Clinical research in Bangalore

11th May 2011
By raju in Medical Malpractice
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What is Clinical Trial/Research?
The studies conducted to evaluate the quality, safety and efficacy of investigational products, be it drugs, biological, medical devices or medical procedures on humans in a strictly scientifically controlled setting is termed as Clinical Research.

The basic role of a clinical research associate, also referred to as a monitor, is to supervise the entire progress of clinical trials, initiated and conducted by physicians at hospitals, clinics, physician's offices and other medical establishments. Apart from being responsible for the health and well-being of clinical study participants, clinical research associates have to ensure the accuracy, quality and integrity of the scientific data collected during trials.

The extensive set of roles and duties characteristic to practicing clinical research associates include ensuring that the physicians respect good clinical practices and study protocols, checking the required documentation for each study participant, ensuring that all side-effects and adverse physical responses are appropriately reported and filed and ensuring the proper filing of various regulatory documents.

A CRA mainly deals with administering and monitoring the progress of a Clinical Trial. A CRC, as the name suggests, coordinates the trial at the site. A CRC assists the Investigator in the trial procedures. The Investigator is a person (Doctor) responsible for the conduct of the study at the trial site. Investigator is responsible for the rights, health and welfare of the study subjects.

Scientific writers are the people who prepare documents like the Protocol, which assists in regulatory approvals for the conduct of the trial. Biostatistician is a person who is knowledgeable in the field of mathematics and applies it to the biological systems. The role of a biostatistician in the field of Clinical Research is to analyze the data collected from the trial. Quality Analysts ensure that the maintenance of quality throughout the conduct of the trial.

Clinical research continues throughout the lifetime of the test article to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the test article is released into the market, and such as pharmacovigilance where the safety of marketed drugs, biologics or medical devices are monitored.

The focus of clinical research is wide enough to include important items such as data management, medical writing, regulatory consultation, and biostatistics.
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