What is Clinical Research?

Clinical research is a branch of healthcare science ascertaining the safety and efficacy of medications, devices, diagnostic products and treatment routine, which may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

A complex network of sites, pharmaceutical companies and academic research institutions are involved in the clinical research ecosystem. This has led to a growing field of technology that is used for managing the data and operational factors of clinical research.

The benefits of participating in a clinical trial:

o getting access to new medical treatments which are not available yet to the public

o — obtaining expert remedial care with leading health-care facilities

o — taking an active part in your own health care

o — helping others by contributing to the medical research

What is Clinical Research Associate?

Clinical Research Associate (CRA), also called a clinical monitor or trial monitor, is a profession for those who enjoy doing Clinical Research:

A Clinical Research Associate is a health-care professional who performs many medical-research-related activities, chiefly clinical trials and also works with various settings, such as pharmaceutical companies, government agencies as well as medical research institutes. Different education and certification requirements may be essential to practice as a clinical research associate, depending on the influence.

Clinical Data Management in Clinical Research:

Clinical data management (CDM) is a critical phase in clinical research, which leads to:

· generation of high-quality

· reliable, and statistically sound data from clinical trials.

Clinical data management ensures the collection, integration and availability of data at applicable quality and cost. The ultimate goal of CDM is to guarantee that data support conclusions drawn from research. Achieving this goal defends public health and confidence in marketed therapeutics.

Regulatory Affairs Specialists’s role:

Regulatory affairs officers are the people who control the safety and efficacy of products by ensuring the appropriate licensing, marketing and legal acquiescence of pharmaceutical and medical products.

Their knowledge of scientific, legal and business issues are combined to certify products, which are developed, manufactured or distributed by a range of companies, meet the demanded legislation.

Safety Officers:

A Health and Safety officer (HSO) leads how an organization obey health and safety law, and also gives advice to both companies and employers on safe working environments.

A HSO usually works for the Health and Safety Executive (HSE), the local government, or a similar organization. HSO personnel are specially trained to supervise compliance with health and safety regulations. They work within private organizations, usually large ones, and also in the public sector, such as hospitals and schools.
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