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 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.

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.

The CRO industry is global. Leading companies are familiar with regulatory affairs and common business practices in many countries across the globe.

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.

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 Course of Drug Development

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 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…