Clinical Trials
Over the last 35 years the Clinical Research Organisation industry has developed from a few small capitalist providers offering a pressure valve to the pharmaceutical industry to a well recognised multi billion industry, increasing by 10-15% annually and utilising around 100,000 specialists in most of Clinical Research Organisations worldwide.
An increase in Pharmaceutical Research Business’, mergers and acquisitions which has directed to the pattern of some very large multinational players utilisaing as many as 15,000 personal worldwide. However, the market place is as diverse and as open for new projects as it has been for many years; just very larger in size.
regrettably, a huge factor for advancement of this industry has been the ever growing regulatory requirements rather than an increase in true innovation. Yet new approaches in drug development such as personalised medicines and the progression of biological medicines will undoubtedly evolve the clinical research industry. It is likely however to continue to flourish but more in terms of size and variety.
Entering new territories is the building blocks of all research and as such needs a constantly broadening range of professionals who can contribute to the new challenges within clinical research.
Partnerships and close alliances have been the buzzword of the industry over many years and indeed it would seem like the logical evolution. However the CRO market has not really adopted this concept.The process of Clinical trials are now better than ever before. The demand for standardised procedures dealing with large amounts of tests and data in some areas of full drug development have created a massive requiremenst and the subsequent formation of large and process driven Clinical Research Organisations frequently supplying the main pharmaceutical organisations. However, large processing units are not the most suitable environments for real innovation and it is not surprising that formidable pharmaceutical companies constantly scout for fresh partnerships in the biotechnology and CRO industry.
Innovation is the product of excellence usually delivered by an individual. However, large development programmes are reliant on large infrastructures. These are very different needs that the industry has and it is unlikely that they will ever be efficiently met by any one CRO company.
However large the portfolio of a CRO may be, the forte of any large organisation is the ability to process large amounts of goods or clinical data management in a uniform way. The advantage of smaller companies is their ability to adapt to new challenges quickly and deliver true innovation. It follows that the diversity we currently see in the CRO market place is likely to continue providing the opportunities for new entrants to the market|However big the Clinical Research Industry is, the strong point of any formidable company is to have consistency with processing large amounts of products, services or data .
The increasing numbers of patients needed for trials, does require reassurances to the public with regard to the safety of those Clinical trials London. The number of regulations is likely to increase which will in turn create an increase in bureaucracy. This again will create a demand for larger organisations to process large amounts of data creating very large databases. Yet more regulations do not necessarily make research safer as the recent unprecedented tragedy at Northwick Park Hospital in London has shown. In this instance all relevant regulations were followed yet the information available was not evaluated in the appropriate way and as a consequence a far too high dose was given to a group of six previously healthy volunteers. The challenge in controlling such complex issues is to find and involve a highly specialised expert in a particular field and to ensure that all available data is evaluated appropriately in the approval process. This represents a challenge, and in this instance, again, size will not be the answer.
Innovation and research require a large arsenal of research tools and services as well as an effectively functioning network, facilitating the access to and exchange of information, both on available services and expertise. It is the creation of these knowledge based networks which will create the most exciting opportunities for the future of a diverse and thriving Clinical Research market.
This entry was posted on Tuesday, July 28th, 2009 at 5:18 am and is filed under General. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.