A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering Or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug. 

Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research and Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.

 

India has developed into a super power for IT skills and has become a major hub for pharmaceutical and biotech manufacturing And contract research, the outsourcing business in various other segments is also exhibiting promise. Clinical trial data management and statistical analysis is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business. The author reflects on the data management business in India and reviews the emerging outsourcing models in this growing industry. He has also attempted to work out a break-even analysis considering the projected investment on high quality and costly infrastructure like; hardware, software and human resources to augment the business and regulatory requirements of the industry.

 

Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.In general, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to: identifying new information about hazards associated with medicines preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function. 

 

Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure. Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.