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European Pharmaceutical Contractor
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Internet electronic data capture (EDC) is now established as an effective way of conducting clinical trials. Faster access to cleaner data, a more streamlined and less batch-based process and faster database lock are driving real benefits for trial sponsors, leading to a growing acceptance that EDC can be a better way of running studies.
With regions such as South America and Asia Pacific rapidly developing as areas for clinical trials based on the growing importance of these markets to pharma companies, and the adoption of international standards for conducting clinical research, are EDC studies a realistic option for global studies? In fact, online Internet EDC actually facilitates running studies across a number of geographically dispersed countries.
The unique capability to remotely access and centrally manage data as it rapidly accumulates from sites around the world removes the delays and costs inherent in the traditional labour-intensive paper shipping processes. As Internet use spreads rapidly throughout the world, the barriers to deploying EDC are quickly disappearing, making this an increasingly attractive approach for sponsors. There are now many examples of successful EDC trials running beyond the traditional areas of the US and Europe, including sites in Eastern Europe, Africa, Asia Pacific and China.
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By Mark Wren, Director of eService and Support, and Martin Young, Professional Services Director for Phase Forward
Mark Wren brings to Phase Forward over 15 years' experience of successfully implementing technology to the drug development process from both a sponsor and a vendor perspective. Prior to joining Phase Forward, Mark was Director of Clinical Trial Services at Dendrite International where he successfully implemented e-clinical trials systems for many of the large pharmaceutical companies. He has also held managerial positions at the Celltech Group and British Biotech.
Martin Young is Professional Services Director for Phase Forward, responsible for international consulting services and major technology transfer clients. Since establishing Phase Forward's international operations in 1999, Martin has been involved in building the international business and, following the Clinsoft acquisition in 2001, integrating both companies' operations outside North America. Over the past 18 years, Martin has undertaken a number of commercial, IT and re-engineering roles within the IT and pharmaceutical industries. Prior to joining Phase Forward, he worked for Glaxo Wellcome, leading internal and external ventures focused on improving the development process. Martin has a degree in Engineering Science and an Executive MBA.
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Industry Events |
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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 >> |
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News and Press Releases |
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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
More info >> |
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