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| home > epc > spring 2002 > what you should expect from a user-friendly edc solution |
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European Pharmaceutical Contractor
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'User-friendly' is one of the most commonly misunderstood phrases in the computer lexicon. For years, every software package claimed to be 'user-friendly', diluting what the term actually means. Many purchasing agents began to ignore the claim because it was so difficult to quantify. Consequently, the term all but disappeared.
However, in the world of clinical trial software, it is dangerous to ignore the term 'user-friendly' in evaluations - particularly when investigator sites place such high importance on the concept. Being 'user-friendly' is an important criteria for software selection, but the trick is defining user-friendliness in a way that meets the needs of sites.
A critical point about the EDC selection process is that, generally, the decision-makers are the sponsor companies, and often the data management team for these companies plays an important role in the choice of EDC vendor. Although it is important that EDC software meet the data management requirements, it is absolutely critical that the initial users of the software (the personnel at the investigator site and the data monitors), readily accept the software. Without the site and monitor 'buy-in', data won't be entered into the site in a timely fashion and the software won't be used effectively. Without clean data available to data management, the usefulness of EDC is minimised.
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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 Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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