Clinical Research - Trial and Data Management

Foresight Institute of Management & Research
In Pune

Price on request
You can also call the Study Centre
97644... More
Compare this course with other similar courses
See all

Important information

  • Course
  • Pune
Description

Important information
Venues

Where and when

Starts Location
On request
Pune
411002, Maharashtra, India
See map

Course programme

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 is conducted in four 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 effect and also to check for 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 favourable, 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 doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Compare this course with other similar courses
See all