Clinical Trials is a systematic study for new drugs in human subjects to generate data for discovering verifying the Clinical Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the object of determining safety and efficacy of the new drug.

Clinical Trials is conducted in 4 phases:

Phase I Trials
This is the first time the new drug is administered to a small number around 20 – 80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.

Phase II Trials
In this phase the medicine is administered to a group of approximately 100 – 300 informed patients to determine its effects and also to check any unacceptable side effects.

Phase III Trials
In this phase the group is between 1000 and 5000, for the company to use statistics to analyze the results. If the results are favorable, the data is presented to the licensing authorities for a commercial license.

Phase IV Trials
This is a surveillance operation phase after the medicine is made available to the doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Objectives 

The Clinical Research industry world over is growing at an unparallel rate. It has opened up new vistas of employment for a large number of trained professionals. 
 

The specific objectives of the programme are: 

• To develop manpower in the area of Clinical Trials. 
• To promotes ethical Clinical Research in the country. 
• To achieve professional excellence, thereby enhancing a Clinical Research culture in India. 
• To encourage Clinical Research methodologies. 
• To keep the Indian Clinical Research Industry abreast of changing times.
• To fill the vacuum created due to lack of skilled manpower in Clinical Research Industry by imparting innovative and intellectually challenging education in the segment.