Clinical research organisation – a fresh take

By providing drug development services to the biotechnology, pharmaceutical and medical-devices industries, CROs enable their clients to manage product-development processes more efficiently and more cost effectively.

It is estimated that the global CRO market size is close to £35 billion and still growing, where it has been forecasted that revenue increases at an annual rate of fourteen to sixteen percent.

According to an independent analyst, clinical trials carried out by CROs are completed thirty percent faster on average than clinical trials conducted in house. This results in an average time saving of 4 to 5 months, which equates to approximately £300 million in increased potential revenue.

The CRO industry is worldwide. Industry leaders recognise the regulations and ethical business practices in place in numerous countries.

The Clinical Research Organisation industry employ roughly 100,000 clinical professionals across the globe. In addition to this, CROs hold high ethical standards and fully comply with Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) that have been published by regulatory authorities. Clients are provided with a superior resource, clinical and non-clinical drug development experience, therapeutic and regulatory expertise and modern technology.

Taking a flexible approach, CROs offer a variety of services encompassing clinical trial design, regulatory applications, pharmacy, laboratory, protocol writing and CRF design, data management etc. This vast service offering allows for CROs to provide a single service component or a complete bespoke clinical trial solution.

The Drug Development Course

When new drug entities or medical devices are introduced into the market, this process can take up to twenty years and cost in the region of £2 billion. Various components are necessary for the associated research, product development and clinical trials, encompassing the sponsors’ staff as well as research associates, patients or volunteers and physicians. Information managers are required to maintain the flow of data between the sponsor and its researchers, as well as international regulatory bodies. Experts in health economics and other related areas will assess the market before the launch of a new chemical entity or medical device into the market.

TIP: An indicator of a good CRO is the specialist equipment and facilities like a core ecg lab

This process is costly, intricate and longstanding and is broken into numerous stages. Pre-clinical research concerns the testing of new medical devices or drugs on animals and can last between 1 and 3 years. After this testing has proven to be safe and effective, human clinical trials can commence…

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Cost effective clinical trials are being provided in various countries in Asia and Eastern Europe, the main reason for this is to increase the growth and revenue for this specialist industry, This has had an impact on many Pharmaceutical and Bio-tech companies who are now outsourcing the clinical trial research to these countries.A large amount of specialists in the pharmaceutical industry have recognised this trend and are making use of this cost effective service offered abroad due to the large amount willing volunteers and also due to the international increase in demand for healthcare products.

The conduct of Clinical Trials has become cost effective in these countries.

Organisations such as pharmaceutical and biotechnology companies, as well as contract service providers, are faced with some challenging ethical business issues as sales and research continues to boom in these regions. Due to a lack in logistical and institutional capacity, many of these countries are faced with situations which lead to government representatives and business leaders accepting bribes or becoming involved in other corrupt acts with the aim of securing approval to conduct a certain clinical trial, or acquiring the materials to conduct these studies.

The Corruptions Perceptions Index, monitored by Transparency International (a not-for-profit organisation based in Berlin), affords a basis for which the risk of corruption can be approximated.The index is intended to rate countries based on the opinions of state analysts and business executives.India was ranked 85th , China 72nd and Brazil 18th out of 180 countries where the country ranked the lowest would be considered to be the least corrupt.

Pharmaceutical and Biotechnology organisations need to consider this before looking to outsource their studies in other countries. They need to be fully aware of the ethical violations that there CRO partners may encounter. If these organisations are ignorant towards this, the clinical trial may in turn be jeopardised or the trial outcome report could be made invalid if the CRO carrying out the study have breeched any ethics violations that may be in place. This could be detrimental for the organisation’s reputation, and could hinder any business in that country for the future.

Nicky Hargreaves has over 24 years in R&D, manufacturing, quality and regulatory affairs.”Trusted UK based Clinical Research organisations or pharmacology companies who provide  professional clinical trials (providing the statistical analysis, Clinical Data Management and the clinical research) that assists with the development of new drug entities are known to be the top resource.” Says Nicky; who is a microbiologist by training and has managed projects in numerous divisions, including pharmaceutical, medicinal, OTC, oral healthcare and animal healthcare.

* Before taking any medical advise you should consult your doctor. *