Clinical operations, also known as clinical trials, consist of practical research in the medical and pharmaceutical fields. The aim of such a process is to check whether care and products have side effects on humans. It is therefore essential to entrust clinical research work to a highly qualified provider.
What is clinical development?
When a drug is created, it cannot be marketed without professional research and biostatistical analysis. In order to obtain marketing authorisation, studies must prove the effectiveness of the drug both in healthy subjects and in people with the disease. The results will indicate whether or not the pharmaceutical product can be developed and placed on the market.
These clinical operations are divided into 4 phases. The first aims to show the tolerance of patients to the drug using very low dosages. The second is carried out on a few hundred participants and must indicate the tolerance of the subjects. The third is an evaluation of the efficacy of the drug. The aim is to conduct biotechnology research involving as many participants as possible. The aim is to show that the new treatment has the same performance as the reference treatment and, in the best case, is of superior quality. Finally, the fourth phase consists of further research, within the cro-monitoring framework, in order to propose an improved version of the product before marketing it.
Why use cro clinical operations?
The use of a biostatistics service provider is essential to obtain marketing authorization. This is cro, which is none other than the English abbreviation for “Contract Search Organization” which means “Contract Search Companies”. These companies may be contracted by private or public companies to research and market innovative pharmaceutical products.
The collaboration is formalized by a black and white contract between the biostatistics provider and the sponsor who would have used its services. These studies can be carried out in different fields, namely pharmacy and medicine. Other sectors are also concerned by this research, such as nutrition, cosmetics and biotechnology, not forgetting the veterinary field.
The results obtained from clinical cro operations?
You can use this type of service for various reasons, even if the ultimate goal is to determine the effectiveness of the treatment or pharmaceutical product. First of all, these studies make it possible to obtain a design of the study in all its aspects. A clear methodology must flow from this. Secondly, the research must be of a professional nature approved by the public authorities. Without the intervention of cro, no study can be considered as such.
This initiative also aims to protect patients and preserve their rights in accordance with GCP. This requires verification of the reliability of the data, since a misstep, misinterpretation or faulty application is enough to compromise the health and safety of study participants in the first instance and potential patients in the second. These specialized companies then carry out audits, monitoring and queries in accordance with the laws in force.