A brief view of the CRO industry
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.
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.
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 Research Organisation 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.
CROs take a flexible approach and offer a number of services including, protocol writing and CRF design, clinical trial design, regulatory applications, data management, laboratory, pharmacy etc. This enables CROs to provide single service components or a complete full-service solution to their clients’ clinical trial needs.
The Drug Development Process
Introducing new drugs or medical devices to the market can take up to twenty years and can cost almost £2 billion to administer. A number of aspects contribute to the conduct of research, product development and clinical trials, which not only includes the clients’ staff but also physicians, academic research specialists as well as patients or volunteers. The flow of data between researchers and the sponsor must maintained by the information system managers and this is monitored by the relevant regulatory authorities. Before the commencement of a drug development program, experts in health economics and other fields will make an analysis of the market that the new drug or medical device will be entering in.
TIP: An indicator of a good CRO is the specialist equipment and facilities like a ecg core 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…