CRO Industry at a Glance
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.
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.
CROs are of an international industry. Leading Clinical Research Organisations will be acquainted with the associated rules, regulations and good clinical practices in place in many 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.
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 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 the early phase clinical trial, 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 core lab
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…
