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European Pharmaceutical Contractor
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Bridging the Gap Between the Pharmaceutical and Preclinical CRO Industries
Pharmaceutical companies have traditionally outsourced a proportion of their preclinical development studies to contract research laboratories. This co-operation can be traced back to the mid-sixties and the proliferation of regulatory guidelines which followed the thalidomide disaster earlier that decade. At that time, the international requirements for protocol-driven toxicity studies for new pharmaceuticals put a strain on the resources of many drug companies.
The answer for many was to outsource individual studies to the rapidly-evolving contract research industry, pioneered by companies such as Huntingdon Research Centre in England and Inveresk Research in Scotland. These organisations turned their focus from experimental nutrition studies to the toxicity testing of drugs and other chemicals.
As the science of toxicology developed, so did the demands of the regulatory authorities, often resulting in inconsistencies between the various agencies. The introduction of Good Laboratory Practice (GLP) in 1978/9 also made it more difficult for some drug companies to perform studies themselves, adding further momentum to the growth of the CRO industry.
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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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