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European Pharmaceutical Contractor
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The use of electronic data capture (EDC) for clinical trials as an internal application by the pharmaceutical industry is continuing to gain momentum. To date, most EDC clinical trials are utilising EDC software on an application service provider (ASP) basis, meaning that the sponsor licenses the software on a trial-by-trial basis, relying on the vendor for the support functions of training, trial development, hosting and help desk, among others. Now that clinical organisations have become familiar with various EDC applications through outsourced projects, many are planning to bring this technology in-house. However, as with any software implementation project, significant planning and readiness is essential for success. At any given time there are tens of thousands of software projects taking place around the world. Up to two-thirds of projects will exceed schedule and/or budget, and of the most expensive projects, nearly half will be cancelled because they are viewed as being 'out of control'.
Successful software projects demand careful planning and deliberate execution. Conversely, software projects are more likely to fail for two reasons - lack of knowledge and/or lack of resolve to conduct software projects successfully. By fully educating yourself about what needs to take place during this transition and by carefully planning the execution, you can greatly improve your odds of success.
What
What do you hope to accomplish with EDC in-house? This question alone might give pause for thought. As a clinical trial sponsor, you most likely have EDC in the field at investigator sites and with monitors, but are you ready to design and build e-CRFs yourself? Are you able to provide hosting services for the central repository where all of the clinical data will ultimately be collected? Can you provide help desk services to address functional and/or technical questions from investigators and monitors at remote locations? Considering these questions can help you decide if you should take a phased approach to EDC implementations or bring it in-house all at once.
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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.
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