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.
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.
According to an independent analyst, clinical trials carried out by CROs are completed thirty percent faster on average than clinical trials conducted in house. This results in an average time saving of 4 to 5 months, which equates to approximately £300 million in increased potential revenue.
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.
With a flexible approach, CROs offer a range of services including clinical trial design, protocol writing and CRF design, regulatory applications, data management, pharmacy, laboratory etc. The range of services offered means that they are able to offer single service components or full-scale clinical trial solutions.
The Drug Development Process
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
This long-lasting, costly and complicated process is split into several stages. The first stage is known as pre-clinical research, lasting for 1-3 years, where new chemical entities or clinical devices are initially tested on animals. If these various tests prove to be effective and safe, the clinical testing in humans begins…
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