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| home > epc > winter 2002 > rationalised analytical laboratory services for tomorrow's clinical trials |
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European Pharmaceutical Contractor
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For many years now, there has been centralisation of laboratory analysis for particular aspects of clinical trials. The rationale of centralisation to ensure consistent data was realised earlier in the bioanalytical portion of studies than in those related to the safety and efficacy of new pharmaceutical entities. Hence, it is only since the early 1980s that the 'central' laboratory has evolved and its purpose today is much more diverse in terms of service offerings (and client requirements) than it was in the early days.
Recent developments in regulatory requirements and analytical capabilities have brought about a potential for the bioanalytical and central laboratory to form much closer working relationships. Indeed, the rapidly expanding field of pharmacodynamic (PD) biomarkers means that there is an increasing requirement for results from analytical platforms commonly used in the central laboratory to be produced to a standard that will satisfy regulatory authorities such as the FDA - much like pharmacokinetic (PK) data.
This is particularly the case when assay kits are not being used for their intended purpose. Keeping apace of these changes and developments sets a significant challenge for the contract laboratory. Within large contract research organisations (CROs) these analytical disciplines are often under different management structures and may be totally independent of each other from operational and study acquisition standpoints. Here, the challenge is to ensure that the most appropriate method and analytical platform are used. This article will try and provide an insight into the important issues of ensuring that regulatory requirements and quality issues are met, whilst patient, volunteer and animal health welfare considerations are maintained.
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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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