- Patient selection
- Informed Consent, AV recording, Electronic data capture, presenting updates at relevant meetings is followed to its minute details. The site has been audited by national & international agencies.
India is today poised as one of the favorable destination for conducting global clinical trials in terms of large patient populations, skilled manpower, cost effectiveness, favorable economic and research environment etc. A clinical trial is a process of testing a medication for its safety and effectiveness, either in comparison to a placebo or an already existing treatment. Clinical trials are part of research, which leads to development of a new treatment. Any new treatment has to be cautiously evaluated through the several phases of the trial before it can be used to treat people. No trial can be executed successfully without the voluntary participation of subjects. All the subjects are given a document called as Informed Consent Form, which mentions the purpose of the study, procedure, and the risk and benefit involved in the study. Before any trial procedures are started, this document needs to be signed voluntarily by the patient. The decision to participate or not, rests entirely upon the subject, and he / she can terminate his / her participation at any time, if not benefiting from the treatment. All trial procedures have to be executed according to the ICH- GCP guidelines; these are a set of standards, which are used internationally for the conduct of trials, ensuring the rights, safety and well being of the trial subjects.
All clinical trials are commonly divided into 4 phases. The drug will be approved for use in the general population if it passes through phase 1, 2 & 3.