Clinical research organisation – a fresh take

Clinical Research Organisations provide drug development services to the medical-device, biotechnology and pharmaceutical industries, where their sponsors are able to manage product-development processes that are more efficient and cost effective.

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.

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 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 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…