Data Management Clinical Research

The term Clinical Research refers to the complete biography of a drug, from its initiation in the laboratory to the time that it is introduced into the consumer market. Once a promising substance or molecule has been indentified, it will be subjected to stringent pre-clinical studies where various aspects such as efficacy and toxicity are analysed.

The data obtained as a result of carrying out these studies is submitted as an IND (Investigational New Drug) to regulatory authorities in order to gain approval to conduct human studies.

Human studies or clinical trials are carried out in four phases. The first phase is usually involved with the trials of a new drug or substance in a small group of individuals, often healthy volunteers. The aim here is to identify the safety tolerability and pharmacokinetics of the drug when administered in humans.

Phase II studies focus on larger volunteer populations and are aimed at studying the overall efficacy of the drug. Dose escalation for the next phase is also determined at this point.

Phase III Studies deal with even larger volunteer populations; focusing on the effects of the drug in different ethnic groups; comparisons with the standard drugs already on the market etc.

The fourth phase is usually conducted after the launch of the drug on the market. The aim here is to identify any adverse effects that have not already been determined.

The entire origination of a drug from the lab to the consumer market may take up to 18 years. However, the process of Clinical Research does not end here. It continues throughout the life-cycle of a drug; involving post marketing surveillance where the safety of the drug is monitored on a continual basis.

Contact Richmond Pharmacology for a full list of Clinical Research Services