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European Pharmaceutical Contractor

The Great Escape - From EDC Pilot to Full Scale Implementation

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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By Dr Graham Bunn, Global Vice-President of e-Clinical Business at Quintiles

Dr Graham Bunn has studied and worked in computers and life sciences throughout his lifetime. His health care experience started in 1988 when he joined BBN Software Products as a Pre-Sales Technical Consultant selling statistical and data management software to the pharmaceutical industry. Graham joined Quintiles in 1990 and worked in both global IT and EDC business solutions roles, seeing the company grow from 350 people to 20,000 in 1999.

After this, Graham spent two years at Domain Pharma (also known as Clinsoft) where he was the Global Vice President for business IT, responsible for providing Internet data capture solutions to the pharmaceutical industry. He has recently re-joined Quintiles as their Global Vice President of e-Clinical Business where he is responsible for implementing e-clinical data capture and eCRM solutions worldwide. Graham has chaired and presented at many industry seminars on EDC, e-clinical and IT, and written many articles published in leading journals and industry publications on making the change to electronic data capture.


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Industry Events

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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