A brief view of the CRO industry
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%.
An investigation carried out by an independent analyst concluded that clinical trials conducted by CROs are competed on average 30 % quicker than those carried out in-house. This means a typical time saving of 4-5 months, equivalent to almost £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.
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.
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
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 the early phase clinical trial, 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
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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