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| home > epc > winter 2002 > the great escape - from edc pilot to full scale implementation |
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European Pharmaceutical Contractor
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Pharmaceutical companies have been running electronic data capture (EDC) pilot studies for many years now. The first EDC studies really focused on ensuring that the newly introduced technology worked correctly. Initially, the technology was often unsatisfactory, and there were a few iterations whereby the technology was improved to make it more acceptable. These early issues centred on hardware reliability, data communications and finally, software product functionality. While these issues are not fully resolved, the technology is such that it is now possible to run successful EDC studies without too much concern over reliability. This has allowed pharmaceutical companies to start focusing instead on the people and the processes around EDC - areas that must be addressed to facilitate the move from pilot to full-scale production.
This is key as many early EDC studies, though completed successfully, often overran their budget or failed to deliver the benefits expected from using electronic, compared with paper, data collection - such as time, quality or a proactive approach to study management. Some pharmaceutical companies have coined the phrase e-clinical to represent the combined focus on EDC, process and people required to move from EDC pilot to full-scale implementation. Yet progress is still slow. Industry figures show that approximately five per cent of new start-up studies were in 'e' during 2001, with a possible increase to 8-10 per cent during 2002. With such obvious benefits to the trial process why is scale-up proving so difficult?
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Industry Events |
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6th European Forum for Qualified Person for Pharmacovigilance (QPPV)
24-26 April 2012, London, UK
This event is for European qualified persons for pharmacovigilance; deputy qualified persons; senior pharmacovigilance regulators and inspectors; CROs and consultants providing QPPV services; and national responsible persons for pharmacovigilance.
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News and Press Releases |
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Greenphire and Merge Healthcare Form Exclusive Partnership to Integrate Clinical Payment and EDC Platforms
Greenphire announced today that it has
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trial solutions, to offer integrated functionality between Merge’s EDC
technology and Greenphire’s eClinicalGPS site and vendor payment management
technology.
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