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Pharmaceutical Clinical Data Management

Clinical Data Management and CDISC standards:

Many pharmaceutical and biotechnology companies are working on the development of new drugs, compounds and devices for betterment of human health and increase the quality of life globally. This process of drug development and discovery when reaches the stage of testing in human volunteers involves people from various specialty and varied background. Final goal of any human trial is to be able to investigate the safety and efficacy of the investigative compound or device in human subjects within the regulatory guidelines and accepted standards of safety, patient care and data interpretation.

The initial stage of any clinical study involves the collection of observational, laboratory and other data of the trail subjects and is the most critical part in the study life cycle. It is this collected data, which will be used in analyzes of final end points of any study. The quality of data and accuracy then becomes most important thing. The great

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Generics Revolutionizing the Indian Healthcare Industries

Revolutionary Effect of Generics In Healthcare Industry:

The Indian pharma industry traces back its origin to 1903 when Bengal Chemical and Pharmaceutical Works was initiated in Calcutta by Professor P.C. Roy Pre?independent India largely remained dependent on other countries for medicines. The major suppliers were UK, France, and Germany. The new government post-independence focused on self-dependence and emphasized on industrialization that also included pharmaceuticals. As a result Hindustan Antibiotics Ltd. (HAL) came into existence in 1954, and following it was Indian Drugs and Pharmaceuticals Ltd. (IDPL) in 1961.

The IDPL program proved India to be capable of producing drugs at very reasonable prices and also helped in developing human and physical capital, and in establishing a network of research institutes. In spite of these facts, till 1970s the pharma industry in India was dominated by multinational companies (MNCs), which continued minimum physical operations in India.


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