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European Pharmaceutical Contractor
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To write about EDC in the year 2002 is a somewhat ambiguous enterprise. From a technical viewpoint, a proselyte of this still relatively new technique can be proud of the currently almost exploding number of publications on this topic, which makes him wonder what has been left to write about. On the other hand there are points which can't be stressed often enough, together with the need to take into account all the novelties in this fast-changing environment. From an economic and philosophical point of view, especially after the downturn of the so-called 'new economy' and the recent unpleasant revelations on 'creative accounting' in major companies, the need for positive information regarding the future of this industry is greater than ever. YES, Internet and information technology will revolutionise the clinical research industry, BUT they'll do it at different speeds and in different ways than may have been anticipated some two years ago.
EDC: the market
The market for software and services related to clinical trial processes is worth US$874 million, is growing at 17 per cent a year and will reach US$1.49 billion by 2004 (1). There is apparently a market of remarkable size, reflecting the worldwide interest in this form of clinical data management.
A multitude of different systems and solutions can be distinguished: proprietary systems, developed either by big (multinational) pharmaceutical corporations or contract research organisations (CROs) for their own purposes; 'off-the-shelf' solutions offered by software providers; tailor- made systems of medium-sized CROs, developed in conjunction with web programmers; adapted statistical software systems... a situation characteristic of a pioneering period. Each of these solutions has its distinguishing features.
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Pharmaceutical Stability Testing Conference
15-16 September 2010, CCT Venues – Smithfield, London
The pressure to ensure that the regulatory requirements for stability testing are fulfilled the first time has never been higher with the pharmaceutical industry as a whole, focusing on cutting margins and avoiding recalls. This conference will feature a number of case studies where your fellow peers highlight how they have approached different aspects of Stability Testing to ensure efficiency and compliance.
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Breau Leads Bioanalytical/Analytical Division at MPI Research
MPI Research, the largest single-site preclinical contract research organization worldwide, is pleased to announce that Alan P. Breau, PhD, has joined the company as Vice President of its Bioanalytical and Analytical Services (B/AS) division. B/AS is one of the three core research divisions at MPI Research, along with Drug Safety Evaluation and Discovery Services.
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