Medical Research

During the last 3 decades the Clinical Research Organisation industry has evolved from a few small entrepreneurial providers offering a pressure valve to the pharmaceutical industry to a well recognised multi billion industry, rising by 10-15% once a year and utilising in the region of 100,000 professionals in a multitude of CRO companies worldwide.

There has been a proliferation of companies, mergers and acquisitions which has guided to the structure of some very large international companies employing as many as 15,000 staff globally. However, the market place is as different and as open for new projects as it has been for many years; just very larger in size.

Unfortunately, a huge factor for advancement of this industry has been the ever escalating regulatory requirements rather than an enhancement in real innovation. Yet new approaches in drug development such as personalised medicines and the development of biological medicines will certainly evolve the clinical research industry. It is likely however to continue to flourish but more in terms of overall size and diversity.

Entering new territories is the foundation of all research and as such requires a constantly broadening range of specialists who can add to the new challenges within drug development.

The industry has seen partnerships evolve. 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 processes dealing with large amounts of tests and data in some areas of full drug development have created a large requiremenst and the subsequent formation of large and process driven Clinical Research Organisations frequently supplying the major pharmaceutical companies. However, large processing units are not the most appropriate environments for real innovation and it is not surprising that big pharmaceutical companies constantly look for new alliances in the biotechnology and Clinical Research industry.

Improvements is the product of brilliance 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 UK. 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 CRO market.