|
 |
| home > epc > winter 2002 > the great escape - from edc pilot to full scale implementation |
|
|
 PUBLICATIONS |
European Pharmaceutical Contractor
|
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?
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
Industry Events |
 |
4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
|
 |
News and Press Releases |
 |
“PACK DIFFERENT” with EMBALLAGE 2008
“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
More info >> |
|
 |
