spacer
home > epc > spring 2004 > edc - the key to success
PUBLICATIONS
European Pharmaceutical Contractor

EDC - The Key to Success

Electronic 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 EDC 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

Industry titans Biocon, PBOA, PCI Clinical Services and Pharmatech Associates join CPhI annual report for 2015

CPhI Worldwide, organised by UBM EMEA, announces the addition of four new high profile experts to the CPhI annual report, taking the total up to a record breaking 14 panellists for 2015.
More info >>

White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
More info >>

 
Industry Events

The Pharmaceutical and Medical Device Labelling Summit

27-28 October 2015, Maritim proArte Hotel Berlin

Optimise Your Labelling Strategies to Ensure Accurate Product Information and Successful Regulatory Compliance. 1 Event, 2 Streams. Join us in Berlin this October to benefit from industry leaders providing their experience and expertise within this complex and ever-changing landscape.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement