Tel: 0800 988 4437
There are five stages of clinical research in the Drug Development Lifecycle. This encompasses the process of developing a drug or device from pre-clinical phase to phase four. Clinical research broadly revolves around the trials that a drug or device undergoes to collect data regarding its safety and efficacy before it can be released into the market.
Clinical trials are a procedural process carried out in phases of development. In order for a drug to be released to consumers, it needs to be tested. This is why the process is conducted in phases. Drugs and devices require approval before proceeding in to the next clinical phase. The initial phase entails a lot of laboratory research, which involves experiments on animal and human cells. This then has to be approved by a regulatory agency before proceeding to the next phase. Following the first phase, the drug or device will have to move through the subsequent trials and be subjected to different clinical tests. The trials intensify with each phase and the drug or device is tested using a different sample each time, whilst addressing a variety of demographics and populations. Once the drug or device has been approved through the four-stage process, it is released into the marketplace for consumer or prescription-based purchase.
A career in Clinical Research involves a variety of different roles. ProClinical focuses on vacancies from a Clinical Trials Assistant (CTA) to a Clinical Research Associate (CRA) to a Clinical Project Manager (CPM) all the way through to Clinical Director level. These individuals are broadly involved in the supervising and collecting of data relating to the treatment of patients in clinical trials. A CRA will travel across a specific territory, visiting trial sites and making sure that patient monitoring is conducted in an accurate and consistent manner. Candidates may typically start as a CTA, gaining experience in trials and might progress through the ranks through to the level of CPM. Alternatively, any clinical experience can be very valuable as it may be the basis for entering a variety of roles in areas such as Regulatory Affairs, Medical Information, Data Management or Drug Safety.
Getting into the field of Clinical Research requires a life science degree. It is also important to get as much pre-clinical experience as possible, to open doors into many areas of clinical development.
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