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.
It is estimated that the worldwide CRO market is worth over £35 billion and this figure is still growing. The annual rate at which revenue increase is roughly fourteen to sixteen percent.
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.
The CRO industry is global. Leading companies are familiar with regulatory affairs and common business practices in many countries across the globe.
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 Drug Development Process
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 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…