CRO Industry at a Glance

By flower October 31st, 2009

Services provided by Clinical Research Organisations to the biotechnology, pharmaceutical and medical-device industries make it possible for clients to manage their product-development efforts more efficiently and at lower costs.

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.

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.

Employing thousands of clinical professionals throughout the world, the clinical pharmacology industry adopt the highest level of ethical standards and comply with the Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) outlined by regulatory authorities. Their clients are offered a supreme resource, the latest technology, non-clinical and clinical drug development experience and total proficiency in regulatory and therapeutic areas.

CROs take a flexible approach and offer a number of services including, protocol writing and CRF design, clinical trial design, regulatory applications, data management, laboratory, pharmacy etc. This enables CROs to provide single service components or a complete full-service solution to their clients’ clinical trial needs.

The Course of Drug Development

Introducing new drugs or medical devices to the market can take up to twenty years and can cost almost £2 billion to administer. A number of aspects contribute to the conduct of research, product development and the early phase clinical trial, which not only includes the clients’ staff but also physicians, academic research specialists as well as patients or volunteers. The flow of data between researchers and the sponsor must maintained by the information system managers and this is monitored by the relevant regulatory authorities. Before the commencement of a drug development program, experts in health economics and other fields will make an analysis of the market that the new drug or medical device will be entering in.

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

It is a long-term, pricey and complex process divided into a number of stages. Firstly, pre-clinical research which can last between one and three years, involves the testing of new drugs of medical devices on animals. Once these tests have been deemed safe and effective, clinical studies in humans can begin…

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