CLINICAL RESEARCH :

• Description:

Clinical research refers to all research carried out on humans (healthy or sick people). It focuses on improving knowledge of diseases, developing diagnostic methods and new treatments or medical devices to ensure better patient care. It is much framed and respects a precise study protocol and is only realized under certain conditions.

There are 2 main types of clinical studies:

Observational studies (cohort study, epidemiology)

Interventional studies or clinical trials

As part of the development of new drugs, clinical trials are conducted in 5 steps:

Phase 1

First administration in humans

Phase 2

First administration in patients

Phase 3

Therapeutic efficacy

Phase 4

The Marketing Authorization

Phase 5

Monitoring and evaluation of side effects

CLINICAL DATA MANAGEMENT :

• Description:

A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for clinical data management can be self-contained or part of the functionality of a CTMS. A CTMS with clinical data management functionality can help with the validation of clinical data as well as helps the site employ for other important activities like building patient registries and assist in patient recruitment efforts.

The CDMS can be broadly divided into paper-based and electronic data capturing systems.

PHARMACOVIGILANCE:

• Description:

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word “pharmacovigilance” are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation)

Pharmacovigilance is needed for the prevention of drug-induced human suffering and to avoid financial risks associated with unexpected adverse effects. In conclusion, medicines on the market need continuous monitoring in every country.

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