of 2019s excellent conference which saw delegates from Europes largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement