Biotechnology

Over the past thirty five years the Clinical Research Organisation industry has progressed from a few small industrial providers offering a pressure valve to the pharmaceutical industry to a well established massive industry, growing by 10-15% once a year and employing approximately 100,000 professionals in hundreds of CRO companies worldwide.

There has been a proliferation of companies, amalgamations and acquisitions which has directed to the formation of some very large international players utilisaing as many as 15,000 personal globally. However, the market place is as diverse and as open for new ventures as it has been for many years; just very larger in size.

sadly, a huge factor for advancement of this industry has been the ever increasing regulatory requirements rather than an increase in real innovation. Yet new approaches in drug development such as personalised medicines and the advancement of biological medicines will certainly change the face of this industry. It is likely to continue to flourish but more in terms of size and diversity.

Entering unexpored regions is the base of all research and as such requires a constantly broadening range of specialists who can contribute to the new challenges within drug development.

Partnerships and close alliances have been the buzzword of the industry over many years and indeed it would seem like the logical evolution. Whilst other industries have embraced this concept it has not really materialised in the pharmaceutical research market.The process of Clinical trials are now better than ever before. The demand for standardised procedures dealing with large quantities of tests and data in some areas of full drug development have created a massive need 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 true innovation and it is not surprising that formidable pharmaceutical companies constantly scout for fresh partnerships in the biotechnology and Clinical Research industry.

Improvements 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 current political moves towards motivating more patients to put themselves forward for trials, does require reassurances to the public with regard to the safety of those Clinical trials. 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 Organisation market.