Clinical research organisation - a fresh take

Saturday, October 31st, 2009 | local info

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.

The global CRO market size is estimated at approximately £35 billion and continues to grow. Revenue increases at an annual rate of 14 to 16%.

Clinical trials conducted by CROs are completed on an average of thirty percent faster than those that are conducted in-house, according to an independent analyst. This means on average, four to five months worth of time is saved, equating to roughly £240 million to £300 million in increased revenue potential.

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

Approximately 100 thousand clinical professionals are employed by the clinical pharmacology industry on a global scale. They adhere to the highest ethical standards, complying with the Good Clinical Practices (GCP) and Good Laboratory Practice (GLP) put in place by regulatory authorities. CROs provide clients with an unmatched resource, therapeutic and regulatory proficiency, clinical and non-clinical drug development experience and up-to-the-minute technology.

With a flexible approach, CROs offer a range of services including clinical trial design, protocol writing and CRF design, regulatory applications, data management, pharmacy, laboratory etc. The range of services offered means that they are able to offer single service components or full-scale clinical trial solutions.

The Process of Drug Development

The process of bringing new chemical entities or medical devices into the market can sometimes take up to twenty years to carry out and cost up in excess of two billion pounds. In order to carry out the related research, product development and clinical trials, it requires the input from a number of different participants, including patients/volunteers, physicians and research associates, in addition to the sponsors own staff. It is necessary for information system managers to efficiently maintain the flow of data between the client and the research team, in addition to global regulatory authorities. From the outset, health economist experts will evaluate the market into which the product or medical device is being introduced.

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

This long-lasting, costly and complicated process is split into several stages. The first stage is known as pre-clinical research, lasting for 1-3 years, where new chemical entities or clinical devices are initially tested on animals. If these various tests prove to be effective and safe, the clinical testing in humans begins…

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