Clinical Operations/cGCP

The guidelines for GCP (Good Clinical Practice) are drawn by the ICH (International Conference on Harmonization). ICH's Technical Requirements for Registration of Pharmaceuticals for Human Use Tripartite Guideline E6(R1) is required to be followed by drug makers, CROs and other institutions that are involved in the clinical aspects related to the manufacture of drugs. These guidelines deal with clinical trial operations issues such as minimum requirements to be met the Study Investigator, Study Sponsors, Study Monitoring and Auditing, Clinical Trial Protocol and Amendments, Investigator Brochures and Essential documents required during the complete lifecycle of a clinical trial.

In our efforts to serve this vital area in clinical operations, we offer in-house workshops related to the specified ICH guidelines. The workshops are offered by our distinguished Ph.D-level clinical research faculty. The instructional material contains relevant presentations, example scenarios and a comprehensive module-based assessment of students. We make an effort to keep up with the current ICH-guidelines.